SciCheck Digest

Numerous studies have found that additional COVID-19 shots are generally associated with extra protection against the coronavirus. Many people on social media, however, have shared a preliminary finding from a Cleveland Clinic study and misrepresented it as proving that getting more doses increases a person’s risk of infection.

How effective are the vaccines?

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COVID-19 vaccines and boosters reduce the risk of severe disease and death. They also offer some protection against infections, although the effectiveness wanes in the months after getting vaccinated, and such effectiveness is lower against the omicron variant, compared with earlier variants of the coronavirus.

An observational study of more than 50,000 Cleveland Clinic staff published recently in Open Forum Infectious Diseases aimed to assess the effectiveness of the bivalent omicron booster against infection between September 2022 and March 2023, a period when 8.7% of the employees tested positive. It concluded the booster provided some protection. The bivalent booster prompts the immune system to recognize both the original spike protein of the virus and the version found on BA.4 and BA.5, the predominant omicron subvariants when it was first rolled out. 

The researchers also noticed that people who got more vaccine doses prior to Sept. 12, 2022 — the day the bivalent booster became available at the Cleveland Clinic — had a higher rate of testing positive in the following months than people who had gotten fewer prior vaccine doses. But the researchers didn’t find that more doses caused a higher risk of infection. Rather, this finding was an association that could be due to multiple other factors. And studies have generally found that each additional vaccine dose reduces COVID-19 risk.

Incorrect claims about the paper have been circulating since before it was peer-reviewed and published. Recently, a widely viewed social media post jumped to the conclusion that the study shows that “a higher number of COVID-19 vaccine doses received increases the risk of infection with COVID-19.” Another widely viewed post sharing the study results incorrectly concluded that the vaccines were a “failed experiment.”

The original COVID-19 vaccine series was initially very effective against infection and without question “saved a lot of lives,” co-author Dr. Nabin Shrestha, an infectious disease physician at the Cleveland Clinic, told us. Determining whether getting more doses of the COVID-19 vaccines can later cause greater susceptibility to infections “wasn’t the point of the study,” he said. 

Shrestha said he did not know the explanation for the findings. The paper mentions immunological mechanisms that “have been suggested as possible mechanisms whereby prior vaccine may provide less protection than expected.” But Shrestha said that the result could also be from a confounding factor — some characteristic of people who got more vaccines that led them to have a higher number of positive tests.

The study said: “The unexpected finding of increasing risk with increasing number of prior COVID-19 vaccine doses needs further study.”

Outside experts doubted that the prior vaccines increased infection risk.

“The data from the study do indeed show that those who have more vaccines have more infections, but this is very unlikely to be causal in nature,” epidemiologist Matthew Fox from Boston University told us in an email.

Deepta Bhattacharya, a professor of immunobiology at the University of Arizona College of Medicine, told us via email that the immunological mechanisms mentioned in the paper don’t make “a lot of sense as far as explaining the authors’ results.” He also pointed out that the study is observational — meaning the researchers looked back at data available on Cleveland Clinic staff members rather than randomly assigning people to particular interventions. 

“There are all sorts of confounding variables that can’t all be accounted for (e.g. behavioral differences between groups),” he said. “When the conclusions of an observational study are clearly at odds with the mechanistic immunology, I certainly have doubts about its conclusions.”

“There is no clear or compelling evidence that repeated vaccination with COVID-19 vaccines makes anyone more susceptible or prone to getting COVID-19,” a Centers for Disease Control and Prevention spokesperson told us in an email. “The continued use of COVID-19 vaccines among the worldwide population, as well as clinical trial data, show these vaccines are highly effective in preventing the most severe outcomes from a COVID-19 infection including hospitalization and death.”

Findings Have Multiple Possible Explanations

Observational studies like the Cleveland Clinic one can turn up associations between things, but it can be difficult to assess what caused these patterns.

Shrestha said the finding in his study on prior doses and infection risk “should certainly give us some pause.” But he also said that “a study like this, one study, is not going to prove any cause-effect relationship.” The goal in presenting the findings, he said, was to prompt other researchers to also look at the relationship between past doses and infection risk.

Fox said that people who do not get vaccines are “typically not the same” as people who do, and these differences could make one group more likely to get infected or get a positive COVID-19 test. Vaccines were readily available to staff members, according to the paper, and the decision on whether to get them was voluntary. 

Researchers can try to make statistical adjustments for differences between groups, but Fox pointed out that the main graph in the paper showing the relationships between prior vaccine doses and COVID-19 risk — which was shared widely — is unadjusted. He also mentioned that there was no table showing the characteristics of people with different numbers of prior vaccine doses, and that this data is typically helpful for making sure there are proper adjustments for any differences.

Shrestha said he and his co-authors would not have shared the unadjusted graph had they not concluded in the main adjusted analyses that the association held up. But as we said, he agreed there could be some confounding factor explaining the results.

One typical difference, Fox said, is that people who do not get vaccines may be less likely to seek out testing if they get infected. This could make it look like people with fewer vaccines were at lower risk of infection when they really weren’t. 

People were considered to have been infected if they had a positive PCR test result, Shrestha said. He added that there were certainly missed infections, although the researchers found a similar rate of PCR testing regardless of the number of prior doses. 

The study did not include data on at-home tests. The researchers said workers were required to test positive with PCR tests to take time off work for COVID-19, which may have lessened the number of people who only relied on at-home tests.

The researchers also mentioned that time since employees were last infected may have confounded the results, since people who had been more recently infected were at lower risk of COVID-19.

Vaccination lowers infection risk, but only for a time — so it’s possible people with fewer vaccinations were more likely to have been infected more recently, thereby protecting them during the study period.

Fox said that people who got fewer vaccines could be younger and healthier, although the relative youth of the employees may have mitigated this factor. Younger or healthier people could be less prone to getting sick and less likely to get tested if they were sick. The researchers did not adjust anywhere in the paper for whether the participants had various illnesses other than COVID-19, Fox said. 

And it is not possible to adjust for exposure to the virus, he added. The researchers wrote that people who got fewer than three vaccine doses could have been “more likely to exhibit risk-taking behavior,” but Fox said that it’s possible people who get vaccinated are more exposed to the virus than those who are not.

COVID-19 Vaccines Reduce Infection Risk

The aim of the COVID-19 vaccine program is to protect against severe disease, according to the CDC, and the vaccines are accomplishing this. But as we’ve said, the vaccines have also provided some protection against getting sick at all.

The initial clinical trials of the Pfizer/BioNTech and Moderna vaccines, of course, showed a reduction in symptomatic COVID-19 of more than 90%, and boosters also reduced symptomatic COVID-19. 

“When clinical trials have been run on boosters, a marked increase in efficacy has been observed,” Bhattacharya said. Protection against COVID-19 has fallen with the arrival of the omicron variants, he said, “but it is really hard to think of a plausible immunological mechanism that would make the booster shots worse than not having them.”

The Cleveland Clinic study found that getting the bivalent booster was associated with a 29% reduction in risk of getting BA.4 and BA.5 — the omicron subvariants the booster targeted. It had an effectiveness of 20% for the next set of variants, the BQ family of subvariants. The study did not find protection against testing positive for infections with the currently dominant XBB family.

Assessments of vaccine effectiveness against XBB viruses have been mixed. A CDC study, for instance, showed similar effectiveness of the bivalent vaccine against BA.5 and XBB subvariants.

“I do think we would expect reduced effectiveness with different strains, but I doubt that it is this low,” Fox said of the Cleveland Clinic study findings. 

Regardless, the study certainly did not show that getting vaccinated increased infection risk.

No Confirmed Negative Immunological Impacts from Boosters

A more complicated question is whether vaccine doses directed at one version of the virus could eventually lead to a less optimal immune response to other variants.

The theoretical concern, as we’ve explained in past articles, is that the immune response may become too focused on an element of an older version of the virus, reducing future flexibility to respond to new variants. This could have implications for decisions on how often to recommend boosters and what versions of the virus to boost against.

But analyses of immune responses to the original boosters didn’t show signs of this narrowing. There is also evidence the bivalent booster broadens immunity, leading to activity directed at newer forms of the virus, according to a recent review paper published in Immunity by Marios Koutsakos from the University of Melbourne and Ali Ellebedy from Washington University in St. Louis. 

In addition, “clinical and epidemiological studies support the notion that any prior exposures to SARS-CoV-2 by infection and/or vaccination have a positive impact in mitigating disease severity of subsequent infections,” they wrote. 

A May 18 statement from a World Health Organization advisory group on vaccine composition said there is evidence from laboratory work that prior exposures to COVID-19 or vaccines may reduce certain immune cells’ response to new parts of a variant. “However, based on observational epidemiological studies to date, the clinical impact remains unclear,” the statement says.

Some studies found that the bivalent and original boosters led to similar levels of neutralizing antibodies against omicron subvariants, leading researchers to suggest that immune memory from prior exposures to the original vaccines helps explain the lack of a superior response to the updated boosters.

Bhattacharya said there is evidence that the immune system prefers “to rapidly respond first to parts of the virus that have not mutated or changed relative to the vaccine.”

But this isn’t harmful. “Study after study has shown that this type of response markedly enhances protective antibodies,” he said. “To the extent that these antibodies clear the virus out quickly, there can be a suppression of new immune responses to the mutated parts of the virus, but this is only because the virus is gone. The immune system is thus responding in proportion to need.”

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.

Sources

“Frequently Asked Questions about COVID-19 Vaccination.” CDC website. Updated 15 May 2023.

