More than half of abortions in the U.S. are medication abortions, done early in pregnancies. But less than a year after the Supreme Court overturned Roe v. Wade, federal court rulings have raised questions about the future availability of mifepristone, the first of the two-drug combination used in those abortions.

On April 7, a District Court judge suspended the Food and Drug Administration’s approval of mifepristone, which occurred 23 years ago, while another judge ruled in a separate case that the FDA couldn’t change the current availability of the drug. Less than a week later, an appeals court gave both sides part of what they wanted: The court said the FDA’s approval would remain valid, but the agency’s later changes to increase access to the drug would still be suspended while the case proceeds.

The federal government and the drugmaker have appealed that decision to the Supreme Court. The restrictions on mifepristone, as ordered by the appeals court, would take effect on April 15, unless the Supreme Court intervenes.

Update, April 21: The U.S. Supreme Court, by a 7-2 vote, stayed the lower court’s ruling on April 21. That means no restrictions on the FDA regulations of mifepristone during the appeals process.

Here we answer questions about the court rulings, mifepristone and what may happen next.

What is mifepristone?

Mifepristone, sold under the brand name Mifeprex and also known as RU-486, is a drug approved by the FDA to terminate pregnancies through 10 weeks (70 days) of gestation. It’s the first of two medicines that are taken together as part of medication or medical abortion in the U.S.

In the FDA-approved regimen for medication abortion, one mifepristone pill is taken by mouth on the first day. Between 24 and 48 hours later, the patient places two tablets of another medicine called misoprostol in each cheek pouch, and lets them dissolve. Patients typically begin to expel pregnancy tissue two to 24 hours after taking the second drug. Patients then follow-up with their health care provider a week or two after taking mifepristone to ensure that the pregnancy has been successfully terminated.

Mifepristone ends pregnancies by blocking the hormone progesterone, which is required to maintain a pregnancy. Without the progesterone signal, the uterine lining with the implanted embryo or fetus is shed. Mifepristone also makes the uterine muscle more sensitive to prostaglandins, including misoprostol, which triggers contractions and helps open the cervix. 

In some countries, misoprostol is used alone in medication abortions, but research shows the drug combo is more effective and may have fewer side effects. While FDA’s approved mifepristone regimen requires misoprostol, misoprostol is not FDA-approved for abortion, so technically it is used off-label for that purpose. Off-label prescribing, which is common, is when a doctor prescribes a drug in a different way or for a different condition than the one for which it was approved.

Outside of medication abortion, mifepristone is used off-label to help patients experiencing miscarriages or stillbirths expel pregnancy tissue and avoid procedures. The pill is also FDA-approved to treat high blood sugar in certain Cushing’s syndrome patients.

When was mifepristone approved, and how has it been regulated?

The FDA approved mifepristone for medication abortion in September 2000, after reviewing the available evidence and finding that the benefits outweighed the risks. 

This included four phase 3 clinical trials: two in the U.S., and another two in France, where the drug was developed and was approved in 1988. It also included post-marketing safety data from numerous other countries, including France, Sweden and the U.K., all places where the drug had been in use since at least the early 1990s. An FDA document shows that at the time of approval, mifepristone was approved in 21 other countries (see page 9).

In 2000, the mifepristone approval pertained to pregnancies seven weeks along or less. Due to some safety concerns — particularly the fact that mifepristone sometimes fails, should not be given to people whose pregnancies are located outside of the uterus, and rare excessive bleeding can occur — the agency imposed several restrictions, later known as a risk evaluation and mitigation strategy, or REMS, on mifepristone. 

Under the regulations at the time, the drug could not be sold in pharmacies or online, and instead was supplied directly to doctors meeting certain qualifications, including being able to accurately date pregnancies, diagnose ectopic pregnancies, and having the ability to perform or arrange for any necessary surgery. Certified doctors, who gave mifepristone to patients in person, also had to provide a “medication guide” to patients and agree to report any adverse events to the drugmaker.

Over the years, the FDA continued to monitor the safety and efficacy of mifepristone and made slight modifications to the required restrictions. Most notably, in 2016, the agency extended approval to pregnancies up through 10 weeks of gestation, allowed health care providers other than physicians to become certified to provide mifepristone, and reduced the required office visits for patients from three to one. Given 15 years of safety data showing “the known serious risks occur rarely” — and no sign of new safety concerns — the agency also dropped the requirement that providers report all adverse events, requiring only deaths to be reported.

In April 2019, the FDA approved a generic of Mifeprex.

During the COVID-19 pandemic, the FDA did not enforce the in-person dispensing requirement, allowing mifepristone to be mailed to patients. In 2023, after reviewing the evidence, the agency dropped the in-person requirement from the REMS program altogether and added a requirement that any pharmacies that offer the drug be certified.

Current REMS regulations therefore require that a certified health care provider prescribe mifepristone, but that person does not need to be a physician, nor does the pill need to be given to the patient by that provider. Instead, mifepristone can be mailed to patients by certified pharmacies. Patients still must be given a medication guide and health care providers must inform patients of the risks of using mifepristone.

On its website, the FDA notes that the agency has never “removed a drug with a REMS from the market due to new or serious issues that could not be mitigated by the REMS.”

Today, mifepristone is approved in about 80 other countries, according to the FDA.

Where did this lawsuit challenging the FDA approval begin?

A group of four anti-abortion organizations and four physicians filed a lawsuit — Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration — in November 2022 in the U.S. District Court for the Northern District of Texas. That was five months after the Supreme Court overturned Roe in a 5-4 ruling that said the “Constitution does not confer a right to abortion … and the authority to regulate abortion is returned to the people and their elected representatives.” The plaintiffs challenged the FDA’s approval in 2000 of mifepristone and subsequent REMS modifications to how the drug can be prescribed and dispensed.

On April 7, Judge Matthew J. Kacsmaryk, an appointee of former President Donald Trump, sided with the plaintiffs’ arguments, ordering a “stay,” or suspension, of the approval and subsequent actions related to it.

Legal experts have said this is the first time a judge has gone against FDA objections and overruled a drug it has approved. “Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination,” the federal government said in a January 2023 brief.

The federal court’s order is a preliminary injunction, which is issued before a trial and final judgment in the case if the plaintiffs show they are likely to succeed in the lawsuit on its merits and there’s a threat of “irreparable harm” without the injunction, among other factors.

Kacsmaryk delayed his order for seven days to allow time for an appeal to the 5th U.S. Circuit Court of Appeals, which the federal government and Danco Laboratories, a manufacturer of mifepristone and also a defendant in the case, promptly filed.

What about the other, conflicting District Court ruling?

In February, Democratic attorneys general filed suit, also against the FDA, saying the agency should remove restrictions on who can prescribe and dispense mifepristone. On the same day as the Texas court ruling, District Court Judge Thomas O. Rice in the Eastern District of Washington granted a preliminary injunction barring the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in the 17 states, plus the District of Columbia, of the plaintiffs.

The ruling by Rice, an appointee of former President Barack Obama, doesn’t change the FDA’s restrictions under REMS. The plaintiffs argue these “burdensome restrictions” on a drug that has been administered for more than 20 years “with only ‘exceedingly rare’ adverse events” have “no basis in science. It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”

In addition to D.C., the states are: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota and Pennsylvania. Abortion is legal in all of those states.

Rice later confirmed that the rulings in the Texas case, including from the appeals court, had no bearing on his order pertaining to those states.

What did the appeals court say?

On April 12, the 5th Circuit overruled part of Kacsmaryk’s injunction. The three-judge panel — two appointed by Trump and one by former president George W. Bush — said the anti-abortion groups had waited too long to file suit against the FDA’s 2000 approval of mifepristone, so that couldn’t be suspended. The challenge was beyond the statute of limitations. But the appeals court ruled that the agency’s subsequent actions on the drug could still be challenged and would be suspended under Kacsmaryk’s order while the case proceeded.

As we explained, those subsequent actions include allowing distribution to patients via mail and the FDA’s 2016 REMS that allowed mifepristone to be prescribed up to 10 weeks of gestation rather than seven weeks and permitted health care providers who aren’t doctors, such as nurse practitioners, to prescribe it.

The 5th Circuit ruling is temporary as the appeal proceeds. The court set oral arguments for May 17.

What are some of the legal arguments in the case against mifepristone?

There are many legal claims in this case, but David S. Cohen, a professor of law at Drexel University and an expert in legal issues concerning abortion, explained to us that there were three main claims in Kacsmaryk’s April 7 ruling in the District Court: that mifepristone isn’t safe, that the FDA incorrectly used a regulation in approving it, and that the FDA violated an 1873 law that would ban the mailing of the drug. On all three, the judge sided with the plaintiffs over the FDA.

The FDA approval process requires drugmakers to demonstrate safety and effectiveness through clinical trials, and after a drug is approved, the agency continues to monitor its use. In its brief, the FDA said its 2000 approval “rested on a comprehensive evaluation of the scientific data,” that subsequent evidence “confirms that mifepristone has been demonstrably safe and effective in practice, when considered based on clinicians’ real-world experience prescribing the medication,” and that serious adverse events “are rare,” according to the agency’s review of the scientific literature.

We’ll have more about mifepristone’s safety below.

Kacsmaryk, though, wrote that “[c]ompelling evidence suggests” the FDA’s statistics on adverse events “understate the negative impact the chemical abortion regimen has on women and girls,” using terminology for the two-drug regimen preferred by anti-abortion advocates. (The judge also repeatedly referred to a fetus or embryo as an “unborn human.”)

Among the evidence offered by the plaintiffs on mifepristone’s safety is a 2021 study that we’ve written about before on emergency room visits by Medicaid patients authored by Charlotte Lozier Institute, an anti-abortion group. Kacsmaryk cited it in his ruling, saying that medication abortions “are over fifty percent more likely than surgical abortion to result in an emergency room visit within thirty days.” But as we’ve explained, the higher rate of visits doesn’t equate to a higher safety risk. Other research shows most ER visits by women with Medicaid, who may not have a primary care doctor, after a medication abortion weren’t for serious complications.

Kacsmaryk also argued that medication abortion is harmful to women’s mental health. He cited a study, co-authored by a researcher with Charlotte Lozier Institute, that analyzed 98 anonymous blog posts from women who had medication abortions and visited a website called “Abortion Changes You.” Many of the women who submitted a post regretted their abortions.

But submissions to such a website are unlikely to be representative of the experience of most people. Moreover, other research, including the most rigorous work, has not found that abortion causes mental health problems such as depression, anxiety or suicidal thoughts, or leads to drug use, as some have proposed. The best studies compare outcomes in people who had abortions with those who were denied an abortion. One such study, known as the Turnaway Study, not only found no increase in mental health issues in those who had abortions, but found that those who were denied an abortion were more likely to suffer anxiety and have low self-esteem in the short term, experience poor physical health, and to fall below the federal poverty level, among other negative outcomes.

On the FDA regulation point, the judge said the FDA erred in using a regulation called Subpart H in approving mifepristone. Subpart H allows for approval of new drugs that “have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” It also allows the FDA to impose restricted distribution requirements, as a Government Accountability Office report on mifepristone’s approval explains.

It took more than four years for the FDA to approve the drug after the drug sponsor submitted its application.

Kacsmaryk agreed with the plaintiffs that this regulation shouldn’t apply in this case because pregnancy isn’t an “illness” but rather “a normal physiological state most women experience.”

The FDA said that neither the agency nor Congress had adhered to that narrow interpretation. The FDA said the regulation applies to drugs used for serious “conditions,” as explained in its final rule. Congress later “ratified FDA’s understanding of its regulation” by using the language “disease or condition” in a law pertaining to the REMS framework.

Finally, Kacsmaryk said the plaintiffs are likely to succeed in an argument that the FDA violated the 1873 Comstock Act by allowing the distribution of mifepristone via the mail, as it first did during the coronavirus pandemic in 2021. The judge wrote that the law prohibits mailing anything that would produce an abortion. The FDA argued that misconstrues the law — which was known as a “chastity” law and originally prohibited mailing birth control as well as any “obscene, lewd or lascivious” publications.

“As the Department of Justice’s Office of Legal Counsel has explained, however, since the early 20th century the Comstock Act has been understood ‘not to prohibit all mailing or other conveyance of items that can be used to prevent or terminate pregnancy,'” the FDA said in its brief.

The FDA sought to have the suit tossed out, arguing that the plaintiffs didn’t have standing. In order to sue in federal court, a plaintiff must show “standing,” meaning that they have been harmed, the defendant caused that harm and a ruling by the court could remedy the harm. Both the circuit court panel and district judge have ruled that the plaintiffs do have legal standing, although a number of legal scholars have questioned this.

What more did the appeals court say about these arguments?

On the Comstock Act, the appeals court said it couldn’t fully explore how and whether the law should apply given the speed of the District Court’s ruling. But the judges wrote that the “uncertainty” over the law’s applicability “favors the plaintiffs” because the defendants had the burden of proving their arguments to get the court to overturn the lower court’s injunction.

“Our decision to grant partial relief does not reflect our view on any merits question,” the judges wrote. But they did say the plaintiffs were “unlikely” to fail in claiming the FDA, in its 2016 and subsequent REMS changes, violated an “arbitrary-and-capricious standard” it must meet under the Administrative Procedure Act. The APA lays out how federal agencies can make rules and how the courts can review them. Under the arbitrary-and-capricious standard, agencies “must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made,” the judges wrote, citing prior court rulings.

The appeals court did not delve into the meaning of “illnesses” in Subpart H.

As for the court’s decision not to also overturn the District Court’s stay on the FDA’s 2016 and later changes, the judges wrote that the government and Danco didn’t show how there would be “irreparable harm” from leaving that suspension in place.

How safe and effective is mifepristone?

Numerous studies have demonstrated that mifepristone is safe and effective for terminating early pregnancies.

According to mifepristone’s prescribing information, 22 clinical trials, including seven in the U.S., have evaluated mifepristone when used with misoprostol at 10 weeks or less of gestation. The results show patients on average have a complete medical abortion at least 96.2% of the time, meaning the drug fails in less than 4% of cases. 

The failure rate is even lower — below 2% — for pregnancies terminated at seven weeks or less, although it increases to less than 7% during the 10th week of gestation.

Medication abortion with mifepristone is also safe. While most patients experience side effects, including nausea, weakness and fever, serious ones are rare. Ten clinical trials, according to the prescribing information, found that a serious adverse reaction, such as a blood transfusion or serious infection, affects fewer than 0.5% of people.

Many other studies have borne this out, finding serious adverse events are typically below 1%, and often well below. As we’ve written before, a 2015 paper published in Obstetrics & Gynecology reviewed 20 other studies that collectively included more than 30,000 patients, and found that “[s]evere adverse events like blood transfusion (0.03–0.6%) and hospitalization (0.04–0.9%) are uncommon” (one co-author of that paper reported being a consultant for Danco).

Cramping and bleeding — heavier than a normal period — are expected with medication abortion. The main concern is excessive bleeding, which can be dangerous and could indicate that the medications failed and the individual needs to complete the abortion with a procedure. Another concern is infection, which could lead in rare cases to sepsis.

It’s important to note that not all people are good candidates for medication abortion, as the drugs should not be used in people with ectopic pregnancies, those using an IUD, or in people with certain health conditions or those taking certain medications.

Death is exceedingly rare. Through June 2022, the FDA received 28 reports of deaths out of the approximately 5.6 million people who took mifepristone since its approval. Reported deaths do not necessarily mean the death was caused by medication abortion; a number of the deaths were from causes that do not have any link to the medication, including suicide, homicide or suspected homicide, and drug abuse. Two deaths were due to ectopic pregnancies, while nine were for sepsis. Eight of the nine sepsis cases involved vaginal use of misoprostol, which is not part of the FDA-approved regimen for medication abortion.

Death after medication abortion is so rare that it’s difficult to determine an accurate death rate, but one U.S. study suggests it is around 1 per 100,000 people. This is similar to the overall abortion death rate and significantly lower than the risk of dying from childbirth.

Compared with an abortion procedure, medication abortion is less effective, but the difference is small (procedural abortion is commonly referred to as surgical abortion, even though no there is no incision).

Some studies suggest that compared with an abortion procedure, medication abortion is associated with a higher rate of adverse events, although the differences are usually small or primarily apply to side effects that are not serious.

One 2015 paper, analyzing outcomes from more than 50,000 Medicaid patients in California, found that major complications occurred in 0.31% of medication abortions versus 0.16% in procedural abortions.