Link-Gelles, Ruth et al. “Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Preventing Symptomatic SARS-CoV-2 Infection Attributable to Omicron BA.5– and XBB/XBB.1.5–Related Sublineages Among Immunocompetent Adults — Increasing Community Access to Testing Program, United States, December 2022–January 2023.” Morbidity and Mortality Weekly Report. 3 Feb 2023.

Wu, Nana et al. “Long-Term Effectiveness of COVID-19 Vaccines against Infections, Hospitalisations, and Mortality in Adults: Findings from a Rapid Living Systematic Evidence Synthesis and Meta-Analysis up to December, 2022.” The Lancet Respiratory Medicine. 10 Feb 2023.

Shrestha, Nabin K. et al. “Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine.” Open Forum Infectious Diseases. 19 Apr 2023.

McDonald, Jessica. “Q&A on Omicron-Updated COVID-19 Boosters.” FactCheck.org. 23 Sept. 2022.

“Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose.” FDA news release. 31 Aug 2022.

Robertson, Lori. “Studies Show Boosted Immunity Against Omicron with Booster Doses.” FactCheck.org. 28 Jan 2022.

McDonald, Jessica. “COVID-19 Booster Enhances Protection, Contrary to ‘Immune Fatigue’ Claims.” FactCheck.org. 4 Feb 2022.

The Gateway Pundit (@gatewaypundit). “groundbreaking study conducted by the renowned Cleveland Clinic, ranked as the second-best hospital in the world, has found that a higher number of COVID-19 vaccine doses received increases the risk of infection with COVID-19 …” Instagram. 11 Jun 2023.

Jimmy Dore (@jimmy_dore). “FYI: It’s not a vaccine. It’s a failed experiment. We were the guinea pigs.” Twitter. 30 May 2023.

Shrestha, Nabin K. et al. “Effectiveness of mRNA COVID-19 Vaccines among Employees in an American Healthcare System.” medRxiv. 5 Jun 2021.

Aronson, JK et al. “Confounding.” Catalogue of Biases. 2018.

McDonald, Jessica. “Vaccinated People Not More Susceptible to COVID-19 Than Unvaccinated.” FactCheck.org. Updated 23 Jan 2023.

Hoft, Jim. “Cleveland Clinic Peer-Reviewed Study Found That the More Vaccines You’ve Had, the Higher Your COVID-19 Infection Risk.” The Gateway Pundit. 3 Jun 2023.

⌘ ⌘ MrsPitbull ⌘ ⌘ (@MrsPitbull). “🚨🚨🚨 BREAKING: Cleveland clinic study which found that “The higher the number of vaccines previously received, the higher the risk of contracting COVID-19” has been peer review published. …” Twitter. 29 May 2023.

“Overview of COVID-19 Vaccines.” CDC website. Updated 23 May 2023.

McDonald, Jessica. “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine.” FactCheck.org. Updated 21 Apr 2023.

McDonald, Jessica. “A Guide to Moderna’s COVID-19 Vaccine.” FactCheck.org. Updated 21 Apr 2023.

“COVID Data Tracker – Variant Proportions.” CDC website. Updated 9 Jun 2023. 

“Statement on the Antigen Composition of COVID-19 Vaccines.” World Health Organization website. 18 May 2023. 

McDonald, Jessica. “Q&A on Second COVID-19 Boosters for Older People.” FactCheck.org. Updated 23 May 2022.

Koutsakos, Marios and Ellebedy, Ali H. “Immunological Imprinting: Understanding COVID-19.” Immunity. 19 Apr 2023.

Wang, Qian et al. “Antibody Response to Omicron BA.4–BA.5 Bivalent Booster.” New England Journal of Medicine. 9 Feb 2023.

Collier, Ai-ris Y. et al. “Immunogenicity of BA.5 Bivalent mRNA Vaccine Boosters.” New England Journal of Medicine. 9 Feb 2023.

Offit, Paul A. “Bivalent Covid-19 Vaccines — A Cautionary Tale.” New England Journal of Medicine. 9 Feb 2023.

The post Cleveland Clinic Study Did Not Show Vaccines Increase COVID-19 Risk appeared first on FactCheck.org.

The federal public health emergency for COVID-19 ended on May 11, bringing changes to health care and public benefits. In this video, FactCheck.org teamed up with Factchequeado to answer some questions about how this might affect you.

The end of the public health emergency is not the end of all pandemic-related benefits, so many people won’t feel a difference immediately, as Anne Sosin, a policy fellow studying rural health equity at the Nelson A. Rockefeller Center at Dartmouth, told us.

Overall, the “widest ranging impact” directly resulting from the end of the public health emergency, according to KFF, is the rise in the cost of COVID-19 tests. People on Medicaid can still get free at-home tests through September 2024, but the tests are no longer covered by insurers for most other people.

The cost of vaccines and treatments won’t change immediately. However, the government supply of vaccines is only expected to last through the summer or early fall.

Many of the telehealth benefits for people on Medicaid and Medicare were made permanent or extended until the end of 2024.

For more details, see our story “Q&A on the End of the COVID-19 Public Health Emergency,” which, like the video, is available in English and Spanish.

This video is the first in a series of videos that will be jointly produced by FactCheck.org and Factchequeado, a media outlet that counters Spanish-language misinformation in the U.S. Latino community, to provide accurate information on health issues. 

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 Video: Q&A on the End of the COVID-19 Public Health Emergency appeared first on FactCheck.org.

SciCheck Digest

Human coronaviruses first identified in the 1960s cause common colds. But a viral video misrepresents early research on common coronaviruses and cites unrelated patents to falsely suggest U.S. scientists created the viruses that cause SARS and COVID-19. The video also is not footage of official testimony before the European Parliament.

What do we know about the origins of SARS-CoV-2?

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Scientists have been studying coronaviruses, a family of viruses that infect animals and humans, for decades — the first was identified in chickens in the 1930s. In 1968, after the first human coronavirus was identified in 1965, virologists grouped them and named them coronaviruses for their crown-like surface, which also resembles the outermost layer of the sun called the corona (corona is the Latin word for crown). 

Seven coronaviruses are known to infect humans — four of them, known as common human coronaviruses (229E, NL63, OC43 and HKU1), generally cause mild to moderate symptoms of a common cold. But coronaviruses got more attention in 2003, after the emergence of SARS-CoV-1, the first coronavirus known to cause a severe respiratory illness in humans, followed by MERS-CoV in 2012, and SARS-CoV-2, which causes COVID-19, in 2019.

Both SARS-CoV-1 and MERS-CoV originated in animals and jumped to humans. Although there is still no proof of how SARS-CoV-2 started, many scientists think the available evidence also points to a zoonotic spillover. If SARS-CoV-2 did escape from a lab in Wuhan, there is a general consensus that it was an accident. A U.S. Intelligence report released in 2021 showed that all agencies agreed that “the virus was not developed as a biological weapon” and “most” said the virus “probably was not genetically engineered,” as we reported.

Yet, in a widely shared video misleadingly presented as testimony to the European Parliament, David Martin, a financial analyst, cited unrelated patents and distorted early research on coronaviruses to falsely suggest that scientists in the U.S. created the viruses that cause SARS and COVID-19 as part of a plot to drive vaccine profits.

“Ladies and gentlemen, this was premeditated domestic terrorism,” he said of the COVID-19 pandemic (mark 19:22). “This is an act of biological and chemical warfare perpetrated on the human race. … [T]his was a financial heist and a financial fraud,” he added — a quote that was later shared in a Twitter post that has been retweeted more than 75,000 times.

Except Martin’s entire argument is bunk. Dr. Susan R. Weiss, a coronavirus researcher at the University of Pennsylvania, told us in a phone interview that his statements are full of inaccuracies and completely distort past coronavirus research.

“There is no basis for any of this,” she said. “It makes no scientific sense.”

Martin has pushed several conspiracy theories about the pandemic. In 2020, he was a central figure in the second “Plandemic” video, which also falsely claimed that the pandemic was planned, as we’ve written.

Not European Parliament Testimony

Part of the appeal of Martin’s video — and lending false legitimacy to his claims — is that at first glance, it appears he is speaking in front of the European Parliament and giving official testimony.

“[C]ant believe my ears, what is being said at the europian union,” a Facebook user said, sharing the video, which shows Martin next to a European Parliament flag in what might look to someone like the European Parliament Hemicycle.

“Must watch: This is the opening presentation by Dr David Martin on the origins of Covid in 1965 & Covid Vaccines in 1990!” a Twitter user wrote. “He speaks in front of the European Parliament International Covid Summit III in Brussels on May 3, 2023. Hear and be shocked..!” 

In reality, only five of the 705 members of the European Parliament participated in the event, which took place in a room of the parliament’s building in Brussels, as part of a three-day meeting organized by COVID-19 skeptics and anti-vaccination activists. The five Parliament members have participated in actions opposing COVID-19 vaccines.

Natalie Kontoulis, a press officer for the European Parliament, told us in an email that the meeting “was not an official European Parliament event.” She added, “Members of the Parliament can exercise their mandate freely and bear responsibility for both their activities and their content.”

According to the event’s website, the speaker line-up included some prominent COVID-19 misinformation spreaders, including Dr. Robert Malone, Dr. Pierre Kory, and Dr. Ryan Cole. The event content was turned into a book called “ICS 3 – The Whole Truth” and commercialized — a paperback copy sells for $29.99.

SARS-CoV-2 is New, Not Engineered for 56 Years  

During the almost 22-minute video, Martin spins a scientifically impossible story that suggests that SARS-CoV-2 and other viruses are the result of experimentation with common cold coronaviruses that were discovered in the 1960s.

“This is actually something that’s been long in the making,” he said of the COVID-19 pandemic (mark 5:31). “In 1967, the year I was born, we did the first human trials on inoculating people with modified coronavirus. Isn’t that amazing? 56 years ago — the overnight success of a pathogen that’s been 56 years in engineering.”

But Martin, who misleads throughout by implying all coronaviruses might be the same, is misrepresenting a study that involved infecting people with a coronavirus that causes a cold. The virus had not been modified. More important, the notion that a common coronavirus could have been manipulated or engineered to create SARS-CoV-2 is incorrect.

“They’re too different,” Weiss said. “We don’t have the ability to turn one into the other.”

About a minute later, he said, “Ironically, the common cold was turned into a chimera in the 1970s. And in 1975, 1976, and 1977 we started figuring out how to modify coronavirus by putting it into different animals, pigs and dogs.”

“That doesn’t make any sense,” Weiss told us. 

First, as we said, there are multiple kinds of coronaviruses. Some infect animals and others infect humans — and a few can cross from one species to another one, Weiss told us. “It turns out, the human virus … at least the cold virus, as far as I know, only replicates in humans.” The viruses couldn’t be genetically modified at that time, either, she explained. “We couldn’t engineer viruses at that time,” she said of the 1970s, since the technology to do it, such as cloning, didn’t yet exist. 

Martin continues to mislead by saying the inoculation of those supposedly modified common coronaviruses created a huge problem in the pig and dog industry, which led Pfizer to patent its “first spike protein vaccine” in 1990. “Isn’t that fascinating? Isn’t it fascinating that we were, we were told that, ‘Well, the spike protein is a new thing,’” he said (mark 7:44).

Except, that patent was for a canine coronavirus vaccine, which targets an entirely different virus from SARS-CoV-2. In 2020, we debunked related claims that also confused canine coronavirus with the virus that caused the pandemic.

Moreover, scientists have never said that coronavirus spike proteins are “new.” The specific SARS-CoV-2 spike was new, and the genetic sequence was needed to design the vaccines. But one reason why the COVID-19 vaccines could be made so rapidly is because scientists already knew the virus’s spike proteins would be good vaccine targets. The existence of that previous knowledge is not evidence that SARS-CoV-2 was created as a bioweapon or as part of a ploy to sell vaccines.

Martin also falsely claims that SARS-CoV-1 was created in an American lab.

“Are you suggesting that SARS … might have come from a laboratory in the University of North Carolina Chapel Hill? No, I’m not suggesting it. I’m telling you that’s the facts — we engineered SARS,” he said. “SARS is not a naturally occurring phenomenon. The naturally occurring phenomenon is called the common cold … SARS is the research developed by humans weaponizing a life system model to actually attack human beings.”

There is no evidence SARS-CoV-1 was engineered or came from any lab. The virus naturally appeared in 2002 in China, when it likely jumped from civets to humans, and its origins are linked to bats.

Martin pointed to a 2002 patent as supposed proof. But the patent, which is for a method for creating viral vectors, focuses on a pig coronavirus (viral vectors are used to deliver genetic information to cells). As before, the patent is not evidence that the SARS virus was engineered.

Martin also distorted the meaning of a line of the patent that says the method could help produce “an infectious, replication defective, coronavirus particle.”

“Listen to those words: infectious replication defective,” Martin said suggestively (mark 10:18). “What does that phrase actually mean for those of you not familiar with language? Let me unpack it for you. Infectious replication defective means a weapon. It means something meant to target an individual but not have collateral damage to other individuals.” 

But he’s wrong again. Replication-defective simply means that a viral particle would be incapable of replicating itself.

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.

Sources

Payne, Susan. “Family Coronaviridae.” Viruses. 1 Sep 2017. 

“Virology: Coronaviruses.” Nature. Vol. 220. 16 Nov 1968. 

“Coronavirus: Detailed taxonomy.” AVMA.  Accessed 13 Jun 2023. 

“Human Coronavirus Types.” CDC. Updated 15 Feb 2020.

“Common Human Coronaviruses.” CDC. Updated 13 Feb 2020.

“Severe Acute Respiratory Syndrome (SARS).” CDC. 6 Dec 2017.

“Middle East Respiratory Syndrome (MERS).” CDC. Updated 2 Aug 2019

Spencer, Saranac H., et al. “New ‘Plandemic’ Video Peddles Misinformation, Conspiracies.” FactCheck.org. Updated 29 Jun 2021. 

Weiss, Susan R. Vice Chair, Department of Microbiology, University of Pennsylvania. Phone interview with FactCheck.org. 5 Jun 2023. 

Malone, Robert. “Videos: The International Covid Summit III in the European Parliament, Brussels.” Substack. 15 May 2023. 

Alexander, Lorraine K., et al. “An Experimental Model for Dilated Cardiomyopathy after Rabbit Coronavirus Infection.” The Journal of Infectious Diseases. Vol. 166. 1 Nov 1992.

Kontoulis, Natalie. Press officer for the European Parliament. Email sent to FactCheck.org. 9 Jun 2023. 

Curtis, Kristopher, et al. “Methods for Producing Recombinant Coronavirus.” International Patent Number WO 02/086068 A2. 31 Oct 2002. Robertson, Lori. “Still No Determination on COVID-19 Origin.” FactCheck.org. 20 Mar 2023.

The post Video Distorts Early Coronavirus Research To Promote Baseless Bioweapon Conspiracy Theory appeared first on FactCheck.org.

SciCheck Digest

Clinical trial data for Pfizer’s maternal vaccine to protect babies from RSV support the vaccine’s safety and efficacy, according to a vote by an FDA advisory committee. The FDA could soon approve the vaccine. But a popular social media post makes misleading claims about the trial findings.

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Respiratory syncytial virus, or RSV, causes a mild cold for most people, but infants – particularly young and premature babies – can experience severe infections. However, a vaccine to protect young babies could soon get approval by the Food and Drug Administration.

Building on a scientific breakthrough in the study of RSV about a decade ago, Pfizer has developed a maternal vaccine, to be given to pregnant people so that the antibodies they develop can be passed on to their babies. The results of the clinical trial, published in the New England Journal of Medicine, 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 and an efficacy of 69.4% through 180 days after birth.

The vaccine is the same formulation as Pfizer’s RSV vaccine for older adults, who also are susceptible to serious and dangerous illness from the virus. The FDA approved the vaccine for adults age 60 and older on May 31, but it must separately consider the data on administering the shot in pregnant people to protect babies. On May 18, an FDA advisory committee voted affirmatively that the trial data supported the effectiveness and safety of the vaccine. The FDA’s decision on whether to approve it is expected to come in August, Pfizer said.

As we’ve explained in a Q&A article, RSV infects nearly all kids by the time they’re 2 years old, the Centers for Disease Control and Prevention says. In addition to young and premature babies, infants with heart or lung disease, or weakened immune systems are particularly prone to severe illness. Dr. Mary T. Caserta, a professor of pediatrics at the University of Rochester Medical Center and a member of the American Academy of Pediatrics’ Committee on Infectious Diseases, told us the virus “is the most commonly identified cause of lower respiratory tract disease (pneumonia and bronchiolitis)” in infants. And “RSV bronchiolitis is the single most common cause of hospitalization in the first year of life in the US,” she said in an email.

Given the volume of misinformation that has circulated on social media regarding the COVID-19 vaccines, it may not be surprising that posts are beginning to appear questioning the safety of the RSV vaccine. One popular post, from a social media account that frequently posts about vaccines, raised “concerns,” but some of its claims are misleading or require more context.

Safety Data

One slide in the Instagram post listed percentages for adverse events reported in Pfizer’s clinical trial after vaccination, but it didn’t explain that the percentages were similar for those in the placebo group. And these adverse events are any health events that occur after vaccination, not necessarily events caused by the vaccine.

The peer-reviewed trial results said: “No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively).”

Bar graphs published with those results show the percentages were also similar for events considered “serious” or “severe.” (Similar bar graphs were part of a Pfizer presentation to a CDC advisory board. See slides 19 and 20.)

Natalie Dean, assistant professor in the Department of Biostatistics & Bioinformatics at the Emory University Rollins School of Public Health, told us that people, and particularly pregnant women, can have adverse events — regardless of whether they received a vaccine. “There’s a lot going on in their health,” she said. “A big strength of randomized trials is that we can separate out how often do these things happen at baseline for a placebo group … and then compare that with the vaccination group.” That comparison can “disentangle if there was any increase in adverse events that can be attributed to the vaccine.”

The phase 3 trial enrolled nearly 7,400 pregnant participants in 18 countries, with half receiving the vaccine and half getting the placebo; 45% of participants were in the United States. For the infants, 7,128 continued with the study and are being followed for up to 24 months of age.

There were very few adverse events that were considered to be related to the Pfizer vaccine. The FDA briefing document on the vaccine said that within 30 days after vaccination, 0.4% of adverse events reported in the vaccine group and 0.1% of adverse events in the placebo group were considered to be related to the injection by the investigator.

There were two adverse events from delivery through 1 month later that were “possibly” related to the vaccine, the briefing document said. One was eclampsia, or seizures that can occur in pregnancy, 15 days after vaccination, and the other was one premature delivery that resulted in a normal birth. Since there was no other cause for the premature delivery, the investigator leading the study said it would be “handled as related to” the vaccine.

Three other serious adverse event cases that occurred in the vaccination group through six months after delivery were considered to be related by the investigator: “[s]evere pain in multiple extremities,” which was resolved six days later; premature labor, which resolved in a day and resulted in a full-term pregnancy; and a case of lupus, with thrombocytopenia, a condition of low platelet count in the blood, attributed to the lupus.