A study from Finland, cited in Kacsmaryk’s ruling, found that total adverse events were nearly four times higher in medication abortions compared with abortion procedures. But that was just one finding from the study, which concluded by saying, “termination of pregnancy by means of either medical or surgical methods is associated with a low level of serious complications.”

Dr. Oskari Heikinheimo, a professor of obstetrics and gynecology at the University of Helsinki who was the senior author of the paper, told us that “[s]erious complications or serious adverse events were rare and similar after medical or surgical abortion.” 

The higher rate of total adverse events, he said, was driven by concerns women had about uterine bleeding. Because a procedural abortion removes the pregnancy tissue, while a medication abortion does not, people experience more bleeding with mifepristone, even if it’s not harmful.

Another contributing factor, Heikinheimo said, is that abortion is a public health service in Finland, so “women had a low threshold of attending medical care, without significant expenses to them and no need to travel long distances.” He also noted that the study was performed when medication abortion was new to Finland. As with the U.S., medication abortion was introduced there in 2000, and the study covered 2000 to 2006.

Far from thinking his study means medication abortion is unsafe, Heikinheimo said medication abortion has an “impressive safety” record, “even if provided via telemedicine.” He cited a U.K. study that found no safety or effectiveness concerns with providing medication abortions without an in-person visit or ultrasound.

Thus, while there are differences between mediation abortion and an abortion procedure that patients should consider, the medical consensus is that both options are safe and effective. 

Indeed, a 2018 review from the National Academies of Sciences, Engineering, and Medicine found that “clinical evidence clearly shows” that all methods of legal abortion in the U.S., including medication abortions, “are safe and effective” and that “[s]erious complications are rare.”

What happens next legally?

In emergency applications, the federal government and Danco have appealed the circuit court’s order on the preliminary injunction to the Supreme Court.

The circuit court had set a date of May 17 to hear oral arguments in its review of the District Court’s injunction, but whether that happens is subject to what the Supreme Court does.

Update, April 21: The U.S. Supreme Court, by a 7-2 vote, stayed the lower court’s ruling on April 21. That means no restrictions on the FDA regulations of mifepristone during the appeals process.

Eventually, the case would be heard on its merits in the District Court in Texas. And that court’s final judgment would likely be appealed to the circuit court and ultimately to the Supreme Court. That process could take a couple of years.

What can the FDA do as the cases move forward?

Cohen, the law professor at Drexel, told us the FDA could — and should — use its enforcement discretion, meaning it can say it isn’t going to enforce particular violations. Cohen equated the concept to law enforcement not having the resources to pull over everyone who drives 65 miles per hour in a 55 speed-limit zone, so they have to prioritize their resources.

“Law enforcement agencies are always using enforcement discretion … to say we’re going to go after the offenses that really matter,” he said in a phone interview. Similarly with unapproved drugs, the FDA focuses its efforts on drugs that aren’t effective or safe.

With mifepristone, the FDA could issue a notice saying it is using its enforcement discretion to not enforce the old requirements.

This is how the FDA initially allowed mifepristone to be distributed to patients through the mail during the COVID-19 pandemic, when there was concern about in-person office visits.

We spoke with Cohen before the appeals court ruling, but he said in Twitter posts after that decision that this concept still applies.

Another option would be for the FDA to expedite a new application for mifepristone, he told us, but that’s a lengthy process.

Will mifepristone be available despite the court rulings so far?

Yes, in states where abortion is legal. (Thirteen states have outlawed abortion, according to the New York Times’ tracking of such laws.) The appeals court said the FDA’s 2000 approval could stand, so if the 5th Circuit’s order goes into effect, the drug would remain on the market as an FDA-approved medication.

Barring an enforcement discretion notice from the FDA, as Cohen and others advocate, whether some of the pre-2016 restrictions on mifepristone will be followed could depend on the health care provider. Under the appeals court ruling, providers could prescribe mifepristone off-label beyond the seven weeks’ gestation and eliminate extra office visits, Cohen said in a tweet.

“Getting around the in person requirement is trickier,” Cohen said.

Greer Donley, a law professor at the University of Pittsburgh and a signatory of an amicus brief in the Texas case, said on Twitter that some telehealth “would still be allowed,” such as a telehealth appointment between a doctor in a big city and a patient who would pick up the medication from “satellite offices in smaller towns.”

And there are the 17 states, plus D.C., that are still under the Washington District Court order. The 5th Circuit’s ruling “should not impact anything in the 17 states + DC that are protected by the WA order unless SCOTUS says otherwise,” Donley said in another Twitter thread.

But in the other 33 states, “returning to the pre-2016 REMS will be a big deal,” she said. “In-person dispensing would shut down virtual clinics & overwhelm brick-&-mortar clinics. Abortion would be harder to access, less private & more expensive. Only doctors could prescribe.”

And the Comstock Act language in the appeals court ruling raises the possibility of criminal action against those who ship the pills, at least in a future Republican administration.

Even if the FDA doesn’t issue a statement saying it won’t enforcement the pre-2016 requirements, some providers “may decide that practically, the FDA is unlikely to target them under [President Joe] Biden,” Donley said.

Also, as the cases move forward, if patients can’t get mifepristone, medication abortion can continue by using only misoprostol, which is the protocol used in some other countries.

There are no lawsuits against misoprostol, Cohen said, and they would be difficult to pursue. The drug is FDA-approved to reduce stomach ulcers.

In addition, a group called Aid Access operates abroad and ships medication abortion pills from pharmacies in India to patients in the United States.

Are there broader implications if a court ultimately overrules an FDA approval?

The pharmaceutical industry and experts in health law have said that a court overruling the FDA approval of a drug would have repercussions beyond the abortion debate, potentially sparking lawsuits challenging other FDA-approved treatments and vaccines.

“If successful, this case could invite copycat lawsuits to limit other forms of politicized health care,” Donley, of the University of Pittsburgh, and Rachel Sachs, a law professor at Washington University in St. Louis and an expert in food and drug regulation, wrote in the Washington Post in early March. “Potentially at risk would be medications for a much larger range of indications,” they said.

Such a ruling also could affect research and investments in new drugs. “It could chill innovation nationwide,” Donley and Sachs said. “Manufacturers might become wary of investing time and money into products for a wide range of conditions which may — decades down the line — be the subject of nuisance litigation.”

More than 700 pharmaceutical and biotech industry executives and leaders expressed the same concern in a letter condemning Kacsmaryk’s April 7 ruling. “The decision ignores decades of scientific evidence and legal precedent,” they wrote. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” said the letter’s signatories, which included the CEOs of Pfizer and Biogen and leaders of Merck, Bayer and Bristol Myers Squibb.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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SciCheck Digest

Outside of long COVID or very severe cases, most research suggests COVID-19 doesn’t cause lasting damage to the immune system. A few studies have found evidence of some possible damage, but nothing as severe as an immunodeficiency. People on social media, however, are misinterpreting a recent study to incorrectly claim COVID-19 is HIV-like.

Full Story

COVID-19 can be serious and life-threatening. But in many cases, particularly if someone is vaccinated, the disease is mild. While there is a real risk of long COVID — lingering or new symptoms after infection with the coronavirus, which can sometimes be debilitating — most research suggests people who recover do just fine.

Studies show that most people who have been infected with the coronavirus, or SARS-CoV-2, are well-protected against severe disease if infected again, with subsequent or prior vaccination offering even more protection. 

There is no evidence that COVID-19 has left large swaths of the population immunocompromised or unable to fight off either the coronavirus or other pathogens.

Yet, as Slate has written, certain corners of the internet have misleadingly claimed that COVID-19 causes widespread immune dysfunction or immunosuppression that is leaving the entire population susceptible to all sorts of subsequent infections. In some cases, COVID-19 has incorrectly been likened to HIV/AIDS.

The latest versions of these scaremongering claims cite a recent paper from a lab at Stanford University and an accompanying press release from the National Institutes of Health. 

“New study (but not news to anyone paying attention) finds that COVID can damage the immune system in similar ways as HIV or Hepatitis,” one Twitter user wrote.

“What more do you want?” another Twitter user asked, sharing a screenshot from the press release. He continued: “how many times does it need to be shown? that’s the third study I’ve published TODAY showing this HIV like immune deficiency.”

Both the paper, published in the journal Immunity, and the news release do include statements that could seem to support some of these interpretations. But the senior author told us the comparison to other viruses had been misunderstood, and the immune defect his group identified is not so severe as an immunodeficiency. 

Some scientists are skeptical of the results, and say the study is an outlier.

“[T]here’s really no evidence … that SARS-CoV-2 infection causes long term immune damage similar to HIV or HCV,” E. John Wherry, an immunologist at the University of Pennsylvania, told us in an email, referring to hepatitis C virus. “These claims are not based on solid data – either rigorous immunological assessment or real world manifestation of increases in other infections or diseases related to immune suppression.”

COVID-19 Isn’t HIV-Like

The Immunity paper, which was published on March 15 and authored by Mark M. Davis’ lab at Stanford, analyzed T cells found in the blood of people after COVID-19 vaccination, SARS-CoV-2 infection or both.

T cells are one arm of the adaptive immune system. One subset, known as CD4 T cells, helps B cells make antibodies and helps coordinate the immune response. Another subset, known as CD8 T cells, kills infected cells to limit the spread of viruses.

Using a highly sensitive method to fish out coronavirus-specific T cells from hundreds of blood samples collected at multiple time points, the authors found that compared with people who had been vaccinated, people who had been infected had significantly reduced CD8 T cell responses against the coronavirus. Vaccination after an infection helped, but the CD8 T cell response was still much lower than in those who had never been infected.

“This suggests that SARS-CoV-2 virus infection may cause long-term damage to the patients’ immune system well after viral clearance,” the authors wrote.

In their discussion, the authors made a comparison to infection with HIV and hepatitis C virus, noting that reduced CD8 T cell function has been observed in patients as long as a year after those viruses were either fully or nearly eliminated. This comparison was then highlighted in an NIH press release, which people on social media then quoted to lend credence to the false idea that COVID-19 is HIV-like.

But the authors’ comparison is specific to a particular phenomenon with those viruses and their effects on CD8 T cells after total or near-total viral clearance. It doesn’t mean COVID-19 causes an immunodeficiency on par with HIV, which permanently damages the immune system by killing off a person’s CD4 T cells.

“The damage we cited in our paper was more subtle,” Davis told us — “not on the same scale as the CD4 wipeout for HIV.”

In fact, the Stanford group found no noticeable differences in the CD4 T cells from people who had been infected versus not.

As Danny Altmann, a professor of immunology at Imperial College London, told us, the “immune effects of Covid are nothing like HIV at all.”

While the comparison was misunderstood, some scientists criticized the authors for making it.

“The scale of the defect in HIV and HCV is so much greater that I think anything that’s being reported here — even if we take it at face value — that I think that was a … risky analogy to make,” Paul G. Thomas, an immunologist at St. Jude Children’s Research Hospital, said in a phone interview. “I think that’s caused a lot of alarm and a lot of frantic press speculation that’s really not warranted.”

Immunity Paper

A few scientists we spoke with were also doubtful of the Immunity paper’s results and critical of how the group interpreted its findings.

Thomas, who published a paper in Nature Immunology in April 2022 that did not find any CD8 T cell defects, emphasized that the Stanford paper is just one of many other studies from groups using a variety of techniques that have come to opposite conclusions.

“It’s not particularly representative of what many, many other studies have found, which have suggested that if you had a mild to moderate COVID infection, you’ve recovered, you don’t have long COVID,” he said, “then you should not be worrying about anything.”

Wherry, the Penn immunologist, said the Immunity paper was “definitely an outlier.”

“Most if not all other studies that have examined this issue carefully find the opposite or fail to come to the same conclusion. In fact, for what they specifically examined: infection followed by vaccination – there’s a lot of data that this ‘hybrid immunity’ is good,” he said in an email. “Moreover, these individuals are not more susceptible to SARS-CoV-2 or anything else for that matter. There’s no evidence of immune system damage.”

In most cases, Thomas explained, people with a mild to moderate COVID infection mount a standard immune response, and generate good immunological memory to the virus, similar to what happens with influenza. Vaccination on top of infection typically boosts “some aspects of that memory response,” he said.

There are exceptions when there are problems with the immune system. People who have had very severe COVID-19 do sometimes have very low counts of T and B cells, for example. And with long COVID, there could be other immune problems, although those still wouldn’t be considered a full immunodeficiency.

“In long COVID there is likely some immune perturbation,” Wherry said, “but exactly how that works has not been clearly defined yet.”

Several possibilities might explain the Stanford group’s results, Thomas said, including the chance sampling of an outlier group of people, or the methods that the lab used. The lab used a unique approach for identifying the specific T cells.

Thomas also said that based on what was written about the methods, it seemed patients were drawn from different studies, so it’s possible the blood samples might have been processed in slightly different ways.

The authors themselves note in the paper that, as is true with other similar studies, it’s impossible to capture the full range of T cells that recognize the coronavirus, and their analysis was limited to the cells circulating in the blood. If more virus-specific CD8 T cells stayed localized in tissues after infection compared with vaccination, that would affect the results.

Wherry said he had “serious concerns” about some of the lab’s methods, which include a technique not used by others in the field. He also thought the paper’s stated conclusions were “an over interpretation of what the data in the paper show.”

“Bottom line,” he said, “is that others don’t see this.”

Davis, however, defended his work.

“The other studies were one-tenth the sensitivity of our study,” he said in a phone interview. “Which doesn’t completely explain why they didn’t see this, but we saw what we saw, and it would be irresponsible if we didn’t publish it.”

Davis said he thinks his results “reflect some kind of long-term damage,” which might relate to long COVID. It is not yet clear what this entails or how it would manifest, he said, but one idea is that people could have a harder time recovering after a reinfection.

While his paper suggested that the damage could apply to other infections, Davis said he thinks it’s likely to be specific to the coronavirus. That mention was included, he said, because the authors couldn’t rule out a broader effect, since they hadn’t tested for that yet. The data in his paper, however, only show a diminished response from CD8 T cells that recognize SARS-CoV-2.

Davis said the main message for the public should not be fear, but to get vaccinated, since vaccination helped improve the impaired CD8 T cell response following infection. But he said he hopes scientists are spurred to investigate the phenomenon further. 

“I think everybody’s got to look at this and dig deeper and see what this might mean,” he said.

Other scientists weren’t as critical of the Immunity paper. Altmann, of Imperial College London, said in an email that the study was from “a superb and reliable lab, and their answers stand.” He added that the work is “somewhat similar” to another paper published in January 2022 in Nature Immunology, which identified immune system differences the authors termed “immunological dysfunction” eight months after mild-to-moderate infection.

However, Altmann noted that other “equally excellent research,” published in Nature in January, came to the opposite conclusion, finding that males who had recovered from mild COVID-19 actually had better responses to a flu vaccine than those who never had COVID-19.

He cautioned against reading too much into any single dataset, particularly when research on COVID-19 has quickly outstripped that of any other disease.

Regardless, scientists said it was incorrect to conclude from the Immunity paper or anything else that COVID-19 causes something as extreme as an immune deficiency.

“[T]here are some nuanced differences for some T cell markers in some studies, but this [isn’t] remotely the same as immune compromise and currently, unlinked to any phenotype,” Altmann said, referring to any observable effect.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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The post Posts Exaggerate Lab Findings About COVID-19’s Impact on Immune System appeared first on FactCheck.org.

SciCheck Digest

A folic acid supplement is recommended during pregnancy and prior to conception because it reduces the risk of neural tube defects in babies. Social media posts have claimed that people should avoid folic acid in favor of a different form of the vitamin, but folic acid is the only one that has been established to help prevent birth defects.

Full Story

Neural tube defects affect the spinal cord and brain. They occur very early in pregnancy when the neural tube doesn’t close properly. The most common types are spina bifida, a defect of the spine that can range from having little impact to causing intellectual disability or paralysis, and anencephaly, a fatal defect in which parts of the brain and skull do not form.

Taking a folic acid supplement prior to and during pregnancy — first broadly recommended in the U.S. in 1992 — can reduce the risk of these birth defects. The rate of neural tube defects fell in the U.S. after the government mandated in 1998 that certain grain products be fortified with folic acid.

Folic acid is a form of folate, or vitamin B9. Folate helps the body with basic functions such as making DNA, which is necessary for cells to replicate.

Widely shared social media posts incorrectly claim that people should not ingest folic acid, particularly those who have a certain common gene variant.