For the infants, no serious adverse events “were considered related to maternal vaccination,” the briefing document said. But in one case of an infant death, the investigator assessed that it wasn’t related to vaccination while the FDA was “unable to exclude the possibility of the extreme prematurity and subsequent death being related.”

In all, there were five infant deaths (0.1%) in the vaccine group and 12 (0.3%) in the placebo group.

Preterm Births

In its briefing document, the FDA said there was a “numerical imbalance of 1%” in premature births between the vaccine and placebo groups, noting that the difference was not statistically significant. In the vaccine group, 5.7% of participants had a preterm birth, compared to 4.7% of the placebo group.

The difference for low birth weight also wasn’t statistically significant: 5.1% in the vaccine group and 4.4% in the placebo.

The Instagram post described this as “about 20% more preterm babies and low birth weight babies” in the vaccine group. There is a 20% difference between the two groups for the number of preterm births, but the figure requires context.

As we said, the difference for preterm births wasn’t statistically significant, though the FDA indicated its advisory committee — the Vaccines and Related Biological Products Advisory Committee — could discuss the imbalance in its May 18 meeting, which the committee did.

The rates of preterm birth in the trial were lower than the background rate of 10% of all births globally for 2020.

One premature birth was assessed to be “possibly related” to the vaccine. That’s the case mentioned above, in which the infant had “a normal birth outcome and no complications,” the FDA said. And, as we said, the FDA was “unable to exclude the possibility” that prematurity and the subsequent death of another infant were related to the vaccine.

About 90% of the preterm births in both the vaccine and placebo groups occurred at 34 to 37 weeks’ gestation (a full pregnancy is 38 to 42 weeks). That means most of the preterm births were only mildly premature, or what’s called “late preterm.” For what’s considered “extremely preterm birth,” which is less than 28 weeks, there was one infant in the vaccine group and one in the placebo.

The FDA advisory committee did discuss the preterm birth imbalance. While the vote was unanimous that the data supported the effectiveness of the vaccine, the vote was 10-4 on whether the data supported the safety. The committee members who voted “no” expressed concern about the data not providing enough certainty on whether the imbalance in preterm births was a safety issue.

One reason for the concern is that another pharmaceutical company, GSK, had voluntarily halted clinical trials of its maternal vaccine candidate due to an imbalance in preterm births. That imbalance wasn’t statistically significant in high-income countries in the trials, but it was in low- and middle-income countries, as we’ve written.

In the advisory committee meeting, Dr. Paul A. Offit, a vaccine expert and pediatrician at the Children’s Hospital of Philadelphia, asked 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 in favor of the data supporting the safety of the vaccine noted that the imbalance in Pfizer’s trial wasn’t statistically significant.

Vaccine Doesn’t Contain the Virus

The Instagram post also highlighted a description of the placebo from the FDA briefing document that said the placebo was similar to the vaccine formulation “minus the active ingredients.” The post pointed to those words and misleadingly commented, “basically everything but the virus.”

It’s possible some may wrongly conclude from the post that the vaccine could infect people with the virus. It can’t.

Pfizer’s RSV vaccine is a protein subunit vaccine, which uses part of a protein of a virus, not the whole virus. Other vaccines, including those for hepatitis B and pertussis, are also protein subunit vaccines.

The RSV vaccine 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 in the body, but this fragment can’t cause RSV disease.

Pfizer’s vaccine, as well as other RSV vaccines, including one from GSK that also has been approved for older adults, target the pre-fusion F protein, thanks to scientific research published in 2013 by a team of scientists at the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. The scientists were able to stabilize the pre-fusion form of the virus’s F protein, which the virus uses to enter human cells, and determined that targeting that form — as opposed to the post-fusion form the protein takes once it fuses with cells — produced highly protective antibody responses.

Another option for protecting babies from RSV illness is also being evaluated by the FDA this year. A monoclonal antibody from Sanofi and AstraZeneca would be given as a single shot to newborns or infants before their first RSV season. The drug, which targets the pre-fusion F protein, was approved by the European Commission in 2022.

Vaccine Efficacy

The FDA’s advisory committee — VRBPAC by its acronym — is made up of experts in infectious diseases, immunology, pediatrics, biostatistics and epidemiology. Those experts voted unanimously, 14-0, that the clinical trial 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. 

But a slide in the Instagram post featured a quote from a cardiologist, Dr. Peter McCullough, suggesting the data weren’t sufficient to show the vaccine was effective. McCullough, who has made false and misleading claims about the COVID-19 vaccines, first made these comments to a publication of Children’s Health Defense, a group that has spread vaccine misinformation and was founded by Robert F. Kennedy Jr. (Kennedy has taken a leave of absence from his position as chairman of the group to run for president of the United States.)

McCullough said the trial showed “only theoretical efficacy in babies” and that “less than 2% of infants at any time point contracted RSV.”

The trial didn’t measure all cases of RSV, but rather those that required medical attention from a health care provider and included rapid breathing, low blood oxygen and/or chest indrawing (see slide 24). Up to 180 days after birth, 2.5% of all infants in the trial had such a case of medically attended RSV.

In the vaccine group, 57 infants had medically attended RSV lower respiratory tract disease, compared with 117 cases in the placebo group. Those figures show an efficacy of 51.3%, meaning the vaccine cuts the risk of such disease by more than half.

The trial also measured cases of severe illness, which included more severe symptoms during a medically attended visit, being given mechanical ventilation or supplemental oxygen therapy, and certain ICU admissions. At 180 days, there had been 19 cases in the vaccine group and 62 in the placebo group, for an efficacy of 69.4%. At 90 days after birth, efficacy was even higher — 81.8%. (These figures are in Table 7 and 8 of the FDA briefing document.)

The case numbers might sound low to the general public, but they are sufficient to show vaccine efficacy — and scientists don’t expect to see very large figures in a trial, Dean, the biostatistician at Emory University, told us.

“We give vaccines to healthy people to prevent events that we hope are rare,” Dean said, and that’s why clinical trials need to enroll a lot of people. “We know the event itself is rare. But we just need to observe enough data to tell that the differences in rates of disease are real between the groups.”

The numbers may seem small, “but they’re big enough for statistics,” Dean said.

In his quote, McCullough also said RSV in infants is “uncommon,” “low-risk” and “easily treatable with nebulizers.”

But RSV is common in children and “causes a significant burden of disease,” Caserta, the American Academy of Pediatrics committee member, told us. While many infants will only have a cold from RSV, it can be dangerous for some.

As we said, the CDC says nearly all children will get RSV by the time they’re 2. Caserta also said studies have shown that over half of kids are infected by the age of 1.

Dr. Rebecca Schein, a pediatric infectious disease specialist with Michigan State University and an assistant professor at the university, noted that RSV “was part of the so-called triple demic that was filling hospitals last fall.” She told us: “RSV epidemics occur every fall and result in huge numbers of hospitalizations.”

The CDC estimates that 58,000 to 80,000 children under 5 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. There are half a million emergency department visits and 1.5 million visits to outpatient clinics for kids under 5 each year. Deaths are “uncommon” in the U.S. — an estimated 100 to 500 each year for kids under 5, though the CDC says RSV-associated deaths are likely undercounted due to a lack of testing. In lower-income countries, death in infants is more of a concern; an estimated 45,700 babies up to 6 months of age worldwide died due to RSV in 2019, according to a systematic analysis of hundreds of studies published in the Lancet.

In addition to preventing hospitalizations and deaths from RSV through vaccination, “the bigger goal is to improve overall lung health of infants,” Dr. Barney S. Graham, a professor at Morehouse School of Medicine who was one of the leaders of the NIAID team that found the breakthrough on the RSV F protein, told Science in November. “If they’re infected with RSV very early in life and develop severe disease, that affects their lung development and overall lung health probably for their lifetime. So the goal here is to really improve overall lung health and that is something that’s hard to calculate until you’ve seen it evolve over several years.”

As for using a nebulizer, which changes liquid medicine into a mist that can be inhaled, Caserta said that a variety of nebulized treatments had been studied to relieve RSV symptoms, but “no clear benefit for preventing hospitalization or reducing hospital stay has been uniformly demonstrated.”

“There is no specific therapy for RSV infection,” she said. “Supportive care with oxygen and IV fluids as needed are the most common interventions used for hospitalized infants.”

Schein said that albuterol “is the most common nebulized medication and is used to treat asthma.” Its use in treating RSV “is minimal and only useful in infants with a predisposition to asthma.”

Finally, McCullough said that “[w]idespread use” of the RSV vaccine “can be expected to cause fetal loss in some unfortunate women,” but the clinical trial didn’t include any fetal losses due to vaccination.

In the trial, there were 10 fetal deaths in the vaccine group and eight in the placebo group, the FDA briefing document said. These were due to “various clinical conditions and presentations.” The FDA agreed with the assessment of the study investigator that none was related to the vaccine, “based on review of available case narratives and evident lack of temporal relation of vaccination to the fetal loss events.”

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 Instagram Post Misleads About Pfizer’s RSV Maternal Vaccine appeared first on FactCheck.org.

For decades, an unassuming government vaccine safety surveillance system has done its job, quickly flagging possible side effects and allowing scientists and regulators to investigate further. 

But for nearly as long, the ​​Vaccine Adverse Event Reporting System, or VAERS, has also been exploited by people opposed to vaccination. With a publicly searchable database, full of unverified reports of health problems that occurred sometime after vaccination, VAERS has proven irresistible to the anti-vaccination community, which often falsely claims the number of reported deaths or other issues is proof that vaccines are dangerous.

That’s despite the fact that the reports aren’t vetted for accuracy and don’t mean that a vaccine caused a particular problem.

VAERS is an early warning system used to identify potential safety concerns after a vaccine has been authorized or approved in the U.S. It’s often described as a “frontline” system, since it’s frequently the first vaccine safety system to detect a problem. But it’s also noisy and prone to distortion.

“Most of the anti-vaccine stuff that you hear, when they start to talk about how vaccines caused whatever, they’ll point to VAERS data,” Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, told us. “It is just manna from heaven to get bad information out there.”

While VAERS distortions were already a staple of vaccine misinformation prior to the pandemic, misuse of VAERS exploded with the arrival of the COVID-19 vaccines in late 2020. At FactCheck.org, we’ve written story after story debunking false or misleading claims about the COVID-19 vaccines that were based on misunderstandings about VAERS — and so have our fellow fact-checkers.

And now, one of the most notorious abusers of VAERS data is running for president. Robert F. Kennedy Jr., the nephew of assassinated President John F. Kennedy and a prominent anti-vaccine advocate, announced his campaign challenging President Joe Biden in April. (Kennedy has stated that he is for safer vaccines and is not “anti-vaccine,” but many of his arguments against vaccination are inaccurate or misleading and typical of the movement.)

In 2016, Kennedy founded a group that would become Children’s Health Defense, a nonprofit that traffics in anti-vaccine misinformation and disinformation. Hundreds of stories on Kennedy’s website mention VAERS.

Given the misuse and confusion around VAERS, a research team at the University of Pennsylvania’s Annenberg Public Policy Center — led by APPC Director Kathleen Hall Jamieson and in partnership with Critica Science — has proposed renaming VAERS “Vaccination Safety Monitor” or “Vaccination Safety Watch.” APPC is FactCheck.org’s parent organization.

Here, we’ll explain how VAERS works and run through five misconceptions that anti-vaccination activists wield to mislead people about vaccines.

A Frontline System, Ripe for Distortion

As we’ve explained before, vaccines given to the public have already been tested in clinical trials, but those trials can only be so big and aren’t expected to be able to identify rare side effects. That’s where VAERS and other post-marketing safety surveillance systems come in.

VAERS, which began in 1990 and is co-run by the Centers for Disease Control and Prevention and the Food and Drug Administration, collects reports of health problems that occur after vaccination. Anyone can submit a report, regardless of whether it’s likely the vaccine caused the event.

The CDC and FDA then review the reports in a variety of ways, and further investigate any possible safety concerns.

“VAERS is designed to detect unusual or unexpected patterns,” Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office, told us in an interview. “It’s really about pattern recognition.”

Key strengths of VAERS are its large size and speed. Because VAERS reports draw from across the country, even a very rare event can be quickly identified as a possible side effect. 

Most famously, VAERS was the first system to raise concerns about a link between intussusception, a type of intestinal blockage, and RotaShield, the first rotavirus vaccine. In June 1999, just nine months after approval, 10 reports of intussusception had been reported to VAERS in infants who had received the RotaShield vaccine. This triggered further study of the issue and led CDC to temporarily suspend the shot the following month. The manufacturer recalled the vaccine a few months later, after other studies confirmed the safety signal.

Susan S. Ellenberg, a biostatistician at the University of Pennsylvania’s Perelman School of Medicine, told us the RotaShield example is the “poster child” for how VAERS can work.

VAERS has successfully flagged other safety concerns, including inflammation of the heart and surrounding tissue, known as myocarditis and pericarditis, which are the primary serious side effects of the mRNA COVID-19 vaccines. The conditions are rare after vaccination and are most frequent in young males after a second dose.

The system is also used to monitor the safety of different vaccine lots and to identify risk factors for developing certain vaccine side effects. VAERS data, for example, contributed to the decision to advise people with a severe immunodeficiency to avoid the RotaTeq and Rotarix rotavirus vaccines.

VAERS is unique in having its data available for anyone to access. In the early years, people had to file Freedom of Information Act requests to access the data. But in 2001, in the spirit of transparency, the agency posted the data online for download, a CDC spokesperson told us. In 2006, the data became searchable in an online tool.

Many of the features of VAERS, however, also make it susceptible to bad actors.

“The minute it was created, you could have argued that this was going to be misused, or at least misunderstood, because you’re asking people to understand the difference between causality and coincidence,” Offit said.

Ellenberg, who oversaw VAERS at FDA between 1993 and 2004, told us the system’s data was misused “from the very beginning.” She recalled one effort by the National Vaccine Information Center, a prominent anti-vaccination group, to use VAERS data to claim that certain vaccine lots, or what it called “hot lots,” were dangerous.

“They would look at VAERS and find vaccine lots that had the most reports associated with them and put them out there as those were potentially more toxic,” she said. “What the truth is, is that vaccine lots are variable sizes” and it’s completely normal for a vaccine lot with 100,000 doses to have more VAERS reports than one with 3,000. Lot sizes are proprietary information and therefore are not publicly available.

As PolitiFact has reported, the National Vaccine Information Center created its own VAERS search tool in 2003 that has become a favorite of anti-vaccination activists, fueling VAERS-based misinformation.

Federal officials have attempted to explain the limitations of VAERS and to discourage misinterpretations of the data, both in disclaimers on the website and in multiple academic articles.

As early as 1997, Ellenberg explained in a journal article that the way VAERS is designed, “sensitivity takes precedence over specificity; reporting of all serious events following vaccination is encouraged, inevitably resulting in large numbers of reports that do not represent vaccine-induced problems.”

“VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance,” Shimabukuro and colleagues wrote in a 2015 article published in Vaccine, noting that VAERS is “primarily a safety signal detection and hypothesis generating system.”

“VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination,” they added.

Claims involving VAERS have nevertheless figured prominently in anti-vaccine efforts to reduce the reach of a variety of vaccines, including the measles, mumps and rubella, and human papillomavirus vaccines.

With the COVID-19 vaccines, Ellenberg said the problem became “substantially worse.” Offit agreed that claims have “dramatically increased.” And anti-vaccine activists are using the tactics honed during the pandemic to apply them once again to other vaccines.

Common Patterns of Deceptions

1) Inappropriately Assuming Causality (And Accuracy)

Perhaps the biggest misunderstanding about VAERS is that the health issues described in the reports are not necessarily caused by the vaccine — and are often purely coincidental.

“Reports in VAERS simply represent something that happened after you got a vaccine. They don’t tell you the vaccine caused this,” Ellenberg said.

In some cases, it may be reasonable to assume the vaccine was the cause, such as some swelling on an arm just after a shot. But usually, Shimabukuro said, the information provided in a report isn’t enough to know whether a health problem was caused by a vaccine.

“Vaccines protect against a particular thing, a particular disease. They don’t protect against everything bad that might ever happen to you,” Ellenberg said. And so it’s inevitable that bad things will occur by chance right after a vaccine, even when they have nothing to do with the vaccine. 

People are encouraged to file a report for any significant health problem even if they don’t think a vaccine was the cause. Health care workers and vaccine manufacturers are also required to file certain reports, also regardless of the level of suspicion of a vaccine.

And yet, the internet is littered with examples of people incorrectly presenting VAERS reports as events caused by vaccines. Sometimes the health problems are explicitly and inaccurately called side effects or labeled “vaccine-caused.” (Side effects, which are also known as adverse reactions, are considered to be caused by a shot.) Posts will also assume causality, for example, when citing VAERS data to give a supposed number of “COVID vaccine deaths.”

Some posts correctly note that VAERS reports may not have been caused by vaccines, but still mislead by calling the reports “vaccine injuries” or suggesting they are indicative of an important health concern.

Part of the issue, Offit said, is the terminology, including the name of the Vaccine Adverse Event Reporting System. In scientific parlance, the term “adverse event” does not imply a causal connection. It simply means the event occurred after vaccination, so there’s a temporal association that could very well be coincidental. To most of the public, though, that nuance is lost.

“Its mere name gives it the imprimatur of a causal association and that’s not what it is,” Offit said of VAERS. “It’s misnamed.”

On top of that, people often incorrectly assume that the reports must be true because they are in a government database.

But as the VAERS website explains in a disclaimer, reports “may contain information that is incomplete, inaccurate, coincidental, or unverifiable.” Reports are not vetted before being included in the database.

In a now classic example, Dr. James R. Laidler, an anesthesiologist and autism advocate, said he filed a report in VAERS in the early 2000s that claimed “an influenza vaccine had turned me into The Hulk.” The report went into the database and was removed only after someone from VAERS contacted him, and after a discussion, asked if it could be deleted.

“If I had not agreed, the record would be there still,” Laidler wrote in a 2005 blog post, “showing that any claim can become part of the database, no matter how outrageous or improbable.”

That’s not to say that most VAERS reports are made-up. As we’ve written, the number of obviously false hoax reports is below 1%, and it’s illegal to file a false claim. But it’s not always clear when a report is fraudulent, and research has shown that litigation — even related to health issues that scientists know are not caused by vaccines — can drive up reporting.

2) Misunderstanding or Ignoring How VAERS Works with Other Systems

People opposed to vaccines often focus on VAERS to the exclusion of other vaccine safety systems — ignoring the fact that some of those systems are used to determine whether a possible safety signal from VAERS is indeed a problem.