“Folic acid is not a physiological active form of folate. It doesn’t do anything good,” one recent post stated, recommending that people take other folates. “If you have the mthfr gene mutation, avoid folic acid!” said another. People have made similar claims on multiple accounts over several years.

There is a common variant of the MTHFR gene, particularly prevalent in Hispanic individuals, that slightly reduces the body’s ability to process folic acid. But people with this variant can still process folic acid and should take folic acid supplements at the usual dose, according to the Centers for Disease Control and Prevention website.

Prenatal supplements that contain a different type of folate, often a stabilized version of 5-methyltetrahydrofolate, or 5-MTHF, are increasingly available. As with folic acid, taking 5-MTHF increases folate levels in the blood, so it could have a similar impact in theory. But folic acid “is the only type of folate shown to help prevent neural tube defects,” the CDC says.

And when taken within the recommended amounts, folic acid doesn’t have any known health risks, a CDC spokesperson told us via email, contrary to claims in some social media posts.

“Is having another form of folate adequate? We don’t know because the studies have not been done,” Dr. Shannon Clark, a professor of maternal-fetal medicine at the University of Texas Medical Branch in Galveston, told us. Such a study, comparing folic acid to another form of folate prior to conception and in early pregnancy, would likely never be approved due to ethical reasons, she said.

“There are no clinical trials using 5-methyltetrahydrofolate as a substitute for folic acid to prevent birth defects,” said Patrick Stover, a metabolic biochemist and director of the Institute for Advancing Health through Agriculture at Texas A&M University. “That doesn’t mean it shouldn’t work, but it’s never been tested. … So likely it could be a substitute, but it’s never been tested, and it would be unethical to test it because there’s already a solution.” That solution, he explained, is consuming folic acid.

A wide array of government and expert organizations recommend that people who could get pregnant consume 400 micrograms (mcg) of folic acid daily. The U.S. Preventive Services Task Force — an independent group of experts on preventive medicine — recommends 400 to 800 mcg per day. 

The organizations vary on whether the recommended amount of folic acid, a synthetic folate, is limited to supplements or refers to fortified foods and supplements combined. Some guidelines specify that people should make sure to get 400 mcg folic acid on top of eating a generally healthy diet with naturally occurring folate.

Expert groups representing physicians who treat pregnant people specify that folic acid supplementation should start at least a month prior to conception and continue through pregnancy week 12, since the neural tube is formed very early in pregnancy.

There are separate folate recommendations for people who aren’t pregnant or soon-to-be pregnant.

“For the general population there isn’t any recommendation from public health authorities about the folate versus folic acid versus [5-MTHF],” said Carol Haggans, a registered dietician and scientific and health communications consultant with the Office of Dietary Supplements at the National Institutes of Health. She noted that this group should focus on getting folate from food.

People With MTHFR Gene Variant Can Process Folic Acid

The MTHFR gene tells the body how to make an enzyme that processes folate. The enzyme helps perform a step on the path to turning folic acid into 5-MTHF, a form of folate that is active in the body. 

As we said, some people have a variant of MTHFR that differs from the most common type. Expert organizations do not recommend routine testing for MTHFR variants.

The most common MTHFR variant is MTHFR C677T, and approximately a quarter of people who are Hispanic, 10% of those who are white or Asian, and 1% of African Americans have two copies of this version of the gene. The variant is found at an even higher rate in some groups — reaching greater than 35% prevalence in people of Mexican or northern Chinese descent.

People with two copies of this MTHFR variant have about 16% lower amounts of folate in their blood on average than people with two copies of the predominant version after consuming the same amount of folic acid. People with one copy of the variant also have reduced blood folate, but to a lesser degree.

This is not enough of a reduction that people with the variant need to follow different instructions on supplementation. “Consuming 400 mcg of folic acid each day helps prevent neural tube defects, even if you have an MTHFR C677T variant. Taking a supplement with more than 400 mcg of folic acid each day is not necessarily better for preventing a neural tube defect,” the CDC says. 

People who have previously had a baby with a neural tube defect or who have certain health conditions may be recommended to take more folic acid.

Folic Acid Versus Other Folates Like 5-MTHF

In recent years, the folates present in some prenatal supplements began to change, according to an analysis published in 2020 by researchers from the National Institutes of Health. 

Between September 2015 and March 2019, 32% of prescription and a quarter of nonprescription prenatal supplements included in NIH databases contained stabilized salts of 5-MTHF, said Haggans, who co-authored the report. Prior to September 2015, no supplements in the databases reported having salts of 5-MTHF.

Our recent Google search for the “best prenatal vitamins” turned up best-of lists where the majority of listed supplements have other folates instead of folic acid.

Like other vitamins and supplements, prenatal supplements are not approved for efficacy and safety by the Food and Drug Administration before companies can market them. Supplements do not have to contain particular vitamins and minerals to be marketed as prenatal, and their content varies.

When asked via email if the increasing prevalence of 5-MTHF in prenatal vitamins is a public health concern, the CDC told us: “Yes. Currently there is only research to support the use of folic acid to prevent neural tube defects. No scientific studies exist that show that supplements containing other types of folate (such as 5-MTHF) can help prevent neural tube defects. Therefore, we do not know if prenatal vitamins with 5-MTHF offer the same level of protection against neural tube defects as those with folic acid.”

Studies do show that taking 5-MTHF increases the concentration of folate in the blood. However, CDC scientists wrote in a review paper that to establish efficacy of 5-MTHF in preventing neural tube defects, there would need to be a randomized trial demonstrating that it was safe and effective and establishing the proper dose and timing.

Stover pointed out that 5-MTHF has two downsides. The first is that it is much more expensive to make than folic acid. The second is that 5-MTHF is less stable. This leads to concern that the level of intact folate found in some supplements at the time they’re consumed could differ from the amount listed on the label. Newer forms of 5-MTHF have improved stability, he said, but “it does not achieve the stability of folic acid.” 

Someone could theoretically aim to get the equivalent of 400 mcg folic acid only from eating a healthy diet rich in natural food folate. However, getting this amount of folate from unfortified foods alone “requires consumption of a large quantity of foods not typically consumed,” the CDC scientists wrote in the review. “For example, a person would need to consume approximately 12 cups of raw spinach daily to reach the recommended level.” 

Further, the researchers wrote, studies haven’t determined how much natural food folate is needed to reduce neural tube defects or how it interacts with other vitamins, “so it is not possible to recommend an intake of natural food folate that is certain to prevent [neural tube defects].”

Social media posts bring up that folic acid “doesn’t exist in nature” or “doesn’t occur anywhere naturally.” Indeed, it is a synthetic folate used in supplements and for food fortification due to its relative stability in the presence of heat and light compared with folate naturally found in food. (Folic acid only occurs in nature in trace amounts, Stover explained.) 

But 5-MTHF supplements are also not the same as natural food folate. The folate found naturally in food is less bioavailable — meaning it’s less easily absorbed and used by the body — than either folic acid or 5-MTHF supplements.  

“Just because something isn’t found naturally in food in high concentrations doesn’t mean it’s harmful,” Stover said.

How to Look for Folic Acid on Supplement Labels

The FDA does require supplements to have a “supplement facts” label including a list of dietary ingredients and the amount per serving.

Supplement labels can cause confusion, Haggans said, because folate is measured in various ways. The FDA requires that labels have in parentheses the mcg of folic acid to aid people who are trying to prevent neural tube defects.

“The number to look for is the number in parentheses,” Haggans said. 

And again, experts generally recommend 400 mcg of folic acid for people who could become pregnant. 

The parenthetical value should specify that it is talking about folic acid — some supplement makers include a number in parentheses referring to the mcg of other folates. These are usually versions of 5-MTHF, which is sometimes also referred to as L-5-MTHF or methylfolate.

“If the supplement label does not specifically say folic acid in the parentheses then it does not have folic acid,” Clark said.

No Known Risks From Recommended Levels of Folic Acid

Folic acid is safe when taken as recommended. “Folic acid taken at or up to the recommended amount of 400-800 micrograms per day (mcg/day) has not been shown to be harmful,” the CDC spokesperson told us. 

The tolerable upper intake level for folate from fortified food or supplements in adults, including pregnant people, is 1,000 mcg daily, according to the Institute of Medicine, which provides these numbers to indicate the level under which a nutrient is unlikely to pose any health risks to “almost all individuals in the general population.”

One-third of U.S. pregnant women are estimated to consume amounts of folic acid from fortified foods and supplements that put them over the tolerable upper intake level, according to a 2019 study published in JAMA Network Open.

The limit was established because of concern that folate at high levels — over 5,000 mcg daily — could cause a B12 vitamin deficiency to go undiagnosed, leading to potential neurologic complications. The theory was that consuming high levels of folic acid could improve a type of anemia resulting from low B12 without correcting other problems associated with the deficiency. People of reproductive age have a low rate of B12 deficiency, especially compared with older adults.

However, the CDC spokesperson noted that people who have low B12 are unlikely to get as much benefit from 5-MTHF as from folic acid because “5-MTHF needs vitamin B-12 to work in the body, while folic acid can work without this vitamin.”

Some supplement companies argue that 5-MTHF is safer because when folic acid is not fully metabolized, it can circulate in the blood. But harms from circulating folic acid have not been established, Stover said. “That’s not an adverse effect. It just shows you’ve saturated the system,” he said. “It’s circulating. It’s not known to have any activity or function when it’s circulating.” Excess folic acid is eventually excreted in urine.

A separate possibility is that elevated folate status in general could have some negative impact, Stover said, meaning there could be some consequence to having large amounts of folate in the body no matter the type. Someone could have elevated folate status regardless of what form they consumed, he added.

But, observations that indicate elevated folate levels in the body or excess folic acid intake can have negative health impacts — mainly from animal and nonrandomized studies — are inconclusive, Stover and his colleagues wrote in a summary paper.

Still, “you should never take more than is recommended is the bottom line,” Stover said. “More isn’t always better, but you don’t want to be deficient.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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The post Taking Folic Acid, Not Other Folates, Is Recommended to Reduce Risk of Birth Defects appeared first on FactCheck.org.

Nearly all children get sick from respiratory syncytial virus, or RSV, by the age of 2, and last year, there was a notable surge in RSV-associated hospitalizations. But the Food and Drug Administration is now considering approval of a vaccine and a monoclonal antibody aimed at protecting infants from this common virus. We’ll explain what we know so far about these medical products and the risks of RSV for young children.

RSV circulates in colder weather and causes a mild cold in most people. But infants and older adults can experience serious and dangerous illness. As we explained in a companion story, several potential vaccines for older adults are in the works, including one from Pfizer and another from GSK that could get a decision from the FDA in a few months.

Pfizer’s vaccine also has been administered to pregnant people in a clinical trial to determine whether the antibodies they develop in response to vaccination can then protect their babies up to 6 months of age. The company has applied for FDA approval for that use as well. Meanwhile, Sanofi and AstraZeneca have asked the FDA to approve a monoclonal antibody injection for newborns and infants, which, while not a vaccine, would act like one in preventively protecting babies from RSV illness.

As we’ve reported, children’s hospitals across the country were at full capacity last fall due to a spike in RSV infections. But scientists have been working on ways to prevent the illness for decades, and the current crop of candidates is due to scientific advances in 2013.

We don’t know if the products — both those for older adults and those for infants — will be approved by the FDA. But if they are, they could be available for the next RSV season this fall.

What is RSV illness in children, and why are these products being proposed now?

Nearly all children will get RSV, which typically circulates in the fall and winter, by the time they’re 2 years old, the Centers for Disease Control and Prevention says. While the virus causes cold-like symptoms, including runny nose, cough and fever, babies younger than 6 months old may only exhibit difficulty breathing, irritability and a reduction in activity or appetite.

Young and premature babies and infants with heart or lung disease, or weakened immune systems, are particularly susceptible to severe infection due to RSV. The virus is the leading cause of pneumonia and bronchiolitis — infection and inflammation of the lungs, respectively — in kids younger than 1, the CDC says.

The CDC estimates that 58,000 to 80,000 children under 5 years old are hospitalized each year because of RSV and that among every 100 babies under 6 months of age with RSV, 1 to 2 may need hospitalization. Deaths are “uncommon,” in the U.S. the CDC says, at an estimated 100 to 500 each year for kids under 5.

Worldwide, an estimated 45,700 babies up to 6 months of age died due to RSV in 2019, and more than 100,000 children up to age 5 died, according to a systematic analysis of hundreds of studies published in the Lancet. The researchers said that “more than 97% of RSV-attributable deaths across all age bands were in low-income and middle-income countries.”

As we explained in our story on the older adult vaccine candidates, the search for a safe and effective vaccine began many years ago. The field got off to a bad start when a trial testing an inactivated RSV vaccine for young children in the 1960s backfired. Instead of preventing infections or illnesses, the vaccine, which was made from killed virus, made infections worse. Vaccinated kids developed more severe disease than those who were unvaccinated when they were infected with RSV for the first time, and two infants died.

Nearly 50 years later, scientists had a breakthrough. In research published in the journal Science in 2013, they stabilized the pre-fusion form of the virus’s F protein — the protein the virus uses to enter human cells — and found that it sparked highly protective antibody responses in animals. The discovery came from a team at the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.

Once the F protein fuses with cells, it changes into a post-fusion form, and targeting that post-fusion form, as some other vaccine candidates have done, produced a much lower immune response.

The vaccine and antibody candidates we’re seeing now target the pre-fusion F protein, building on that fundamental work by the NIH.

What are the potential vaccines for pregnant people?

In February, the FDA accepted Pfizer’s application for its maternal vaccine candidate.

The vaccine is the same formulation as Pfizer’s vaccine for older adults, but it would be given to pregnant people in order to pass antibodies on to babies to protect them from birth to at least 6 months of age. Pfizer expects a decision from the FDA in August.

“Starting immunization in the second trimester of pregnancy, protective antibodies are naturally passed from the mother’s circulation across the placenta and to the developing fetus,” Pfizer told us in an email. “Maternal immunization takes advantage of this natural process, resulting in infants having maternally derived protective antibodies at levels similar to or even higher than their mother.”

The vaccine is a protein subunit vaccine — like the hepatitis B and pertussis vaccines. It is made from pre-fusion F protein from RSV-A and RSV-B, subgroups of the virus; the pre-fusion F protein prompts an immune response but can’t cause RSV disease.

GSK also developed a protein subunit vaccine for older adults, and it was testing a nearly identical version for pregnant people. But in February 2022 GSK voluntarily stopped its clinical trials due to a safety signal: an imbalance in preterm births that it is investigating. (See below for more on this.) Unlike the older-adult version, the maternal vaccine doesn’t include an adjuvant, which boosts immune responses.

The older-adult vaccines are further along in the FDA approval pipeline. The FDA’s outside advisory group — the Vaccines and Related Biological Products Advisory Committee — has already met to discuss them.

What is the antibody for infants?

Sanofi and AstraZeneca have developed a monoclonal antibody, nirsevimab (pronounced nur-SEV-i-mab), to be administered as a single-dose shot to newborns or infants before their first RSV season to protect against RSV illness. The drug, which has the brand name Beyfortus, was already approved by the European Commission last fall.

Sanofi says it expects a decision from the FDA in the third quarter of this year.

Monoclonal antibodies are lab-produced antibody clones that mimic the actions of natural antibodies in preventing disease — in this case, nirsevimab targets the pre-fusion F protein of RSV.

“As a monoclonal antibody, nirsevimab does not require the activation of the immune system to help offer timely, rapid and direct protection against disease,” a Sanofi spokesperson told us.

Babies 11 pounds or more would receive the full 100 milligram dose, while smaller babies would receive a half dose.

There is another monoclonal antibody on the market to prevent RSV illness in infants, but it’s only recommended for some premature babies or high-risk children. The drug, palivizumab (pronounced pal-i-VIZ-oo-mab), with the brand name Synagis (SIN-uh-jis), is administered monthly during the RSV season, typically for five months. It was approved by the FDA in 1998, after a clinical trial showed a 55% risk reduction for RSV-associated hospitalization for infants who were born prematurely or children with chronic lung disease.

The idea of giving palivizumab to all infants “never had any real traction,” Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and also a professor of preventive medicine and infectious diseases at the Vanderbilt University School of Medicine, told us. The level of effectiveness of the drug is beneficial to high-risk children, but it “wasn’t sufficient,” particularly when the treatment required multiple injections, to give to all infants.

Preterm infants are also at the highest risk of developing bronchiolitis or a very severe RSV infection, he said.

Nirsevimab appears to be more effective in reducing hospitalization, even in full-term infants — more on this below — and only requires one injection. Schaffner noted that while the drug manufacturers hope nirsevimab will be offered universally to all infants, it remains to be seen what recommendations the CDC’s Advisory Committee on Immunization Practices and the American Academy of Pediatrics will make to pediatricians.

On Feb. 23, a maternal/pediatric RSV work group for the CDC’s ACIP presented its findings on nirsevimab, saying the work group would recommend the antibody for all infants in their first RSV season — at birth for those born in October to March and before the RSV season for other babies up to 8 months of age. A child’s first RSV infection is typically the worst.

In a child’s second RSV season, the work group favored recommending nirsevimab for high-risk children eligible for palivizumab, because it would be cost-effective. But the work group said it would need more time to consider which children would be at sufficiently high risk to receive the drug in their second season.

These recommendations are not the final word from the CDC, but rather feedback from the work group. If the FDA approves nirsevimab, the entire advisory committee will vote on these policy questions.

What do we know about the efficacy and safety of Pfizer’s vaccine?

The FDA’s advisory committee hasn’t discussed this vaccine; however, Pfizer’s Dr. Iona Munjal, senior director of vaccine research and development, presented data from a phase 3 clinical trial to the CDC’s ACIP on Feb. 23. (For more on the FDA approval process and clinical trial phases, see this graphic.)

The phase 3 study began in June 2020, enrolling nearly 7,400 pregnant participants in 18 countries, with half receiving the vaccine and half getting a placebo. Nearly all participants got the vaccine or placebo at 24 to 36 weeks gestation. The average age of the mothers was 29.

Among the infants, 7,128 continued with the study. About half were enrolled in the first year and are being followed for 24 months. The rest are followed for one year.

The study showed a vaccine efficacy of 81.8% against severe RSV-confirmed lower respiratory tract illness requiring a medical visit in the first 90 days after birth. Efficacy was 69.4% through 180 days after birth.

Efficacy is a measure of reduced risk for those receiving vaccination, compared with those who aren’t vaccinated.

Severe illness in the study was defined as at least one symptom including tachypnea, or rapid breathing; low blood oxygen; mechanical ventilation or supplemental oxygen therapy; or ICU admission for more than four hours or being unresponsive/unconscious.

There were 63 hospitalizations due to RSV up to 180 days after birth — 19 in the vaccine group and 44 in the placebo — for an efficacy in preventing hospitalization of 56.8%.

In terms of safety, Munjal said there were no serious adverse events deemed to be related to vaccination. Mothers reported common, mild or moderate vaccine side effects. Nearly 41% in the vaccine group reported pain at the injection site within a week of vaccination; nearly 27% reported muscle pain; 31% reported headache, which was slightly higher than the incidence in the placebo group.

There was no statistically significant difference between premature births, low birth weight or other reported events for infants within one month of birth. Premature births overall in the trial were low: A little over 5%, compared with a background rate of 10% of all births globally that are premature, Munjal said.

The few deaths and fetal losses among participants were unrelated to the study, as determined by the investigator leading the study and Pfizer. Munjal noted that an “external data monitoring committee” reviews all of the safety information in the trial and that any deaths associated with any respiratory illness are reviewed by an “external adjudication committee.” There was one maternal death in the vaccine group and zero in the placebo group. Fetal deaths and stillbirths were “rare” (10 in the vaccine group, eight in the placebo), Munjal said, and lower than background rates. There was one infant death associated with RSV illness, and it was in the placebo group.

In answering questions from ACIP members, Munjal said the trial had “a slightly more healthy population” than the general pregnant population at large, because participants self-selected. Therefore, there was a lower risk of prematurity. A screening ultrasound was required, and if congenital defects were detected, those pregnant people were excluded from the study.

The ACIP work group on RSV maternal/pediatric medical products will now consider the policy question of whether the Pfizer maternal vaccine should be recommended for all pregnant people at 24 to 36 weeks gestation. The work group will present its findings at a June meeting, and the full ACIP board could vote on such recommendations in October — if the vaccine is approved by the FDA by then.

Update, April 6: Pfizer’s phase 3 trial results were published in the New England Journal of Medicine on April 5.

Update, May 17: The FDA released its briefing document on the Pfizer vaccine in preparation for the May 18 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

The briefing document said the “safety data appear generally favorable for vaccine administration,” but the FDA noted a “numerical imbalance of 1%” in premature births. FDA said the difference was not statistically significant but indicated the imbalance could be discussed by the advisory committee.

One premature birth was assessed to be “possibly related” to the vaccine. The infant had “a normal birth outcome and no complications,” the FDA said.

In the case of one infant death, due to complications of preterm birth, the FDA said it was “unable to exclude the possibility” that the prematurity and death were related to the vaccine.

The advisory committee will vote on whether the data support the safety and efficacy of the vaccine in preventing RSV-confirmed lower respiratory tract illness and severe cases of the illness. In terms of preventing all medically attended cases of RSV, the trial data found an efficacy of 51.3% at 180 days after birth.

Update, May 18: VRBPAC, the FDA advisory committee, voted unanimously, 14-0, that the data supported the effectiveness of the Pfizer maternal vaccine in preventing RSV lower respiratory tract disease and severe disease in babies from birth to age 6 months. The vote was 10-4 in favor of the data supporting the safety of the vaccine.

Those who voted no expressed concern about the data not providing enough certainty on whether the imbalance in preterm births was a safety issue. Dr. Paul A. Offit, a vaccine expert and pediatrician at the Children’s Hospital of Philadelphia, posed the question of whether the data was “adequate in terms of reassuring one that what was seen with GSK’s vaccine is not going to be seen here.” Offit said, “If you’re in any sense risking premature births with this vaccine, I think there’ll be a big price to pay, and so I guess I just don’t feel we have enough data to be reassuring.”

Others who voted yes said the difference in preterm births wasn’t statistically significant.

Dr. Jay M. Portnoy, a pediatrician at Kansas City’s Children’s Mercy Hospital, also talked about the dangers of RSV for very young infants. “So if I compare the very small risk of earlier birth with the almost certain risk of getting RSV and a very high risk of ending up in the hospital, I have to on balance say that the risk is much greater if we don’t give the vaccine then if we do, so that’s why I voted yes,” he said.

The FDA will now consider whether to approve the vaccine.

What about the safety and efficacy of the monoclonal antibody?

Results from phase 3 and 2b clinical trials of Sanofi and AstraZeneca’s monoclonal antibody nirsevimab were published in January in the Lancet Child & Adolescent Health journal.

The pooled results from those trials, which included infants born at 29 weeks through full term, showed 79.5% efficacy in preventing RSV lower respiratory tract illness requiring medical attention for up to five months, which would be one RSV season. (There were 19 such cases in the vaccine group and 51 in the placebo.) In the trials, vaccination lowered the risk of hospitalization by 77.3% and the risk of “very severe” RSV by 86%.

Updated phase 3 data, presented at an RSV international conference in Portugal in late February, showed efficacy rates above 76% for preventing each of those three outcomes. The phase 3 trial includes 3,012 infants in more than 20 countries born at 35 weeks gestation or more, with nearly 2,000 of them receiving nirsevimab and the rest getting a placebo. (See page 18.)

Trial results assessing the safety of nirsevimab were published in three articles in the New England Journal of Medicine in 2020 and 2022. For preterm, late preterm and full-term infants, reports of adverse events up to 360 days after the injection were similar between the treatment and placebo groups, and no serious adverse events, including a small number of deaths, were related to the trial, according to investigators.

There were no serious allergic reactions to the treatment. A few infants developed rashes that were considered to be related to the injections.

In assessing the use of nirsevimab compared with palivizumab for preterm infants or those with heart or lung disease, researchers concluded that the two drugs had a similar safety profile. They found that reported adverse events were “similar across treatment groups and cohorts.”

Why did GSK stop its trial of a maternal vaccine?

GSK announced in February 2022 that it had voluntarily halted the clinical trials of its maternal vaccine due to an observed safety signal by an independent monitoring committee. That signal was “an imbalance in the proportions of preterm births and neonatal deaths between the vaccine and the placebo groups,” in a phase 3 trial being conducted in 24 countries, as explained in an abstract of research discussed at the international conference held in Portugal this February on RSV preventions and treatments (see page 60).

“We are still investigating the cause of the safety signal and, currently, do not have a mechanistic explanation for it,” a GSK spokesperson told us.

The imbalance “was more associated with low- and middle-income countries,” the abstract said, showing a 57% higher risk of preterm birth for vaccine recipients in such countries compared with the placebo group, and only a 4% higher risk, which wasn’t statistically significant, among vaccine recipients in high-income countries.

“The preterm birth imbalance peaked from August to December 2021 and was not observed consistently from January 2022 onward,” it said. The GSK spokesperson told us the full findings will be published in a peer-reviewed journal, but there’s no timeline for that.

The abstract showed that among 3,496 maternal vaccine recipients, nearly 7% had a preterm delivery, defined as less than 37 weeks’ gestation. Among the 1,739 participants in the placebo group, 5% had a preterm delivery. A full-term pregnancy is 39 weeks.

Those preterm birth rates are below the global background rate of about 10%. These figures vary by country, with 5% to 18% of births occurring preterm, according to the World Health Organization.

In a presentation at the February conference, Ilse Dieussaert, GSK’s vice president of vaccine development, said that the safety signal was observed in one clinical trial but not in others GSK was conducting for the RSV vaccine in pregnant women.

She noted that the imbalance in neonatal deaths was only present for preterm births, not births that occurred at 37 weeks or later. Additionally, Dieussaert said, based the clinical information on each of the neonatal deaths, “we concluded that the events leading to the death of the infants are those that are most commonly observed in premature babies and the complications of being born prematurely.” So, the neonatal death imbalance “is considered to be a consequence of the preterm imbalance” and “is not considered to be an independent safety signal.”

The GSK spokesperson also said the investigation doesn’t affect the phase 3 trial for the older adult RSV vaccine.

In a statement sent to FactCheck.org, Phil Dormitzer, head of vaccine R&D at GSK, said: “We continue to work with study investigators to ensure the best care possible for the women and children involved. These initial findings may be useful for understanding the risks and benefits of RSV maternal immunization more broadly. We continue to collect data and further analysis is ongoing. We are committed to share updates as they become available.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Q&A on RSV Maternal Vaccine and Antibody Candidates to Protect Infants appeared first on FactCheck.org.

Update, May 4: The FDA approved GSK’s vaccine, Arexvy, for adults age 60 and older on May 3.

Update, June 1: The FDA approved Pfizer’s vaccine, Abrysvo, for adults age 60 and older on May 31.

This year, the Food and Drug Administration will consider several applications for vaccines and a monoclonal antibody to prevent respiratory syncytial virus, or RSV, illness. The common virus causes a mild cold in most people, but infants and older adults can experience serious and dangerous illness.

The vaccines and preventive antibody are aimed at those populations.

As we reported last fall, an early surge of RSV infections led to full capacity at children’s hospitals across the country, so the disease — and finding a way to prevent it — may be top of mind for many parents of young children. But the pursuit of a safe and effective vaccine has been decades in the making, and the recent promising candidates are due to a scientific breakthrough in researching how the virus infects cells.

While these medical products have not been approved by the FDA yet — and we can’t say exactly when or whether they will be — they are moving through the application process. If greenlighted, they could be available for the next RSV season this fall.

Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a professor of preventive medicine and infectious diseases at the Vanderbilt University School of Medicine, told us that with these candidates, we’re “on the threshold of being able to really make an impact on RSV both in infancy and in adults.”

We’ll go through some common questions about RSV and the potential vaccines for older adults in this story. In a second article, we’ll address the vaccine candidates for pregnant people, and the monoclonal antibody candidate for infants.

What is RSV?

RSV causes cold-like symptoms, including runny nose, coughing, sneezing, fever, wheezing and loss of appetite, according to the Centers for Disease Control and Prevention. Infants younger than 6 months may only exhibit difficulty breathing, irritability and a reduction in activity or appetite.

It’s typically a colder-weather virus, circulating in the fall and winter.

Throughout a lifetime, a person can be reinfected with RSV “quite often,” Dr. H. Keipp Talbot, an infectious diseases expert at Vanderbilt University, said during a presentation on RSV immunity before the FDA’s Vaccines and Related Biological Products Advisory Committee on Feb. 28. The committee — VRBPAC for short — met over two days to discuss two vaccine candidates for older adults.

Immunity acquired from an infection “does not provide durable or complete protection from reinfection,” Talbot, who is also a member of an advisory committee to the CDC, concluded, after explaining the research from several studies. Another case of RSV can occur within two months of a person’s last infection.

For most people, the disease is mild, and they’ll recover within two weeks. But infants and older adults, particularly those with heart and lung disease, weakened immune systems, or premature and young babies are at higher risk of developing a severe infection and needing to be hospitalized.

Schaffner told us there’s a need for a lot of education on the virus and that’s particularly the case for the risks for older adults. He said the vast majority of physicians caring for older adults were taught that RSV is a pediatric virus and information on the impact on the older adult population developed over the last 10 to 15 years.

For adults age 65 and older, the CDC estimates, based on a several studies and its own surveillance data, that there are 60,000 to 160,000 hospitalizations due to RSV per year and between 6,000 and 10,000 deaths. Dr. Fiona Havers, the lead of the CDC’s hospitalization surveillance team for coronaviruses and respiratory diseases, presented this data at the Feb. 28 VRBPAC meeting, noting that the wide ranges show there’s “substantial uncertainty” about the disease burden and that the upper ranges could be higher, because RSV testing isn’t often done.

For comparison, influenza is associated with 128,000 to 467,000 hospitalizations and 16,000 to 43,000 deaths each year among adults 65 and older, according to the CDC.

There isn’t a “quick, accurate and relatively inexpensive” RSV test for use in doctors’ offices, Schaffner said. Testing is mostly done in research studies and in hospitals, where it’s expensive and done as part of a test looking for multiple viruses at the same time.

Havers said those 80 and older have much higher rates of hospitalizations for RSV, at 237 to 325 hospitalizations per 100,000 people, three to nearly four times higher than the rates for 65- to 69-year-olds, according to the CDC data, which relies on information from a network of hospitals in 12 states.

Why are there several potential vaccines now?

Scientists have been working on vaccines for RSV for decades.

In the 1960s, a clinical trial testing an RSV vaccine for infants made with inactivated virus — the same method used for the flu and hepatitis A vaccines — found that it didn’t stop infections, and vaccine recipients had more severe illness when they later contracted RSV than infants in the control group. Two infants, ages 14 and 16 months, died.

It wasn’t until scientific research published in the journal Science in 2013 that the outlook for viable RSV vaccines changed considerably. A team of scientists at the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, were able to stabilize the pre-fusion form of the virus’s F protein — the protein the virus uses to enter human cells — and determined through animal testing that immunization with variants of this pre-fusion F protein sparked highly protective antibody responses.

A December 2021 Nature story explains that the F protein changes its configuration once it fuses with cells into a post-fusion form. But targeting the pre-fusion, and less stable, form — as opposed to the post-fusion form — produced higher antibody responses, the researchers said in their 2013 study.

All of the vaccine candidates moving through the FDA approval process now target the pre-fusion F protein.

Dr. Alejandra Gurtman, Pfizer’s vice president of vaccine research and development, said during the VRBPAC meeting that the “ground-breaking structural work by the National Institute of Health elucidated that RSV F on the virus exists as an unstable pre-fusion form” — and only the pre-fusion form can bind to and enter a human cell. “Antibodies specific to the pre-fusion form are most effective at blocking virus infection,” she said, showing a graphic to illustrate how the pre-fusion F vaccine candidate produced about 50-fold higher RSV neutralizing antibodies in studies in primates than the historical candidates targeting the post-fusion F.

Some of the same scientists involved in the 2013 research on RSV similarly locked SARS-CoV-2’s spike protein into its pre-fusion form, laying the foundation for the development of the COVID-19 vaccines, as we’ve explained before.

What are the potential vaccines for older adults?

Pfizer and GSK have submitted applications to the FDA for their RSV vaccine candidates for adults ages 60 and older. These were the two vaccines discussed in the Feb. 28 and March 1 meetings of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Both vaccines are protein subunit vaccines — meaning they’re made from just a piece of the virus, in this case the stabilized RSV pre-fusion F protein. The pre-fusion F prompts an immune response but can’t cause RSV disease. The hepatitis B and pertussis vaccines are made in the same way.