As Dr. David Gorski, an editor of the blog Science-Based Medicine who has been debunking claims about vaccines for more than a decade, observed on Twitter, the reason these activists “fetishize #VAERS as the ‘definitive’ be-all and end-all of vaccine safety databases is because it is so easily distorted and weaponized.”

“VAERS at its best is a hypothesis-generating system,” Offit said. It’s all about signal detection — it’s not meant to be the final word on vaccine safety. And it doesn’t work in a vacuum.

“It’s important for people to know that VAERS is one of many complementary systems that CDC and FDA and other federal partners use to monitor vaccine safety,” Shimabukuro said.

Statistical methods are used to analyze VAERS reports to quickly pick up on any unusual patterns. “If a possible safety signal is found in VAERS, further analysis is performed with other safety systems, such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA) Project, or in the FDA BEST (Biologics Effectiveness and Safety) system,” the VAERS disclaimer explains. “These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events.”

Indeed, while VAERS is a passive system, relying on people to submit reports, several of these systems are active, meaning they automatically collect information at regular intervals. And unlike VAERS, some of these systems offer a way of comparing outcomes to a control group. 

The Vaccine Safety Datalink, for example, draws on electronic health records from across the country and contains information about which vaccinations were given and when. The data are updated every week, and can be used to compare the rates of possible side effects in people who received a particular vaccine with a similar group of people who were not vaccinated.

The CDC and FDA use several quantitative methods to probe VAERS data for possible safety signals. This includes disproportionality analysis, which essentially checks to see whether the adverse events reported for one vaccine are significantly different from those reported for other vaccines, which could be indicative of a problem.

Ellenberg likens these approaches to looking for a needle in a haystack. “What these methods do is pull out clumps and then you look for needles in the clumps.” After further investigation, she said, most of them will turn out to be nothing.

Because the number of administered doses was known, regulators also performed an observed versus expected analysis for the COVID-19 vaccines, Shimabukuro said. If the observed rate approaches or exceeds the expected rate, he said, “that may be evidence of a potential safety problem that might require further investigation.”

Agency physicians also do a lot of case review to investigate possible problems.

Importantly, this slicing and dicing of VAERS data can only point to a possible issue — it’s not confirmation of one. 

“Just because you exceed a statistical threshold does not mean you have evidence of an increased risk or evidence of a causal association,” Shimabukuro said, adding that such data mining “findings” are not necessarily safety signals. “There can be other reasons for these findings or they can be spurious findings or in some cases, they can be things that we expect to find.”

VAERS, therefore, must be viewed in the larger context of how safety signals are identified. Insisting that only VAERS has the right answers is illogical and fundamentally misconstrues how vaccine safety surveillance works.

3) Improperly Comparing Vaccines

Much of the misinformation about the COVID-19 vaccines using VAERS has focused on improper comparisons between vaccines. Claim after claim alleges that because so many more VAERS reports have been filed for the COVID-19 vaccines than for other vaccines, it must mean that they are dangerous.

This line of argument, however, is faulty. As we’ve previously written, there are several reasons why reporting to VAERS increased for the COVID-19 vaccines — and it doesn’t mean that the vaccines aren’t safe. 

To start, a large number of COVID-19 vaccines were given out in a relatively short period of time, with more doses and priority given to older and more medically vulnerable people. The VAERS reporting requirements are also higher for the COVID-19 vaccines. Health care providers, for example, are required by law to report any vaccine administration error, any serious adverse event following vaccination, and any COVID-19 case that results in hospitalization or death. With other vaccines, providers are only required to report select adverse events. And the incredible amount of publicity and scrutiny of the new vaccines is arguably unprecedented in modern history.

“You really can’t compare what happened during COVID to what’s happened with other vaccines in the past,” Shimabukuro said.

The closest example, he said, is the rollout of an influenza vaccine during the H1N1 pandemic in 2009. With that vaccine, he added, there was also a large increase in the number of reports to VAERS, and public awareness “was nowhere near what it is for COVID-19.”

Shimabukuro noted that the phenomenon of a spike in reporting with a new vaccine, known as the Weber effect, is well documented.

And he added, the COVID-19 vaccines have been following the expected trajectory of the Weber effect quite closely, with very high reporting early on, followed by a peak and then a drop-off to a somewhat normalized level.

“The trend is very similar to what we see for other vaccines — other new vaccines, other pandemic vaccines,” Shimabukuro said, with the extreme attention on the COVID-19 pandemic “accentuating that overall trend.”

How are regulators so confident that the increased reporting in VAERS isn’t a safety concern? Because all of the data — including from VAERS, but also from all the other systems — consistently show that the COVID-19 vaccines have a good safety record.

“It’s data from multiple systems in the United States and data from other systems in other countries in Europe and in Canada and Israel, and really all over the globe,” Shimabukuro said.

Despite all the claims about COVID-19 vaccine-related deaths, VAERS data do not suggest that the vaccines increase mortality.

Of the COVID-19 vaccines ever offered in the U.S., only the Johnson & Johnson vaccine has been causally linked to thrombosis with thrombocytopenia syndrome, or TTS, which can be fatal. TTS is a blood clotting condition combined with low blood platelets and is extremely rare. Six reports of the condition to VAERS led regulators to temporarily suspend the use of the J&J vaccine in April 2021. Through May 2023, monitoring has identified nine deaths from TTS that are considered to be due to the vaccine. The J&J vaccine is no longer available in the U.S., after the last doses expired in May.

“There is no hiding in the world of vaccines when you vaccinate hundreds of thousands and then millions and tens of millions of people,” Offit said. If a vaccine is truly responsible for a serious side effect, he said, it will be apparent.

4) Exaggerating the Issue of Underreporting

Another common anti-vaccine talking point is that because people voluntarily report to VAERS, it invariably is an undercount of vaccine “harms.” Vaccine opponents often try to calculate how much underreporting exists and multiply the number of reports by certain factors to arrive at the “real” number of vaccine side effects. 

But this approach is flawed. It’s true that by design, VAERS can’t capture every side effect that is due to a vaccine. But it’s also the case that many of the health problems in VAERS aren’t caused by a vaccine.

“There’s underreporting and there’s overreporting,” Ellenberg said, referring to both scenarios. 

“The suspected adverse events are underreported. I think that’s probably true. But the keyword there is suspected — they’re not necessarily true, truly caused by vaccines,” Offit said, adding that that’s expected with a passive system. That’s precisely why other, active vaccine safety systems are also used to monitor vaccines. 

And there’s no simple way of determining how much underreporting exists. Anti-vaccine groups commonly cite a 2010 report from Harvard Pilgrim Health Care that stated “fewer than 1% of vaccine adverse events are reported.” 

But Dr. Michael Klompas, a public health surveillance researcher at Harvard Medical School and one of the authors of the report, told us in an email that the 1% number “takes into account that many adverse effects of vaccines are mild and expected so not worth reporting (sore arm, fatigue, local redness, etc.).”

Other researchers have attempted to estimate what’s called the reporting efficiency, or reporting sensitivity, of certain adverse events in VAERS, generally finding that the system more completely collects serious adverse events than mild ones.

An early effort in 1995, for example, found that VAERS detected 68% of vaccine-associated polio cases following the oral polio vaccine, but less than 1% of rashes after the MMR vaccine. (The oral polio vaccine has since been replaced in the U.S. with an injected vaccine that cannot give people the disease.)

Other work has found that for anaphylaxis, a potentially life-threatening allergic reaction that occurs rarely with any vaccine, VAERS captured anywhere from 13% to 76% of cases, depending on the vaccine. Another study estimated that VAERS caught 47% of cases of intussusception after the RotaShield vaccine. 

But as that paper noted, “Although the reporting completeness of VAERS has been evaluated for some specific vaccine-event associations, this information cannot be generalized.”

“The magnitude of underreporting varies widely, depending upon factors such as the severity of the event, proximity in time of the event to vaccination, and preexisting awareness on the possible association of the event to the vaccine,” it reads.

While underreporting is a legitimate limitation of VAERS, the system is not intended to capture everything. And applying ad hoc estimates for underreporting, particularly to all adverse events, or for adverse events that have not been linked to vaccination, is scientifically unsound and misleading.

5) Incorrectly Assuming All Reports Are Serious

Finally, another misconception is the incorrect notion that all reports in VAERS are serious. Again, part of this hinges on the use of technical language. “Adverse event” sounds serious to many people, but it includes minor incidents, such as a sore arm. 

Less than 10% to 15% of U.S. reports in VAERS are considered “serious” — a regulatory term that means the event was life-threatening or involved hospitalization, prolonged hospitalization if someone was already hospitalized, persistent disability, a birth defect, death, or required medical attention to prevent one of these outcomes.

The CDC requests follow-up information for all serious reports, which, like their non-serious counterparts, may be entirely coincidental. As the CDC explains, while serious events happen after vaccination, “they are rarely caused by the vaccine.”

The non-serious and serious classification isn’t perfect. “Some degree of misclassification is inherent,” a 2004 review by government scientists explains, noting that injection site reactions typically are “not of great clinical significance but may be classified as serious if they result in a brief hospitalization.” On the other hand, something like Bell’s palsy, a usually temporary facial paralysis, is medically important, but may not be classified as serious because it involves outpatient care.

Still, it’s clear that many of the health issues reported to VAERS — which again, are not necessarily caused by vaccines — are relatively minor, and people who like to highlight the sheer number of reports to suggest vaccines are dangerous are not being fully transparent.

Imperfect, But Still Necessary

For all of its limitations and susceptibility to distortion, experts generally told us they thought VAERS served an important role.

Ellenberg, for example, said she thought VAERS could be the fastest way to identify a vaccine safety problem. 