Pfizer’s vaccine, called Abrysvo, employs pre-fusion F protein from RSV-A and RSV-B, subgroups of the virus. GSK’s vaccine, called Arexvy, combines the pre-fusion F from RSV-A with an adjuvant, a substance that can enhance the body’s immune response to the F protein. The adjuvant in the RSV vaccine candidate is the same, but a lower amount, as the one used in Shingrix, the shingles vaccine also produced by GSK.

Pfizer initially tested adding an adjuvant, but found “no substantial benefit” in immune response by including it, Gurtman said.

Moderna is also working on an RSV vaccine candidate for older adults, using mRNA technology, the same technology used in Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines, to deliver instructions to cells to make the stabilized pre-fusion F protein to trigger an immune response. Moderna has said it will submit an application to the FDA in the first half of this year.

Janssen, a Johnson & Johnson company, is working on an RSV vaccine for older adults that also targets the pre-fusion F protein, using both bits of the protein and a harmless adenovirus to deliver instructions to cells to make their own protein. The latter is the same type of technology used in the J&J COVID-19 vaccine. A spokesperson for the company told us it was analyzing phase 3 trial data.

Where are they in the FDA approval process?

The independent VRBPAC experts voted that the clinical trial data supported the safety and effectiveness of the Pfizer and GSK vaccines to prevent lower respiratory tract disease caused by RSV in the 60 and older population. The votes on the Pfizer vaccine were 7-4 for both effectiveness and safety; the GSK vaccine garnered a unanimous 12-0 vote on effectiveness and 10-2 on safety.

The FDA doesn’t have to adhere to that vote in making its decision on whether to approve the vaccines. Both pharmaceutical companies say they expect a decision from the FDA in May; GSK specifically says a decision would come by May 3. If approved, the vaccines would be available for the next RSV season, starting in the fall.

Both of the applications, accepted by the FDA in November and December, are under “priority review,” which means the FDA aims to make a decision in six months, instead of the standard 10 months. The agency grants priority review for drugs that “if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” the FDA says. This doesn’t change the length of clinical trials or “the scientific/medical standard for approval or the quality of evidence necessary.”

Again, Moderna and Janssen haven’t yet submitted to the FDA for approval.

How effective are they?

We have the most information about the Pfizer and GSK vaccines that were discussed by VRBPAC, so we’ll concentrate on those. Both companies reported high efficacy in preventing lower respiratory tract illness symptoms due to RSV.

Efficacy is the relative reduction in a clinical trial in illness between the vaccinated and placebo groups. It represents a lower risk of getting sick if vaccinated.

Both companies presented trial data for one RSV season. This was the primary objective for the trials, but participants are being followed for two RSV seasons in the Pfizer study and three seasons in GSK’s. The trials are ongoing. That means the data for both companies do not yet cover the current RSV season, which saw a surge in cases and hospitalizations for older adults as well.

GSK told us it expects to have data on the second RSV season in the Northern Hemisphere in the third quarter of this year.

Pfizer. Results from the main Pfizer phase 3 clinical trial in adults age 60 and older, which began in 2021 and is ongoing, showed a vaccine efficacy of 85.7% in preventing at least three lower respiratory tract illness symptoms due to RSV, with two cases in the vaccine group and 14 in the placebo group through one RSV season, or at least six months. Efficacy in preventing at least two symptoms was 66.7%, with 11 cases in the vaccine group and 33 in the placebo. Pfizer hasn’t yet published these results in a peer-reviewed journal.

Lower respiratory tract illness symptoms included cough, sputum production, wheezing, shortness of breath and tachypnea, or rapid breathing.

The trial didn’t include enough severe illness cases — defined as lower respiratory tract illness symptoms requiring hospitalization, the administration of oxygen or mechanical ventilation — to provide an analysis on vaccine efficacy for severe disease. There were only two hospitalizations due to RSV in the trial, both in the placebo group.

The trial enrolled 34,284 people in the U.S., Canada, Finland, The Netherlands, South Africa, Argentina and Japan, with about half getting the vaccine and half getting a placebo. Participants were 60 to 97 years old, and 37.4% were 70 or older.

Pfizer said the participants were healthy or with “stable chronic conditions,” and the data show about half in both the vaccine and placebo groups had at least one high-risk condition, such as heart or lung disease, diabetes, or were smokers.

GSK. GSK’s phase 3 trial efficacy data — which has been published in the New England Journal of Medicine — showed a vaccine efficacy of 82.6% in preventing RSV-confirmed lower respiratory tract disease in adults age 60 and older, with seven cases in the vaccine group and 40 in the placebo group. The efficacy against severe disease was 94.1%, with one case in the vaccine group and 17 in the placebo.

The definition of lower respiratory tract disease was similar to Pfizer’s but slightly different. Lower respiratory tract disease was two or more symptoms or “signs,” the latter of which included wheezing, crackles, rapid breathing, low blood oxygen levels and supplemental oxygen. Severe disease was defined as at least two “signs” or an assessment by the trial investigator, or the patient needing mechanical ventilation. (See slide 27.)

The trial, which began in 2021, enrolled nearly 25,000 people in 17 countries, with half of them getting the vaccine and the rest getting a placebo. About 40% of participants were considered frail or “pre-frail,” based on a gait speed test, about 95% had at least one comorbidity and about 40% had a “comorbidity of interest” associated with severe RSV.

The efficacy in preventing RSV-confirmed lower respiratory tract disease in that population of interest was 94.6%, with one case in the vaccine group and 18 in the placebo, but there were too few cases in the frail population to determine efficacy in that group.

VRBPAC’s vote: Pfizer. The FDA advisory committee voted 7 to 4, with one abstention, in favor of the available data adequately supporting the effectiveness of Pfizer’s vaccine candidate in preventing RSV-caused lower respiratory tract disease for adults 60 and older. The experts who voted yes said that the primary outcome in the trial was met, though some noted that the trial didn’t provide evidence on the prevention of serious outcomes.

Those who voted no said they’d like to see the additional data yet to come for another RSV season, since  the efficacy, thus far, was based on a relatively small number of cases — 44 total — with wide confidence intervals. As Dr. Jay M. Portnoy, a pediatrician at Kansas City’s Children’s Mercy Hospital who voted no, said, “One or two cases in the opposite direction could’ve change the results.”

A confidence interval is a statistical measure — in this case, a range of what the efficacy would be expected to be for the whole population.

There was also concern that the trial didn’t adequately study a high-risk population. Dr. Henry Bernstein, a professor of pediatrics at Hofstra University, said the vaccine should be created for the needs of “vulnerable populations, not healthy people.”

He said the efficacy against lower respiratory tract disease is “impressive,” but the vaccine “really didn’t do anything for hospitalization or death, which is one of the major things I suspect that we would want from a vaccine in protecting against or preventing respiratory disease.”

Some of those who voted no said they probably would be yes votes with the additional data to come.

VRBPAC’s vote: GSK. The advisory committee was unanimous — 12 to 0 — in saying the data supported the effectiveness of the GSK vaccine.

Several committee members noted that the data in the GSK trial were “a bit more representative of the population that’s really at risk of this disease” than the Pfizer trial, as Holly Janes, a biostatistics expert with the Fred Hutchinson Cancer Research Center, put it.

Portnoy said that while the efficacy data were similar to Pfizer’s, the confidence intervals were “narrower.”

Dr. Marie Griffin, a professor emerita at Vanderbilt University Medical Center, noted the unanimous vote would be seen as supporting the licensure of the vaccine, “and I don’t think necessarily everyone who voted yes thinks that the vaccine should be licensed at this point.” She said it was a “great study,” but “I would be more comfortable with … more years of data.”

Others echoed those comments. Dr. Stanley Perlman, a professor of microbiology, immunology and pediatrics at the University of Iowa, said he hopes the vaccine isn’t licensed for a year or two so that there are more data and “more comfort” with both safety and efficacy.

Dr. Amanda Cohn, with the National Center on Birth Defects and Developmental Disabilities, added that in order to see the impact of the vaccine, a high percentage of older adults would need to get it. “It may be that having more robust data … that we will be getting soon may in the long run actually be better for public health than getting this vaccine out” in the upcoming RSV season.

Moderna and Janssen. We have more limited information on these candidates, since the companies haven’t submitted to the FDA for approval and VRBPAC hasn’t discussed them.

Moderna reported in January that in a phase 3 trial, its vaccine showed an efficacy of 83.7% against RSV-related lower respiratory tract disease, defined as at least two symptoms and that there were “no clinically significant safety signals identified.” For Janssen, positive results from a phase 2b trial on efficacy and safety in the over-65 population were published in the New England Journal of Medicine in February.

What do the safety data show?

Pfizer. The company said the data show its vaccine was “safe and well tolerated.” Reports of pain at the injection site were low — 10.6% among vaccine recipients — and other reactions including fatigue, headache, and muscle or joint pain were reported in low and similar percentages in the vaccine and placebo groups.

However, there were three serious adverse events that the FDA and the study investigator deemed to be “possibly related” to the vaccine: an allergic reaction or “hypersensitivity” within eight hours of vaccination; a case of Guillain-Barré syndrome, a rare neurological disorder in which the immune system damages the nervous system; and a case of Miller Fisher syndrome, a variant of Guillain-Barré. The latter two conditions occurred in 66-year-olds, a man and a woman, about a week after vaccination.

While those are only two cases, given the number of trial participants, that translates to a Guillain-Barré case rate of about 1 in 9,000 people, much higher than the expected background rate of 1.5 to 3 cases per 100,000 people older than age 60 in the U.S. each year, the FDA said in its briefing document on the vaccine.

Guillain-Barré, often linked to a viral or bacterial infection, has been associated, rarely, with other vaccines, the CDC says. While the syndrome can lead to lasting nerve damage, most people recover.

There were no deaths in the trial deemed to be related to the vaccine, and the number of deaths in the vaccine group, 52, was similar to that in the placebo group, 49. Within one month of vaccination, there was an imbalance in atrial fibrillation events, or irregular heartbeat – 10 in the vaccine group and four in the placebo. The trial investigators didn’t consider any of those to be related to the vaccine. The FDA is reviewing those cases.

In an earlier, small trial in which some participants received the RSV vaccine and an influenza vaccine at the same time, Pfizer saw a trend in “decreased [immune] responses to the flu vaccine,” Gurtman said. The company is studying this in a larger trial.

GSK. The company said the data show the vaccine was “well tolerated” and had an “acceptable safety profile.” Pain at the injection site was the most common side effect reported; nearly 61% of a subset of participants who were solicited for such feedback reported injection-site pain. Fatigue, muscle aches, headache and joint stiffness were also reported at rates higher than the placebo group.

Fatalities were balanced between the vaccine and placebo groups.

There was one case of Guillain-Barré syndrome nine days after vaccination that was considered “to be related to vaccination” by the FDA and the study investigator, the FDA briefing document on the vaccine said. That would be a rate of 1 per 15,000 people. And there were two cases of acute disseminated encephalomyelitis, or ADEM, a neurological disorder involving swelling in the brain and spinal cord, both in 71-year-olds in a smaller phase 3 trial, with 890 participants, studying co-administration with the flu vaccine.

In one of those cases, a man experienced symptoms seven days after vaccination and later died. The other case was a woman who experienced symptoms 22 days after vaccination and recovered. The study investigator said the cases were “possibly related” to the flu vaccine, and the FDA considered them to be “possibly related” to either the flu or the GSK vaccine.

There was also an imbalance in atrial fibrillation within 30 days of vaccination, with 10 cases in the vaccine group and four in the placebo. Dr. Peggy Webster, vice president and head of vaccine safety at GSK, said during the VRBPAC meeting that six of the cases in the vaccine group and two in placebo were in people with a history of the condition. As with the Pfizer vaccine, the FDA is reviewing those cases.

The FDA and the study investigator considered six other cases of potential immune-mediated diseases to be possibly related to the vaccine: gout, pancytopenia, Bell’s palsy, psoriasis and Graves’ disease. There was also a case of gout in the co-administration study, possibly related to the flu or GSK’s RSV vaccine, FDA said.

In the co-administration study, there is “no evidence for interference in immune responses” to the flu and GSK vaccine, FDA said.

VRBPAC’s vote: Pfizer. The VRBPAC vote on the Pfizer vaccine was 7-4, with one abstention, that the data supported the safety of the vaccine — but with only one committee member, Hofstra University’s Bernstein, voting no on both efficacy and safety.

Those who voted yes said the available data show the vaccine is safe, and more information on Guillain-Barré wouldn’t come through the clinical trial, but rather though post-approval surveillance, which would involve a lot more people getting the vaccine. The FDA has requested that Pfizer develop such a follow-up study. Some said that a potential co-administration issue with the flu vaccine was an implementation issue, not a safety issue for this vaccine.

The four no votes were concerned about Guillain-Barré and not having more data on co-administration with the flu vaccine.

Griffin, of Vanderbilt University Medical Center, talked about safety in terms of benefit versus risk. She said she would be less concerned about the safety signal in a population that had a very high hospitalization risk, but that population was underrepresented in the trial. Given the Guillain-Barré concern, she said, the “benefit for relatively healthy older people … is not that great, compared to a possible high risk of a very severe outcome.”

Dr. Daniel Feikin, a respiratory disease consultant and a yes vote, said a Guillain-Barré safety signal is “potentially there.” But there were “only two cases,” which had “a potential other explanation for GBS.” Like other committee members, he said he didn’t think more data on this would be available except through a post-marketing, meaning after approval, follow-up study. While the phase 3 trial is following participants for two RSV seasons, the vaccination is only given before the first season.

Some of the experts expressed concern about potential vaccine hesitancy among the public, given the experience with the COVID-19 vaccines, particularly vaccination rates with the booster shots. Portnoy, who voted yes on the safety question, said before the vote: “I think we have to be really careful before we send the vaccine out to cover large groups of patients given the hesitancy that occurred surrounding COVID vaccine, which turned out to be a very safe vaccine.”

VRBPAC’s vote: GSK. The committee voted 10-2 that the data supported the safety of the vaccine.

Dr. Hana El Sahly, chair of the committee and a professor of molecular virology and microbiology at Baylor College of Medicine, and Griffin voted no due to concern over the ADEM and Guillain-Barré case rates. El Sahly said the inflammatory neurologic diagnoses “do rise above the average seen,” and while she agrees that post-marketing surveillance can help answer whether this is a true safety signal, “once a vaccine is licensed it is really hard to collect data given our decentralized health care delivery system. … Pre-licensure is probably where most of the effort should go when feasible.”

Griffin said the ADEM and GBS cases, versus two hospitalizations in the placebo group, made it “hard to weigh the risks and benefits,” and she also wanted to see more data on co-administering the vaccine with the flu vaccine and the COVID-19 vaccine, since that’s likely the way vaccination would be done in the public.

Perlman, who abstained on this question for Pfizer, said he was “a little more convinced” on the safety of the GSK vaccine, noting there was only one case of Guillain-Barré and that both ADEM cases occurred in South Africa among about 150 participants, raising questions about whether those were due to vaccination.

Bernstein, who had voted no on both questions for the Pfizer vaccine, also said “it’s just not clear whether or not there’s a true safety signal” with ADEM or atrial fibrillation and that post-marketing surveillance would be helpful in that regard. He added that he doesn’t think the vaccine needs to be rushed to market, “if in fact it’s at the expense” of the older population getting flu and COVID-19 shots.

Who would get them and how often?

It’s too soon to say. The Pfizer and GSK clinical trials don’t yet have data through a second RSV season to answer the question of how long vaccination would provide protection — though the VRBPAC members talked about it potentially being an annual vaccine, like the flu shot.

After the FDA approves vaccines for use, the CDC, drawing upon recommendations from its Advisory Committee on Immunization Practices, issues guidelines on who should get the vaccines and how frequently. However, RSV “work groups,” which include ACIP members, presented the available data on the Pfizer and GSK vaccines and information on RSV in a late February ACIP meeting. The work groups make recommendations to the entire ACIP, but then the work groups do not vote on the final guidance.

The majority opinion of the adult RSV work group was that both vaccines should be recommended for those 65 and older, but not those 60 to 64. Also, there was “a substantial minority opinion” not to recommend the vaccines based on the available data, the CDC’s Dr. Michael Melgar, the lead of the adult RSV work group, said, due to concern about risk-benefit balance and “underrepresentation” in the trials of adults older than 80 who are most at risk of severe illness from RSV.

A CDC spokesperson, Katherina Grusich, told us in an email that “[n]o votes were taken,” at the February ACIP meeting, “but the discussion – which included robust deliberation around available safety, cost and effectiveness data, and potential clinical considerations – will help inform future ACIP policy recommendations” if the vaccines are approved by the FDA.

Update, March 30: Janssen announced on March 29 that it would end its RSV adult vaccine program, a strategic decision to prioritize its investments.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Q&A on RSV Vaccine Candidates for Older Adults appeared first on FactCheck.org.

In 2020, the National Institute of Allergy and Infectious Diseases awarded 11 grants to scientists so they could investigate how and where infectious agents emerge from wildlife and cause illness in humans.

Although the grants were reviewed and scored by groups of independent scientists prior to public disclosure of any outbreak, Republican Rep. Jim Jordan baselessly suggested that former NIAID Director Dr. Anthony Fauci gave scientists one of the grants — worth $9 million — to alter the scientific narrative on how the COVID-19 pandemic started. Key to this shift in opinion, Jordan said, was a Feb. 1, 2020, call involving Fauci and the scientists.

At a House Select Subcommittee on the Coronavirus Pandemic hearing on March 8, Jordan claimed Fauci pressured virologists Kristian Andersen of Scripps Research and Robert Garry of Tulane University to change their minds and support the theory that the virus transferred naturally from animals to humans, rather than originating in a lab. This claim of a quid pro quo has spread widely on social media.

Not only is there no evidence for this, but the timing of the grant is inconsistent with such a claim. Moreover, NIAID directors do not unilaterally decide who gets funding; groups of outside scientists review proposals and provide scores that are the primary determinants of funding.

Andersen and Garry did appear to undergo a shift in early 2020 in their thinking on SARS-CoV-2, the virus that causes COVID-19. They moved from finding the SARS-CoV-2 genome “inconsistent with expectations from evolutionary theory,” as Andersen put it in an email, to helping author a Nature Medicine paper stating that it was not “a laboratory construct or a purposefully manipulated virus.”

Fauci said in a Fox News interview on March 9 he has “always kept an open mind” on the origins of COVID-19. Andersen, meanwhile, has explained that his thinking shifted due to factors like speaking with his colleagues and learning more about coronaviruses, not due to any outside pressure to stick to a particular narrative.

The origins of COVID-19 have not been conclusively determined, although most scientists think the virus spilled over from animals into humans. Epidemiological and genomic evidence points to the virus spilling over at least twice at the Huanan Seafood Wholesale Market in Wuhan, China, which was known to be illegally selling raccoon dogs and other species susceptible to the virus. 

On March 16, news reports announced that coronavirus-positive samples collected from the market contained genetic material from raccoon dogs and other animals, further supporting — but not proving — this hypothesis.

Much of the hearing was devoted to rehashing lab leak arguments that many scientists have already said don’t hold water, including the notion that specific features of SARS-CoV-2 suggest the virus was manipulated in a lab and that the virus was already pre-adapted for human transmission. 

Scientists who have looked into these questions say nothing about the viral sequence indicates lab tinkering, as we’ve written. Being a pandemic virus, SARS-CoV-2 is by definition special, but it’s in no way uniquely human. It infects a wide array of animals and is a generalist virus — and has in fact evolved over time to become better at human-to-human transmission, as the alphabet soup of variants attests.

The idea that the $9 million grant was a reward dates back at least as far as 2021. In May of that year, Rutgers University biologist Richard Ebright tweeted without evidence that there was a “CREID pro quo,” a pun on quid pro quo, involved in the funding of grants for Centers for Research in Emerging Infectious Diseases, or CREID.

Fauci, Andersen and Garry all categorically dismiss the claim that the grant was a reward for adhering to a particular narrative about the pandemic. They have also explained that key decisions that led to funding the grant were made prior to February 2020.

“The grant was reviewed by a peer review and put before an independent council and approved before the meeting even took place,” Fauci said during the Fox News interview, referring to the Feb. 1 phone meeting. “So, to assume that they were getting a $9 million grant because of the fact that we tried to get them to change their mind is beyond ludicrous.”

The same day of Fauci’s interview, Andersen also denied the allegations, tweeting: “👇 is exactly right. The idea that there was a ‘preferred narrative’ is false. Read the emails. And papers. In full. The idea that there was a ‘bribe’ to change a narrative is beyond ludicrous. The idea that this was _anything_ other than scientific inquiry is absurd. End of.”

And Garry told us in a March 13 email: “The claims that people like Richard Ebright are making are absurd on their face. They know that this is not how NIH grant reviews work.”

Researchers Say Changes in Thinking Reflect Scientific Process

Three out of four people who testified at the House hearing are proponents of the theory that COVID-19 came from a lab, and none are scientists who have published work investigating the origins of the coronavirus. One of these lab leak proponents was Dr. Robert Redfield, former director of the Centers for Disease Control and Prevention.

Redfield said he was excluded from a Feb. 1, 2020, call with Fauci, Andersen, Garry and others due to his views on the origins of COVID-19. (Fauci has argued that this claim does not add up, as we will explain below.)

Redfield, an infectious disease doctor with a long history of researching HIV, repeatedly invoked his credentials as a virologist. But several of his statements, including that SARS never spread between humans and that SARS-CoV-2 infections began in September 2019, are incorrect or unsupported, scientists pointed out.

Redfield said he told Fauci that his hypothesis was that SARS-CoV-2 “most likely” had a lab origin and that “we need to aggressively investigate both hypotheses.” Redfield also said that he was excluded from the meeting “because I had a different point of view and I was told they made a decision that they would make this confidential until they came up with a single narrative, which I will argue is antithetical to science.”

Jordan and others have argued that this Feb. 1 call was pivotal, causing Andersen, Garry and others to change their minds on COVID-19 origins. 

Andersen and Garry’s thoughts on the pandemic do appear to have changed over time. In an email to Fauci sent Jan. 31, 2020, Andersen expressed concern that “some of the features (potentially) look engineered,” referring to the SARS-CoV-2 genome.

Andersen went on, “I should mention that after discussions earlier today, Eddie, Bob, Mike, and myself all find the genome inconsistent with expectations from evolutionary theory. But we have to look at this much more closely and there are still further analyses to be done, so those opinions could still change.” 

Emails then indicate that Andersen, Fauci, Garry, then-NIH director Dr. Francis Collins, Edward (Eddie) Holmes and Michael (Mike) Ferguson, along with other researchers, were invited to the Feb. 1 call. 

After further analysis, Garry, Andersen, Holmes and other scientists drafted a paper that was published in Nature Medicine on March 17, 2020. 

“Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus,” they concluded. Notably, the paper did not entirely dismiss the idea that the virus could have resulted from selection during passage in cells or animals in a laboratory, although the writers explained that they did not find this hypothesis to be plausible.

According to a memo from the Republican staff of the Select Subcommittee on the Coronavirus Pandemic to the panel’s members, Andersen originally wrote to the journal Nature that Fauci, Collins and scientist Jeremy Farrar “prompted” the authors of the paper to “[work] through much of the (primarily) genetic data to provide agnostic and scientifically informed hypothesis around the origins of the virus.”

Republican staffers also claimed in the memo that the Nature Medicine paper was authored Feb. 4, 2020, citing an email that Holmes wrote on that day. But the email showed that Holmes simply shared “our summary so far” on that date and promised to “finish as soon as we can.”

Jordan said during the hearing: “Three days after they say it came from a lab, they change their position and the only intervening event is a conference call with Dr. Fauci and Dr. Collins, again, a call that Mr. Redfield was not allowed to be on, the head of CDC and on the coronavirus task force. And then three months later, shazam, they get 9 million bucks from Dr. Fauci. Well, isn’t that something.” 

In his recent Fox News interview, Fauci responded to Jordan’s allegation, noting that at the time, he did not have strong opinions about how the coronavirus originated.

“First of all, I wasn’t leaning totally strongly one way or the other. I have always kept an open mind. As the data evolved and evolutionary virologists began to look at the data, it looked much more likely that it was a natural occurrence from an animal reservoir,” he said. “I have always kept a completely open mind that it could be one or the other.”

Andersen told us in a March 13 email: “As I (and others) have stated repeatedly, there was no ‘preferred narrative,’ nor was there a push to only consider a natural origin — Dr. Fauci (or Dr. Collins) simply suggested we consider writing a paper on whatever we found, but otherwise had no role in the drafting, editing, approval, or publication of our paper. The data clearly points to a market origin of the pandemic – that has been clear since February 2020 and additional data have only supported that conclusion further. Although a formal proof is still lacking, and likely will always be lacking, as is the case for virtually all other outbreaks, epidemics, and pandemics.”

Andersen decided engineering was unlikely as he learned more about coronaviruses, he explained in a New York Times interview published in June 2021. At the time of his Jan. 31 email, he said, he was not aware of other viruses with the same features as SARS-CoV-2.

Speaking in a podcast episode released on March 11, Andersen explained: “It’s really important that we distinguish between what did we know at the time of asking those questions versus what did we know just a few days later after tons of conversations with our colleagues versus new evidence coming in, more analyses being done, all these different things, plus what do we know now today?” Multiple new sources of insight, both publicly documented and not, helped shape his views on the origins of COVID-19, he said.

In response to the idea that Redfield was excluded from the call due to his views, Fauci pointed out on Fox News that “half the people on the call were of the opinion that it might be a lab leak. So, his rationale of why he thought he was excluded is an invalid rationale.”

Fauci also said that he had “nothing to do with who would be on that call,” adding that the call was organized by evolutionary virologists including Andersen and Holmes.

Holmes shared a BBC article on the hearing and tweeted on March 8, “All I can say is that I just don’t remember Redfield’s name coming up when Jeremy Farrar and I were discussing who to have on the very rapidly convened teleconference. I very likely didn’t [know] who the head of the US CDC was (given that I live in Sydney).”

Key Grant Review Step Happened in 2019

Former New York Times journalist Nicholas Wade, who wrote an influential blog post in 2021 about the possibility of a lab leak, also testified at the House hearing. He referenced the claim that the grant was some form of quid pro quo in his written testimony.

Wade’s written testimony prompted Jordan to ask him why he thought the scientists changed their position.

After initially saying, “I don’t know what the reason was,” Wade said, “If you’re looking at the timeline, on May 21, just a few weeks after the Nature Medicine article had come out, two of the signatories of the original email to Dr. Fauci — that’s Dr. Andersen and Dr. Garry — were awarded a $9 million grant.”

“So there’s 9 million reasons why they changed their mind,” Jordan interrupted.

But as we said before, Fauci noted on Fox News that key steps in scoring the grant and approving it for funding took place prior to the Feb. 1 meeting.

Andersen, Garry and colleagues submitted an application to establish the West African Research Network for Infectious Diseases, a coalition of scientists in Africa and the U.S. who are researching infectious agents and creating new testing technology to “mitigate the effects of future pandemic threats.” The deadline for submitting the application was June 28, 2019.

To decide whether to fund grants, the NIAID recruits panels of scientists to review their peers’ applications and give them scores, which are translated into an overall impact score between 10 and 90, with 10 being the best. The meeting to review applications for the grant took place in November 2019. 

Garry told us that the grant application received an impact score of 27 — meaning the reviewers considered the project to be of “high” impact, according to NIAID scoring criteria. “Your overall impact score is the key review outcome, the main basis for a funding decision by an NIH Institute,” the NIAID website reads.

The next step is review before an advisory council, a group of experts and lay members that “looks at applications with potential barriers to funding such as human subjects and animal concerns, or special circumstances such as foreign applications and renewal applications requesting more money than the limit,” according to the NIAID website. NIAID calls this second-level review a “small step” after the hurdle of initial peer review. The advisory council for the grant met in January 2020.

The advisory council made a funding recommendation for the grant prior to the Feb. 1 call, Garry told us, which was also confirmed by Fauci in his Fox News interview.

Once a grant has been recommended for funding, the NIAID website explains, NIAID “makes the final decision” on whether a grant will be awarded, with potential obstacles to funding including having a score below a certain level or not meeting administrative requirements. Administrative requirements can include things like providing additional information on budget, human subjects, and animal subjects, according to the website.

These administrative steps take time, Andersen and Garry explained, and this is why the award notice date for their grant is May 21, 2020.

Andersen pointed out in the March 11 podcast that the Feb. 1 call included scientists from around the world with diverse sources of funding. “The basic idea here of the cover-up just doesn’t make sense from that,” he said.

Holmes, a co-author on the Nature Medicine paper, said in the podcast: “What you saw was scientists scrambling to understand these data.” Fauci “didn’t tell us what to think. He didn’t tell us to write the paper. He didn’t write the paper. We did it. And we just wanted to understand the science. We thought it was important to get the message out there quickly and coherently.”

Holmes explained in a March 9 tweet that he applied for a CREID grant at the same time and did not receive funding. As we’ve said, Holmes was mentioned in Andersen’s Jan. 31 email as suspecting SARS-CoV-2 to be engineered and was invited to the Feb. 1 meeting, just like Andersen and Garry. 

“Fundable scores will be fundable scores,” Holmes said on Twitter, referring to the fact that sufficiently good impact scores get funding.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post No Evidence Scientists Received Grant for Changing Opinion on Pandemic Origins, Contrary to Claims appeared first on FactCheck.org.

SciCheck Digest

People online are touting the results of a Cochrane review to incorrectly claim that it shows masks “don’t work” against the coronavirus. But the primary conclusion of the review is that it’s uncertain from randomized controlled trials whether mask interventions in the community help slow the spread of respiratory illnesses.

What evidence supports the use of face masks against the coronavirus?

Full Story

Three years into the COVID-19 pandemic, few topics have become as polarizing as masks. Some people claim masks are a panacea; others say masks are worthless or worse. The evidence, however, is more complicated and nuanced — and points somewhere in between, experts told us.

Reigniting the debate — and sparking misinformation about masks from both sides — is a recently released update from Cochrane, a highly-respected British nonprofit that specializes in systematic reviews of health care interventions.

The Jan. 30 review found that based on existing randomized controlled trials — which tested the effectiveness of interventions encouraging people to wear masks, rather than testing the effectiveness of masks themselves — wearing masks in the community “probably makes little or no difference” to the number of people with influenza or COVID-19-like illnesses.

“The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks,” the review reads.

The authors, however, also emphasized the “uncertainty about the effects of face masks.” And only two trials in the review assessed the effectiveness of a mask intervention for COVID-19.

“The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions,” the authors wrote. “The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect.”

In other words, there isn’t good evidence from randomized controlled trials that encouraging mask use in the community prevents the spread of respiratory diseases, but the issue also hasn’t been studied very well. So the real answer is unknown.

Despite the limitations, many people misinterpreted the review to be saying that masks “don’t work.”

“12 RESEARCH STUDIES PROVE MASKS DIDN’T WORK,” reads an Instagram post about the Cochrane review from the Liberty Counsel, a Christian religious liberty organization.

“Scientific review confirms doubters’ stance on masks and COVID-19,” declared a popular Instagram post from Fox News.

The lead author of the Cochrane review, Tom Jefferson, seemed to endorse this interpretation when he said in an interview, later quoted by conservative columnist Bret Stephens in a widely viewed opinion piece for the New York Times, “There is just no evidence that they” — referring to masks — “make any difference.”

But experts — and the Cochrane Library — say this is an inaccurate representation of what the review found.

“Many commentators have claimed that a recently-updated Cochrane Review shows that ‘masks don’t work’, which is an inaccurate and misleading interpretation,” Dr. Karla Soares-Weiser, the editor-in-chief of the Cochrane Library, said in a March 10 statement.

“It would be accurate to say that the review examined whether interventions to promote mask wearing help to slow the spread of respiratory viruses, and that the results were inconclusive,” she continued. “Given the limitations in the primary evidence, the review is not able to address the question of whether mask-wearing itself reduces people’s risk of contracting or spreading respiratory viruses.”

Soares-Weiser went on to note some limitations mentioned in the abstract of the review, including the issue of whether people in the trials actually wore masks. She said the group would be working with the authors to reword the “Plain Language Summary,” which she said “was open to misinterpretation.”

In an interview with the New York Times, Soares-Weiser was also critical of Jefferson’s comments, which she said were not accurate. 

Jefferson, who is a senior associate tutor of continuing education at Oxford University, has been the lead author of the Cochrane review on physical interventions to reduce the spread of respiratory viruses since its inception in 2006.

He has endorsed several unorthodox views about COVID-19 and some of his writing has been republished by the Brownstone Institute, a group that has described itself as the “spiritual child” of the widely criticized Great Barrington Declaration. In the latest update to the Cochrane review, under a section in which authors disclosed potential conflicts of interest, he reported “declaring an opinion on the topic of the review in articles for popular media.”