Offit, however, was less sure of its utility.

“I would argue that because it’s so massively misused and massively misunderstood,” which has caused “a lot of people to choose not to get a vaccine,” he said, “I think it has done far more harm than good.”

Still, he doesn’t think VAERS should go away. Rather, he thinks VAERS should not be made publicly available. That would limit the misinformation, but still allow the system to do its job.

Putting the genie back in the bottle, though, may be impossible. And for now, the CDC doesn’t agree.

“We understand that there is the potential for misuse and misrepresentation of VAERS data,” Shimabukuro said. “However, we think the benefits of being transparent and providing these data as a public service outweigh the potential harms.”

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 What VAERS Can and Can’t Do, and How Anti-Vaccination Groups Habitually Misuse Its Data appeared first on FactCheck.org.

SciCheck Digest

Ventilators can be lifesaving for critically ill COVID-19 patients. A social media claim that a new study shows ventilators killed “nearly all” COVID-19 patients is “quite wrong,” according to the study’s co-author. Ventilator-associated complications can contribute to deaths, but patients are typically put on ventilators when they would otherwise die.

Full Story

COVID-19 can cause lung damage and respiratory failure. In patients who are unable to breathe well enough to supply oxygen to their bodies, mechanical ventilators can be lifesaving and give them time to recover. Ventilators help people breathe by pushing air into their lungs via a tube inserted down their windpipe.

Yet, social media posts have shared an article from the People’s Voice with a false headline: “Official Report: Ventilators Killed Nearly ALL COVID Patients.” The People’s Voice, formerly News Punch, frequently publishes articles with false and inflammatory headlines.

The posts misrepresent the conclusions of a study published in April in the Journal of Clinical Investigation. The idea that ventilators — and not COVID-19 — killed nearly all COVID-19 patients is “quite wrong,” study co-author Dr. Benjamin Singer, a pulmonary and critical care physician at Northwestern Medicine, told us.

Rep. Thomas Massie, a Republican from Kentucky, also misrepresented the conclusions of the study, tweeting, “How many COVID patients died due to the use of ventilators? A recent examination of the data suggests quite a few.”

The idea that ventilators are dangerous, and not COVID-19, is a misinterpretation of his data, Singer said. “It’s not the ventilator that was the cause of death,” he said. “The ventilator was very much life support for these patients. It was ultimately COVID-19” that caused the deaths.

Singer’s study looked at 585 people put on ventilators due to respiratory failure between 2018 and 2022 at Northwestern Memorial Hospital. These people primarily had COVID-19 or some other infectious disease, such as another viral or bacterial illness.

Around half of these very sick patients who required mechanical ventilation — people who likely would have died without the intervention — went on to survive their illness. The survival rate was similar whether they had COVID-19 or another disease and was consistent with the survival rate for COVID-19 patients on ventilators found in another, larger study.

Singer’s study explored the degree to which a known ventilator-related complication called ventilator-associated pneumonia contributes to death, finding that the complication is more common in people with COVID-19 and, when unresolved, is linked to death. VAP is usually treated with antibiotics.

People with COVID-19 likely have an elevated risk of VAP because they stay on ventilators for longer-than-average periods. COVID-19 also affects the immune system and damages the surface of the lungs in unique ways, Singer said, which could potentially make the lungs more susceptible to secondary infections.

VAP contributes to death in some COVID-19 and other infectious disease patients, explained Dr. Mark Metersky, a pulmonary and critical care physician and professor at the University of Connecticut School of Medicine who was not involved in the study.

However, virtually all of these patients would have died if they had not been put on a ventilator, he said. “It’s not that the ventilator killed them, the ones who died. It’s that the ventilator failed to save them.”

A related claim in a popular post — that medical professionals put patients on ventilators due to financial incentives — is also unsupported by evidence, as we and other fact-checkers previously explained. It’s standard for hospitals to get more money for patients, such as those on ventilators, who require more care.

Study Explored Ventilator-Related Pneumonia

VAP typically occurs as a form of secondary pneumonia, which means it shows up in patients who already have another pneumonia diagnosis, such as pneumonia resulting from COVID-19, the flu or a bacterial infection.

People are diagnosed with pneumonia when their lungs become swollen with fluid from a respiratory infection. VAP typically arises from bacteria introduced to the lungs via the patient’s breathing tube.

Singer’s new paper finds that once very sick COVID-19 patients are on ventilators, they are at greater risk of VAP compared with other similarly ill pneumonia patients, he said.

Further, the paper found that “whether that ventilator-associated pneumonia was cured or not was a major determinant of whether patients went on to live or die in the ICU,” he said. However, just being diagnosed with VAP was not associated with a higher risk of death.

Based on these conclusions, the People’s Voice article makes a false claim, which was shared widely: “Nearly all COVID-19 patients who died in hospital during the early phase of the pandemic were killed as a direct result of being put on a ventilator, a disturbing new report has concluded.”

First, many hospitalized COVID-19 patients have died who never went on ventilators. And Singer’s study was not limited to “the early phase of the pandemic” but rather went through March 2022.

As we’ve said, this line of thinking is also misleading because it does not make it clear that the patients on ventilators would have typically died without them. It is also untrue that Singer’s study showed that ventilator-related complications killed “nearly all” ventilated patients who died.

The People’s Voice article explains its reasoning by saying that “most patients” put on ventilators because of COVID-19 developed VAP. “So while COVID-19 may have put these patients in the hospital, it was actually a secondary infection brought on by the use of a mechanical ventilator that caused their deaths,” the article says.

In reality, 57% of COVID-19 patients on ventilators in the study developed VAP and a quarter of other ventilated pneumonia patients did. Around half of all patients with VAP died, which was “not significantly different” from the death rate in patients on ventilators who didn’t have VAP, according to the study.

Singer and his colleagues did find that patients whose VAP was not successfully treated were more likely to die than patients whose VAP resolved, indicating a connection between VAP and poor outcomes. The study was not randomized, and the researchers write that they cannot definitively determine that unresolved VAP — and not some other factor associated with it — leads to poor outcomes.

Metersky was skeptical that VAP is that much of a contributor to mortality, pointing to other studies that show a lower rate of VAP in pneumonia patients than was found in Singer’s study.

“Yes, some patients who are put on a ventilator will develop a fatal complication,” Metersky said. “Probably 1 in 100” patients put on a ventilator develop fatal VAP, he said, based on data from before the pandemic. Since about twice as many COVID-19 patients develop VAP compared with other pneumonia patients on ventilators, he said that would indicate that around 2% of people with COVID-19 who go on a ventilator die of VAP.

“But there are other complications,” Metersky said. These can include damage to the lungs from high oxygen and the air pressure from the ventilator or side effects from drugs used to sedate people on ventilators, for instance. “That’s why we don’t put a patient on a ventilator unless they absolutely need it,” he said.

Regardless, “it’s ridiculous to go from that study to say that the ventilators are killing all these people,” Metersky said, referring to the claim that nearly all COVID-19 deaths were caused by ventilators.

Early Ventilation Did Not Cause Mass Deaths

Other false claims, reviewed previously by others, state that overuse of ventilators played a major role in the first wave of COVID-19 deaths.

There were some suggestions very early in the pandemic that doctors should put COVID-19 patients on ventilators earlier than other pneumonia patients, Singer and Metersky both said, out of concern that respiratory failure might progress very quickly. 

This was soon followed by calls for caution in ventilating patients early, and these practices quickly stopped, Singer said. “The standard indications for initiation of mechanical ventilation are really the same as they always have been” for patients with pneumonia, he said, regardless of whether they have COVID-19.

Multiple facts about the early ventilation recommendations are unclear. First, there was no standard definition of what experts meant when recommending “early” ventilation. Decisions on when patients require mechanical ventilation are based on the best judgment of their doctors as they monitor multiple indicators. Doctors want to be sure the ventilator is truly necessary — that the patient is headed toward death from respiratory failure without it. But they also don’t want to wait until the patient has organ damage from lack of oxygen.

Second, it’s unclear how widespread early ventilation was. Singer mentioned that his own recent paper showed that Northwestern Medicine put patients with COVID-19 on ventilators after a similar amount of time in the ICU as other pneumonia patients. Others have pointed out that some doctors at the beginning of the pandemic took measures to avoid putting patients on ventilators due to shortages.

Finally, it’s uncertain what impact early ventilation had on patients. The available research, recently reviewed in a blog post by epidemiologist Gideon Meyerowitz-Katz, a Ph.D. candidate at the University of Wollongong in Australia, indicates that early versus later ventilation did not appreciably affect COVID-19 deaths. For instance, a review study that pooled and analyzed data from multiple studies found that going on a ventilator within a day of entering the ICU versus later had no impact on mortality.

It is possible that people occasionally were put on ventilators who could have avoided them, but this is difficult to quantify.

“There were probably a small number of patients who got put on a ventilator who ultimately might not have needed it,” Metersky said. “As we learned more about the disease, we learned to recognize that some patients may not need the ventilator. But it wasn’t this big conspiracy that we put everyone on the ventilator even though they could have gone home instead.”

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.

Sources

“Pulmonary Manifestations.” COVID-19 Real-Time Learning Network. Updated 22 Feb 2022.

Tobin, Martin and Manthous, Constantine. “Mechanical Ventilation.” American Journal of Respiratory and Critical Care Medicine. Published 15 Jul 2017. Updated April 2020.

Adl-Tabatabai, Sean. “Official Report: Ventilators Killed Nearly ALL COVID Patients.” The People’s Voice. 13 May 2023.