Cochrane Review

One reason the Cochrane review has garnered so much attention is because Cochrane has a reputation for excellence. 

The group doesn’t do original research, but performs what are called systematic reviews, which summarize the collective literature on a particular question in a careful and predetermined way that minimizes bias. This prevents someone from cherry-picking studies that could sway the findings, for example. 

The results from different studies are often then combined statistically in what is called a meta-analysis, which uses a weighted average to summarize the effectiveness of a given intervention.

Cochrane is particularly known for its robust and transparent methods and is therefore often considered to be the gold standard for such reviews.

In this case, the review focused not just on mask interventions, but on physical interventions more broadly, including hand hygiene programs, for the prevention of respiratory illnesses, primarily influenza. 

Similar to a 2020 update on this topic, but in contrast to earlier editions, the systematic review did not consider observational studies about masks, and instead was limited to randomized controlled trials and cluster randomized controlled trials.

Randomized controlled trials are considered one of the best kinds of evidence, since they randomly assign people to an intervention or control group, or in the case of a cluster design, randomly assign groups of people to different interventions. This allows for a fairer comparison of what the intervention actually does, although every study has some limitations.

The 2023 update added 11 new randomized controlled trials, for a total of 78 trials. But only about a dozen of these evaluated the effect of a mask intervention, such as providing people with a mask and encouraging them to wear it, compared with no such intervention, on the number of respiratory illnesses. And only two were conducted during the pandemic for the coronavirus. Five other trials, none of which were done for the coronavirus, compared N95 or other similar respirators with surgical masks, mostly in health care workers.

Despite some claims to the contrary, including a now-deleted Twitter thread that incorrectly alleged the Cochrane authors made errors in their meta-analysis, multiple experts told us the review did not have any notable flaws.

“It is a well done review. It’s been done tightly by the best standards by competent people,” Julii Brainard, a senior research associate at Norwich Medical School at the University of East Anglia in the U.K., told us. “It may seem very critical of primary evidence, but Cochrane reviews are always very critical.”

“The review itself is pretty standard for Cochrane,” Gideon Meyerowitz-Katz, an epidemiologist from the University of Wollongong in Australia, said in an email, adding that “it is of a similar quality to most Cochrane reviews — I cannot find any major errors in the process.”

But some experts objected to some of the language the authors used to summarize their results and took issue with certain decisions and interpretations of the review. All agreed that it was incorrect to conclude that the review shows masks “don’t work.”

Review Criticisms

Benjamin Cowling, an epidemiologist at the University of Hong Kong who has studied masks, said he thought the review was very similar to other systematic reviews on the topic. But he found the authors’ conclusion that wearing masks in the community “probably makes little or no difference” to be problematic.

He noted that the confidence intervals for the meta-analysis for unconfirmed and lab-confirmed influenza and COVID-19 “go down as low as 0.84 and 0.72,” and said that “these effects (16% reduction and 28% reduction, respectively) would not be considered little or no difference.” 

Cowling has long said that community masking could reduce transmission by around 10% to 20% — “a small to moderate effect which is worthwhile,” he said, and views the Cochrane review as “completely consistent with that.”

Meyerowitz-Katz also didn’t think the wording in the review was “entirely reasonable,” adding that one of the review authors told him the group had debated the phrasing.

“Specifically I think they should have downgraded the certainty from ‘may or probably’ to very low certainty language, because they are combining influenza with COVID-19,” he said. “This is, of course, a bit subjective both on my part and theirs, but it’s important.”

One criticism about the review is that it combined results from flu and COVID-19 studies. Only two of the 12 main studies on masks were conducted during the COVID-19 pandemic.

Meyerowitz-Katz said the “entire purpose of running this review” was to determine whether mask interventions were effective in preventing COVID-19 in communities, and it basically found there wasn’t much research examining that. “So why do the review at all?” he said.

“It was reasonable to look at evidence on other respiratory viruses at the beginning of the pandemic when we didn’t have evidence on SARS-CoV-2,” Dr. Roger Chou, a professor of medical informatics and clinical epidemiology at Oregon Health & Science University, said, referring to the virus that causes COVID-19. “But now that we have evidence on SARS-CoV-2, I don’t think that is the best approach.”

And looking at the COVID-19-specific studies, the findings are still uncertain, but lean toward a small protective effect, several experts said.

A cluster randomized controlled trial published in the journal Science in December 2021 found that handing out free masks and promoting their use in communities in rural Bangladesh led to a nearly 30 percentage point increase in mask wearing and reduced the risk of COVID-19-like illness by about 10%. 

A randomized controlled trial from Denmark, published in Annals of Internal Medicine in November 2020, identified an 18% reduction in risk of coronavirus infection among individuals who received free surgical masks and were told to wear them outside the home, but this result was not statistically significant. We’ve explained before that the trial was only designed to detect a large effect of 50% or more.

“Taken together, these two RCTs are consistent with a small reduction in risk,” Chou said. “The trials are not perfect, but it is very challenging to do these studies and I haven’t seen anything to invalidate the results of the studies.”

Chou, who is an expert in evidence-based medicine and has co-authored a rapid review about the effectiveness of mask interventions, also said that both trials might have underestimated the benefits of masks.

In the Bangladesh trial, for example, less than half of the people in the intervention arm wore masks, and with higher adherence the benefits might have been greater, he said. He added that the Danish trial wasn’t designed to see whether masks helped prevent those who were wearing masks from spreading COVID-19, or what is known as source control, so it may not have captured the true value of masks.

Meyerowitz-Katz noted that since the cutoff for consideration with the Cochrane review, a third randomized controlled trial on masks during the pandemic has been released as an unpublished preprint. Aggregating the three studies together, he said, “they show a consistent and fairly convincing effect.”

“To me, this shows that there is a reasonably clear modest benefit to community masking interventions during the COVID-19 pandemic, decreasing the rate of infections in groups of people who are given masks and told to wear them by ~13%,” he said. “That’s quite an important benefit in the context of a pandemic.”

Brainard, however, who is an expert on systematic reviews and published a review of the evidence on masks earlier in the pandemic, thought it was reasonable to group the influenza and COVID-19 studies together. She nevertheless agreed that the primary message of the review should be one of uncertainty.

“I can’t argue with the Authors’ own written conclusions: the evidence quality is variable and creates a huge amount of uncertainties,” she said in an email. “We can’t tell from available evidence that masks prevented infections according to our usual standards, which is 95% confidence that protection was achieved.”

That’s different from saying that masks don’t work for community spread or for an individual. And it’s also different, she said, from saying that mask mandates don’t work, since in trials mask-wearing is voluntary, rather than being required for everyone in the community.

“It is lamentable that during [the] pandemic not enough RCTs were done to [have] better evidence what NPIs work or not,” she said, referring to non-pharmaceutical interventions.

How to Think About Masking

One point of confusion for many people is that lab studies show masks, mostly well-fitting and high-filtering N95 respirators, are good at blocking viral particles. This is evidence that masks can in theory be quite effective, both for individuals and for larger populations.

Some scientists have pushed for people to use better masks, especially N95 respirators, if people truly want their masks to work.

But as we’ve explained before, this mechanistic evidence doesn’t necessarily mean that when public health officials recommend masks that this intervention will work to limit spread in the community.

“Showing that N95s stop particles in mannequins only proves that they can plausibly help, but if people hate wearing them, or don’t wear them properly, or only have access to cloth masks, etc, then the actual intervention will not be as effective,” Meyerowitz-Katz said.

Many observational studies have been done to try to understand what masks or mask interventions do, and Chou said they have “generally found masks to be associated with reduced risk of SARS-CoV-2.” But they have “major limitations,” he said, since it’s hard to know if masking is the reason for the differences between groups.

Still, Chou said that overall, this other evidence outside of randomized controlled trials “supports some benefits of masks.”

“I think the evidence indicates that masks likely have small benefits for individuals in preventing COVID-19 (~15% reduction), though with only two RCTs more evidence would of course be helpful for clarifying the benefits,” he said. 

“Even if the benefits are small for an individual, they are still important when considered from a population/public health perspective,” Chou added.

Brainard suspects that masks may not make as much of a difference as people may have hoped at the beginning of the pandemic.

Surgical masks “probably help prevent respiratory infections,” she said, but only a little — and by delaying infection rather than fully preventing it.

“Many people hate wearing masks, including people who believe that masks are truly very protective. Any intervention that must be sustained for long periods but people find difficult to sustain is not a great intervention,” she said.

But even if it turns out that mask recommendations don’t do very much, that doesn’t mean it was wrong to try them.

“Buying time until vaccines (or an amazing treatment) could be developed was the purpose of the masks,” she said. “My take is that public health officials in 2020-21 didn’t have a lot of options: without an effective vaccine, yet they couldn’t make people stay at home forever. Masks were a reasonable thing to try.”

Cowling agreed that the main function of masks is to delay infection, and that people should have realistic expectations for them.

“Ultimately even a very careful person will be infected eventually, but masks could delay that or reduce the rate of infection from once per year to once every few years, perhaps,” he said. “Community masking is not aimed to prevent everyone from ever getting infected, the aim is to reduce transmission and ‘flatten the curve’, reducing peak healthcare demand, or to work in combination with other measures like social distancing to contain transmission in the short-term.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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Gorski, David. “The ‘spiritual child of the Great Barrington Declaration’ promotes antivaccine misinformation.” Science Based Medicine. 24 Jan 2022.

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Brainard, Julii. Senior research associate, Norwich Medical School, University of East Anglia. Emails to FactCheck.org. 1 and 9 Mar 2023.

Meyerowitz-Katz, Gideon. Epidemiologist, University of Wollongong. Emails to FactCheck.org. 2 and 9 Mar 2023.

Cowling, Benjamin. Professor and Division Head, Division of Epidemiology and Biostatistics, University of Hong Kong. Email to FactCheck.org. 28 Feb 2023.

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Bundgaard, Henning et al. “Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers: A Randomized Controlled Trial.” Annals of Internal Medicine. 18 Nov 2020.

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Nanque, Line M. et al. “Effect of Distributing Locally Produced Cloth Facemasks on COVID-19-Like Illness and All-Cause Mortality – a Cluster-Randomised Controlled Trial in Urban Guinea-Bissau.” Lancet preprint. 5 Jan 2023.

McDonald, Jessica. “The Evolving Science of Face Masks and COVID-19.” FactCheck.org. 2 Mar 2021.

Brosseau, Lisa M. et al. “COMMENTARY: Wear a respirator, not a cloth or surgical mask, to protect against respiratory viruses.” CIDRAP. 23 Feb 2023.

McDonald, Jessica. “COVID-19 Face Mask Advice, Explained.” FactCheck.org. 6 Apr 2020.

The post What the Cochrane Review Says About Masks For COVID-19 — and What It Doesn’t appeared first on FactCheck.org.

SciCheck Digest

Russia developed a COVID-19 vaccine, Sputnik V, in 2020. President Vladimir Putin has said he received three doses of the vaccine, and the government continues to urge Russians to get vaccinated against the disease. But social media posts falsely claimed Putin “ordered the destruction of all” COVID-19 vaccine stockpiles in Russia.

Full Story

Russia was quick to develop its own COVID-19 vaccine — named Sputnik V — and begin administering first doses to Russians in late 2020.

Russia then used Sputnik V as a tool of diplomacy, signing agreements to distribute 700 million doses globally. The Kremlin and the Russian Direct Investment Fund charged with promoting the vaccines decided to pursue commercial deals for the vaccine with 69 countries to use Sputnik V instead of the larger COVAX distribution program created by the World Health Organization.

But Russia ran into numerous setbacks both domestically and globally. Russian citizens had a deep distrust of Sputnik V, prolonging the rollout of the vaccine, along with larger cultural anti-vaccine sentiment. Globally, Russia struggled to keep its promise of distributing 700 million vaccination doses, exporting only 108 million doses, as of June.

Russian President Vladimir Putin endorsed the Sputnik V vaccine. “I know it has proven efficient and forms a stable immunity,” he said in August 2020, 

Addressing the State Duma, Russia’s lower house of the Federal Assembly, in October 2021, Putin said, “You know that the number of infections is growing in many regions and medical specialists are working in difficult conditions. We all know well that the vaccination can save us from the virus and from a severe course of the disease. It is necessary to step up the vaccination pace.” 

Because of low vaccination rates, numerous Russia regions introduced mandatory vaccinations in 2021 for some public sector workers and people over 60 years old.

Putin said in November 2021 that he had received three Sputnik V doses, plus an experimental nasal spray, in hopes of increasing vaccination rates in the country. 

Currently, nearly 55% of the Russian population is fully vaccinated, with 61% receiving at least one dose.

Despite the efforts to encourage vaccination in Russia, a March 4 article in Real Raw News falsely claimed that Putin had “ordered the destruction of all Covid-19 vaccine stockpiles on Russian soil.” The article falsely claimed that the order was based on a “connection” between the vaccine and a “sudden surge” of HIV infections. 

Real Raw News has a disclaimer on its “about us” page stating, “This website contains humor, parody, and satire.” But there is no such disclaimer on the online article.

There is no evidence that any COVID-19 vaccine or the virus itself has caused HIV, as we’ve previously written. Russia does have a rising HIV infection rate, but that is part of a larger five-year trend unrelated to COVID-19 vaccinations. 

An Instagram post made similar claims, while also referring to the strangulation of a Russian scientist and co-creator of Sputnik V, Andrey Botikov. The Investigative Committee of the Russian Federation looking into Botikov’s death reportedly said it had a suspect in custody.

There is no evidence to suggest that Putin ordered the destruction of COVID-19 vaccine stockpiles. To the contrary, the Russian Ministry of Health said on Telegram on March 5 that it had replenished supplies of Sputnik V following shortages.

The health ministry’s post, which appeared a day after publication of the Real Raw News article, also touted Sputnik V as effective against severe COVID-19 and death, especially for those over the age of 60.

According to the Associated Press, the Russian health ministry said, “Batches of the Sputnik V vaccine have been distributed by the Ministry of Health and have already been sent by the supplier to the city of Moscow and a number of other regions that have reported a decrease in vaccine stockpiles.”  

In a March 13 email to FactCheck.org, Xenia Cherkaev, a postdoctoral fellow in social anthropology at the Higher School of Economics in St. Petersburg, told us that there were numerous articles in Russian media about the recent resupplies of COVID-19 vaccines.

Cherkaev said she found no mention of a demand to destroy vaccines. 

On the question of vaccine hesitancy among Russians, “People are still urged to be vaccinated, COVID is still recognized to be a problem (although it pales now, against the background of the so-called ‘special military operation’),” Cherkaev said, referring to the war in Ukraine.

Editor’s note: SciCheck’s articles correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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Associated Press. “Russia is replenishing COVID-19 vaccines, not destroying them.” 8 Mar 2023.

Baraniuk, Chris. “Covid-19: What do we know about Sputnik V and other Russian vaccines?” The BMJ. 19 Mar 2021.

Baxter, Michael. “Putin Orders Destruction of All Covid-19 Vaccines in Russia.” Real Raw News. 3 Mar 2023.

Borrell, Josep. “Vaccinating the world: between promises and reality.” European Union External Action. 19 Jun 2022.

Cherkaev, Xenia. Email to Factcheck.org. Postdoctoral fellow at the Higher School of Economics in St. Petersburg, Russia. 13 Mar 2022. 

Fraser, Terrence. “No, COVID-19 vaccines don’t cause HIV, AIDS or cancer.” AP News. 2 Nov 2021. 

Ibrahim, Noor. “Russian COVID Vaccine Creator Found Strangled to Death With Belt.” Yahoo! News. 3 Mar 2023.

Isachenkov, Vladimir and Daria Litvinova. “Scientists uneasy as Russia approves 1st coronavirus vaccine.” AP News. 11 Aug 2020.

Ivanova, Polina and Polina Nikolskaya. “Big promises, few doses: why Russia’s struggling to make Sputnik V doses.” Reuters. 14 May 2021. 

Jones, Ian and Polly Roy. “Sputnik V COVID-19 vaccine candidate appears safe and effective.” The Lancet. 2 Feb 2021.

Kier, Grace and Paul Stronski. “Russia’s Vaccine Diplomacy Is Mostly Smoke and Mirrors.” Carnegie Endowment for International Peace.” 3 Aug 2021. 

McDonald, Jessica. “Baseless Conspiracy Theories Claim New Coronavirus Was Bioengineered.” Updated 29 Jun 2021.

Our World in Data. COVID-19 Data Explorer. Russia. “Share of people who completed the initial COVID-19 vaccination protocol.” Accessed 14 Mar 2023.

Pape, Ulle. “The Silence Epidemic: Why Does Russia Fail to Address HIV?” Georgetown Journal of International Affairs. 31 Jan 2022. 

Moscow Times. “Putin Says He Took Nasal Spray Covid Vaccine.” 25 Nov 2021. 

@rightside_optics. “Soon the west will do the same.” Instagram. 6 Mar 2023.

Russian Ministry of Health. “Russian Ministry of Health sent shipments of Sputnik V vaccine…” Telegram. 5 Mar 2023.

Schneider-Kamp, Anna. “COVID-19 Vaccine Hesitancy in Denmark and Russia: A qualitative typology at the nexus of agency and health capital.” SSM Qual Res Health. 2 Dec 2022.

Twigg, Judy. “Why Aren’t Russians Getting Vaccinated?” Think Global Health. 26 July 2021. 

Ullah, Zahra and Katharina Krebs. “Putin says Russia needs to speed up vaccination for Covid-19.” CNN. 13 Oct 2021.

World Health Organization. COVAX. Accessed 13 Mar 2023.

The post Posts Spread Unfounded Claims About Russia’s Use of COVID-19 Vaccines appeared first on FactCheck.org.

SciCheck Digest

Social media posts make the unfounded claim that the Heinous Crimes Court in the Philippines issued a warrant for Bill Gates’ arrest for “‘premeditated murder’ linked to vaccine roll out.” That court no longer exists, and a spokesperson for Gates told us there is no warrant for his arrest.

Full Story 

Bill Gates and the Bill & Melinda Gates Foundation have been frequent targets of online misinformation and false claims, increasingly so since the foundation helped fund COVID-19 vaccine research. 

Now posts on social media falsely claim that a Philippine court, the Heinous Crimes Court, has issued a warrant for Gates’ arrest for “premeditated murder.” 

“Looks like the Philippines has issued an international arrest warrant for Bill Gates. Makes my heart happy,” read a Facebook post on March 4.

The claim stems from an article published March 2 on NewsPunch — a website known for spreading misinformation — with the headline, “Bill Gates Arrest Warrant Issued in Philippines For ‘Premeditated Murder’ Linked To Vaccine Roll Out.”

“The judge said Gates, as the founder of the Bill and Melinda Gates Foundation, is ‘wanted in connection with hundreds of thousands of deaths, a number which cannot be estimated at present and is certain to increase exponentially in time,’” NewsPunch said in its fabricated article.

“The Heinous Crimes Court in Manila issued the order for the arrest of Gates under article 248 of the revised penal code (RPC), which carries a minimum prison term of 20 years and one day,” the article continued.

The caption on an Instagram post sharing a screenshot of the article said: “WOAH‼️ WOAH‼️ WOAH‼️ An arrest warrant was just issued for BILL GATES?!  Yes! This is REAL.”

But the claim in the article and social media posts is not real.

We could find no record or report of a warrant for Gates’ arrest. 

A spokesperson for Bill Gates told us in an email, “The claim that a court in the Philippines has issued an international arrest warrant for Bill Gates due to the COVID-19 vaccine roll-out is false.”

And there is no heinous crimes court in the current Philippine judicial system. A chart of the Philippine court system shows no such court, according to the Supreme Court of the Philippines Public Information Office.

Anna Su, a law professor at the University of Toronto who worked as a law clerk for the Philippine Supreme Court, told us in an email, “No there is no such court.”

Heinous crimes courts did exist at one time, but were abolished in the Philippines in 2004 by the Supreme Court, in part because of safety concerns for its judges who were potential targets for defendants. Heinous crimes are now tried by regional trial courts, according to the Thirteenth Congress of the Republic of the Philippines.

There also is no record of “hundreds of thousands of deaths” due to COVID-19 vaccines in the Philippines — or anywhere else — as the NewsPunch article claims. No vaccine is 100% safe, but extensive monitoring of the COVID-19 vaccines have found only rare cases of serious adverse effects.

It’s estimated that COVID-19 vaccines have saved at least 14.4 million lives worldwide, according to a 2022 study published in the Lancet.

Globally, there have been nearly 6.9 million deaths due to COVID-19, according to the World Health Organization. There have been more than 4 million confirmed COVID-19 cases in the Philippines and more than 66,000 deaths.

As of March 5, more than 73.9 million people in the Philippines have been fully vaccinated against COVID-19, according to the National COVID-19 Vaccination Dashboard. At least one dose of the COVID-19 vaccine has been given to nearly 72% of the population, according to Johns Hopkins University of Medicine.

Editor’s note: SciCheck’s articles correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

Sources

Bill & Melinda Gates Foundation. “Bill & Melinda Gates Foundation Dedicates Additional Funding to the Novel Coronavirus Response.” 5 Feb 2020. 

Fichera, Angelo. “Video Targets Gates With Old Clip, Misleading Edit.” FactCheck.org. 5 Mar 2021. 

Supreme Court of the Philippines, Public Information Office. “Flowchart.” Accessed 9 Mar 2023. 

Hale Spencer, Saranac. “Conspiracy Theory Misinterprets Goals of Gates Foundation.” FactCheck.org. 14 Apr 2020.

Our World in Data. “Philippines: Coronavirus Pandemic Country Profile.” Accessed 9 Mar 2023.

Council of ASEAN Chief Justices. “Philippine Court System.” Accessed 9 Mar 2023. 

Schaedel, Sydney. “Fauci Didn’t Invent, Won’t Profit from Remdesivir.” FactCheck.org. 21 May 2020. 

Spokesperson for Bill Gates. Email to FactCheck.org. 9 Mar 2023. 

Su, Anna. Law professor, University of Toronto. Email to FactCheck.org. 9 Mar 2023

World Health Organization. “14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021.” 5 May 2022.

The post Posts Fabricate Charge Against Bill Gates in Philippines appeared first on FactCheck.org.

SciCheck Digest

Vaccination and infection both provide protective immunity to COVID-19, particularly against severe disease. But gaining immunity through infection is far riskier than vaccination. Posts citing a new Lancet study omit that important context and also misleadingly claim the study shows immunity after infection is superior to vaccination immunity. A co-author of the study told us there was “insufficient data to definitively state” immunity from infection is superior.

How effective are the vaccines?

Full Story

COVID-19 vaccination and infection each provide some temporary protection against future infection and stronger, longer-lasting protection against severe illness.

A recent Lancet study combined data from multiple past papers to estimate the degree and length of protection after getting COVID-19. The researchers, from the University of Washington’s Institute for Health Metrics and Evaluation, found that infection reduced the risk of reinfection, but that this protection diminished more quickly once omicron arrived in late 2021. (Before the emergence of omicron and its subvariants, there was the original virus followed by variants including alpha, beta and delta.) Protection against severe disease was high for all variants studied.

Drawing on their own data from a study that is not yet published, they also made comparisons to the immunity offered by vaccines. “Although protection from re-infection from all variants wanes over time, our analysis of the available data suggests that the level of protection afforded by previous infection is at least as high, if not higher than that provided by two-dose vaccination using high-quality mRNA vaccines (Moderna and Pfizer-BioNTech),” they wrote.

Citing the study, articles and social media posts have spread stating that immunity from infection is superior to immunity from vaccines, or that “natural immunity offers stronger protection than vaccination against COVID.”

The reality is more complicated.

First, the idea that immunity from infection is superior to immunity from vaccines exaggerates the stated conclusions in the Lancet paper. The data did not show that immunity from infection was superior to immunity from two vaccine doses, simply that it was at least equivalent, Stephen Lim, a professor of health metrics sciences who co-authored the new Lancet study, told us in an email.

Second, the study did not look at “hybrid immunity” from both infection and vaccination, which some evidence suggests is stronger than either immunity from infection or vaccination alone.

Third, COVID-19 disease and vaccination are fundamentally not comparable in certain ways. COVID-19 is a disease that has killed at least 6.8 million people, including more than 1.1 million Americans, and sickened many more. Vaccination is a safe tool people can use to reduce risk of severe disease.

“Vaccines, of course, remain the safest way to acquire immunity, whereas acquiring natural immunity must be weighed against the risks of severe illness and death associated with the initial infection,” Lim said, echoing a similar statement made in his paper.

Lancet Findings on Immunity After Infection

The Lancet paper is a systematic review and meta-analysis, which means the authors searched for previously published studies that measured protection from COVID-19 in people who had been infected and people who had not and then combined data from the papers to estimate protection. 

They found 65 studies from 19 countries, concluding that “protection against re-infection was high” when measuring reinfections with the earlier COVID-19 variants: the original virus, as well as the alpha, beta and delta versions. Protection against reinfection with omicron BA.1 — the first omicron variant — was “substantially” lower.

Over time, protection from reinfection decreased for all variants but decreased more quickly with the arrival of omicron. Using data from the 30 studies that included information on time since infection, the authors estimated that at four weeks after infection, protection from the ancestral, alpha and delta variants was around 85%, falling to a little under 79% by 40 weeks after infection. Protection against reinfection with the omicron BA.1 variant was 74% at four weeks and around 36% by 40 weeks. 

It makes sense that protection from reinfection would decline with the arrival of omicron, since it was more immune evasive and more transmissible than prior variants. Only a few studies included in the meta-analysis looked at protection against reinfection with omicron subvariants that came after BA.1, and none looked at the currently circulating XBB.1.5, making it more difficult to draw conclusions about current protection.

However, based on data from a small number of studies, protection from reinfection with omicron variants was higher if someone had a prior infection with omicron, rather than a pre-omicron variant.

Protection against hospitalization or death at 40 weeks remained high regardless of variant. Infection reduced risk of severe disease by nearly 89% for omicron BA.1 and a little over 90% for ancestral, alpha and delta.

Vaccination and Infection Both Provide Protection Against Future Disease

The primary focus of the new Lancet paper was to compare protection from past infection versus no past infection, Lim said. He and his colleagues plan to submit a separate paper soon that elaborates on the comparison between vaccines and past infection.

Lim told us that he and his co-authors concluded that past infection was at least as protective as the best mRNA vaccines, not that it was more protective. This is due to uncertainty in their estimates for the protection provided by each, he explained. “Based on the data included in our review, there is insufficient data to definitively state that there is a numerical advantage of past infection against the best mRNA vaccines,” Lim said.

Some posts and articles overstate the weakness of vaccine-induced immunity. A widely shared Defender article, for example, led to a post inaccurately claiming that “#COVID vaxx makes you MORE likely to get COVID.”

As we have written, this is incorrect. The Defender article cites a graph comparing vaccine effectiveness after three vaccine doses versus two doses but incorrectly interprets it as showing vaccine-acquired immunity eventually “became negative.”

The Defender is a publication of Children’s Health Defense, an organization run by Robert F. Kennedy Jr. that has previously spread vaccine misinformation.

Alejandro Balazs, an immunologist at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, told us in an email that vaccine effectiveness varies significantly depending on the variants circulating and a person’s particular history of COVID-19, including whether they were infected and when this happened in relation to vaccination. Because of these factors, “discussion of whether natural immunity is better than vaccines requires a level of nuance which is rarely discussed,” he said.

Regardless of which type of immunity is better or more durable, there is evidence that vaccines benefit people who have already had COVID-19.

Lim, Balazs and Daniela Weiskopf, an immunologist at the La Jolla Institute for Immunology, all said that the Lancet researchers didn’t assess immunity in people who have gotten some combination of vaccines and infections.

A review study published in the Lancet Infectious Diseases in January 2023 looked at protection against the omicron variant, comparing hybrid immunity to immunity following vaccination alone or infection alone. Hybrid immunity provided the strongest and most lasting protection against hospital admission or severe disease.

Weiskopf also said that while infection does appear to generally provide protection, there remains a small group of people who do not mount a durable immune response. It is difficult to predict who might fall into that group.

Lim said that people making decisions about primary vaccines and boosters must take into account individuals’ risks and those of their close contacts.

“For example, risk of severe disease increases dramatically with older individuals as well as those with comorbidities, e.g. those who are immunocompromised. Vaccines provide an important immunity boost for these high-risk populations,” Lim said. He added that vaccines are also important for people who have not had COVID-19 before, those who were infected with a variant prior to omicron, and those who regularly spend time with people at high risk.

COVID-19 Vaccines Are Safer Than Infection

Posts and commentators discussing immunity after infection often leave out the dangers of COVID-19 infection, or misleadingly imply that COVID-19 vaccines are unsafe. 

Speaking during a segment on Fox News that mentioned the new Lancet paper, Dr. Scott Atlas said people previously infected with COVID-19 “have biological protection that is better, not just equal, better as proven by the data from the vaccine.”

Atlas, a neuroradiologist who was a member of former President Donald Trump’s coronavirus task force and has previously spread misinformation about COVID-19, continued, “The vaccine has side effects. We still don’t have a real, accurate assessment of the side effects even though we’ve had 5 or 6 billion doses. You have to wonder why that is.”

COVID-19 vaccine side effects are mild and temporary in the vast majority of cases, and some people have no side effects. Common side effects include fever, headache, fatigue, muscle pain and pain at the injection site. Vaccine safety monitoring systems have detected only rare cases of serious side effects.

In contrast, COVID-19 infection can result in death or long-term medical issues, including heart and lung problems.

“I do not think that immunity from infection is superior based on the evidence,” Balazs said, adding that there are “considerable risks associated with COVID-19 infection, particularly in vulnerable populations. Side-effects from vaccines are rare as compared to health risks from COVID-19.”

“We know that vaccinations are increasing your antibody levels and your T cell levels without the risk of you getting sick,” Weiskopf said.

Data on Immunity After Infection Are Not New

Many social media posts and articles have focused on the idea that someone — be that the media, government or public health officials, or some unspecified group — has omitted or suppressed information about immunity after infection. Widely shared posts also include “natural immunity” on a long list of topics “they” got wrong and declare “WE WERE RIGHT ABOUT EVERYTHING!”

The idea that infection provides substantial protection from future COVID-19 is not new. Scientists have been publishing the available evidence on immunity following COVID-19 since 2020, although early on there was uncertainty about the duration and reliability of this protection. Major media outlets have covered these findings. Weiskopf pointed out that as a meta-analysis, the new Lancet study itself only draws on previous studies, meaning the data underlying its conclusions were already available.

The National Institutes of Health has promoted research it helped fund looking at immunity after infection, including research that looked into the question of whether previously infected people needed one or two primary COVID-19 vaccine doses. The CDC has also previously reviewed the strengths of immunity after infection, noting the protection afforded by prior infection while also emphasizing the benefits of hybrid immunity.

It’s true that the CDC has not always accounted for past infection in its guidance. Some experts have criticized the agency for this.

But it’s also important to recognize that early on, there was limited data on how protective immunity after infection would be, and other coronaviruses, such as those that cause colds, did not provoke long-lasting protection against reinfection. Given the uncertainties, and the possibility that some subset of people would not be very well protected, health authorities encouraged vaccination even for those who were previously infected.

The agency stated in early 2021, “Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, vaccine should be offered to you regardless of whether you already had COVID-19 infection,” explaining that it was unknown how long protection after COVID-19 would last and that immunity can vary from person to person. 

And for a while, both vaccination and previous infection were quite good at preventing not just severe disease, but another infection. Then, with the arrival of the delta variant — and even more so with the omicron variant and its subvariants — it became clear that neither vaccination nor previous infection was very protective against infection for very long, although it turned out that protection against severe disease held up well.

By that time, though, accumulating evidence pointed to the benefit of previously infected people getting vaccinated, and a first booster dose looked to be helpful in protecting against omicron, as we wrote in January 2022. Data continue to suggest that an additional shot or two can help boost and broaden the immune response, offering better protection against future variants, although experts say not everyone may need them.

Today, the CDC says, “Getting a COVID-19 vaccination is a safer and more dependable way to build immunity to COVID-19 than getting sick with COVID-19.” The agency now says people “may consider” waiting three months after a positive test or the beginning of symptoms to get their next vaccine dose. (Some experts say for individuals who are young and healthy, it’s better to wait a bit longer than that after infection for a booster.)

“The fact that the guidance evolved over the past three years is clearly a source of frustration for the public, but it reflects the changing nature of the threat and incorporated the best available information at the time,” Balazs said. “With the benefit of hindsight it is easy to criticize public health decisions, but people should consider that the facts on the ground kept changing as the pandemic evolved, so the science changed with it.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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