Jones, Brea. “Posts Fabricate Charge Against Bill Gates in Philippines.” FactCheck.org. 10 Mar 2023.

Spencer, Saranac Hale. “Hate Crimes Hotline Headline Is Wrong.” FactCheck.org. 30 Nov 2018.

Yandell, Kate. “Posts Share Fake Chelsea Clinton Quote About Global Childhood Vaccination Effort.” FactCheck.org. 10 May 2023.

Gao, Catherine A. et al. “Machine Learning Links Unresolving Secondary Pneumonia to Mortality in Patients with Severe Pneumonia, Including COVID-19.” The Journal of Clinical Investigation. 27 Apr 2023.

Massie, Thomas (@RepThomasMassie). “How many COVID patients died due to the use of ventilators? A recent examination of the data suggests quite a few. ‘The investigators found nearly half of patients with COVID-19 develop a secondary ventilator-associated bacterial pneumonia.’” Twitter. 15 May 2023.

Nolan, Margaret B. et al. “Mortality Rates by Age Group and Intubation Status in Hospitalized Adult Patients From 21 United States Hospital Systems During Three Surges of the COVID-19 Pandemic.” Chest. 29 Jan 2023.

“Frequently Asked Questions about Ventilator-Associated Pneumonia.” CDC website. Updated 9 May 2019.

Adele – Conspiracy Queen 👑 (@truth.bomb.mom). “Such a bummer that this happened 😢.” Instagram. 21 May 2023.

Fichera, Angelo. “Hospital Payments and the COVID-19 Death Count.” FactCheck.org. 21 Apr 2020.

Kertscher, Tom. “Fact-Check: Hospitals and COVID-19 Payments.” PolitiFact. 21 Apr 2020.

“Pneumonia – Causes and Risk Factors.” NIH website. Updated 24 March 2022.

“Pneumonia – What Is Pneumonia?” NIH website. Updated 24 Mar 2022.

Kohbodi, GoleNaz A. et al. “Ventilator-Associated Pneumonia.” Updated 10 Sep 2022.

Metersky, Mark L. et al. “Trend in Ventilator-Associated Pneumonia Rates Between 2005 and 2013.” JAMA. 13 Dec 2016.

Melsen, Wilhelmina G., et al. “Attributable Mortality of Ventilator-Associated Pneumonia: A Meta-Analysis of Individual Patient Data from Randomised Prevention Studies.” Lancet Infectious Diseases. 25 Apr 2013.

Metersky, Mark L. et al. “Temporal Trends in Postoperative and Ventilator-Associated Pneumonia in the United States.” Infection Control and Hospital Epidemiology. 3 Nov 2022.

Meyerowitz-Katz, Gideon. “Did Ventilators Kill People During COVID-19?” Medium. 25 May 2023.

Howard, Jonathan. “Intubations and Accusations: Doctors Were ‘Just Going Crazy, and Intubating People Who Did Not Have to Be Intubated.'” Science-Based Medicine. 19 Sep 2021.

Tobin, Martin J. et al. “Caution about Early Intubation and Mechanical Ventilation in COVID-19.” Annals of Intensive Care. 9 Jun 2020.

Anesi, George L. “COVID-19: Respiratory care of the nonintubated hypoxemic adult (supplemental oxygen, noninvasive ventilation, and intubation).” UpToDate. Updated 22 May 2023.

Marino, Ryan (@RyanMarino). “And -anecdotally- I was treating COVID patients in 2020. It was bleak and terrifying. They were incredibly sick and we actually did not have enough ventilators as we needed for this disease. I still remember the panicky feeling of using every possible attempt to avoid intubation.” Twitter. 15 May 2023.

Mansfield, Erin. “As the Coronavirus Curve Flattened, Even Hard-Hit New York Had Enough Ventilators.” USA Today. 28 Apr 2020.

Papoutsi, Eleni et al. “Effect of Timing of Intubation on Clinical Outcomes of Critically Ill Patients with COVID-19: A Systematic Review and Meta-Analysis of Non-Randomized Cohort Studies.” Critical Care. 25 Mar 2021.

The post Ventilators Save Lives, Did Not Cause ‘Nearly All’ COVID-19 Deaths appeared first on FactCheck.org.

SciCheck Digest

The rate of new HIV infections in the military has been relatively unchanged since 2017. But social media posts falsely claim that the military has recorded a “500% increase in HIV since the COVID vaccine rollout.” A Defense Department spokesperson said errors in a military database sparked the inaccurate claim.

Full Story

COVID-19 vaccines were introduced to the general public in December 2020. About 81% of the U.S. population have received at least one dose of a vaccine as of May 10, according to the Centers for Disease Control and Prevention. 

In August 2021, Secretary of Defense Lloyd Austin III mandated that members of the armed forces receive the vaccine. By December 2021, 96% of active-duty military members were fully vaccinated. An individual must follow mandates and pass the fitness standard in order to stay in or be allowed to join the armed forces. The vaccine mandate for members of the military was rescinded on Jan. 10.

In recent weeks, posts on social media have wrongly claimed that the military recorded a 500% increase in new HIV infections since the COVID-19 vaccines were introduced.

“DOD database reports 500% increase in HIV since the COVID vaccine rollout,” reads part of an Instagram post.

But there is “no association between COVID-19 vaccines and risk for HIV infection,” according to the CDC.

HIV, or human immunodeficiency virus, attacks the body’s immune system, and if left untreated can lead to acquired immunodeficiency syndrome, or AIDS.

The false claim on social media was based on incorrect data in a military medical system.

A spokesperson for the Defense Department told us in an email, “This is a false claim stemming from a rumor about the Defense Medical Epidemiology Database,” a tool used to access data on active service members within the Defense Medical Surveillance System, or DMSS.

“The Defense Health Agency’s Armed Forces Health Surveillance Division (AFSHD) conducted a complete review of the data contained in the Defense Medical Epidemiology Database (DMED) and found that the data was incorrect for the years 2016-2020,” the spokesperson said. (Emphasis is the Defense Department’s.) 

“Comparing the DMED database to the source data contained in DMSS, AFHSD discovered that the total number of medical diagnoses from 2016-2020 that were accessible in DMED represented only a small fraction of actual medical diagnoses for those years. In contrast, the 2021 total number of medical diagnoses were up to date in DMED. Comparison of 2021 to 2016-2020 resulted in the appearance of significant increased occurrence of all medical diagnoses in 2021 because of the under reported data for 2016-2020.”

“AFHSD has corrected the root-cause of the data corruption and it has been restored to full functionality,” the spokesperson said.

HIV is one of 434 medical conditions that can cause an individual to be disqualified from joining the military. “While DOD policy prohibits the accession of any applicant who tests positive for HIV, current service members who become infected may continue to serve,” according to a March report by the Congressional Research Service.

From January 2017 to June 2022, 1,581 service members were diagnosed with HIV, according to “HIV/AIDS in the Military,” a report published in March by the Congressional Research Service.

“As of 2022, 981 (62%) remain in military service,” the Defense Department spokesperson said. 

The amount of new HIV cases has fluctuated in recent years. There were 280 in 2018, 314 in 2019, 237 in 2020, 309 in 2021, and 124 in 2022, according to data provided by the spokesperson.

The largest annual increase was 30.4% in 2021 and the largest decrease was 60% in 2022 – nothing as large as the 500% increase cited in the social media posts.

The CRS report also notes, “The rate of newly diagnosed HIV infections (also called the seroprevalence rate) among service members tested in 2021 was 23 per 100,000.” That was the same rate as in 2017 — before COVID-19 vaccines were introduced. 

This isn’t the first time that the military database has been the source of false social media claims.

Reuters Fact Check last year debunked social media posts that listed HIV and numerous other “medical conditions that purportedly ‘skyrocketed’ among U.S. military personnel in 2021.” But those increases were all due to the same error in the Defense Medical Epidemiology Database for the years 2016 through 2020.

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.

Sources

“Almost All Active Duty Service Members Receive Vaccines.” Department of Defense. 16 Dec 2021. 

“COVID-19 Vaccinations in the United States.” Centers for Disease Control and Prevention. 11 May 2023.

“DOD Rescinds COVID-19 Vaccination Mandate.” Department of Defense. 10 Jan 2023. 

“Defense Medical Epidemiology Database.” Health.mil. Accessed 30 May 2023.

“Fact Check-DoD says data error caused spike in numbers of medical diagnoses in their medical database for 2021.” Reuters. 23 Feb 2023.

“HIV/AIDS in the Military.” Congressional Research Service. 31 May 2019.

“HIV/AIDS in the Military.” Congressional Research Service. 21 March 2023.

 McDonald, Jessica. “Q&A on COVID-19 Vaccines.” FactCheck.org. Updated 26 Sept 2022. 

Spokesperson, Department of Defense. Email to Factcheck.org. 31 May 2023.

The post Database Errors Fuel False Claims about HIV Cases in Military appeared first on FactCheck.org.

SciCheck Digest

Numerous studies have shown the mRNA COVID-19 vaccines are safe and effective in preventing severe disease and death from COVID-19. But some social media posts are citing a criticized study that focuses on overall mortality to falsely imply the vaccines are harmful and don’t work. 

How effective are the vaccines?

Full Story

Both mRNA COVID-19 vaccines, from Moderna and Pfizer/BioNTech, showed excellent results in the clinical trials. There were no serious safety concerns reported for either of them, and both were more than 90% effective in preventing symptomatic and severe COVID-19.

With the arrival of new viral variants and the passage of time, the vaccines no longer provide strong protection against mild disease, but many studies have shown that these vaccines work very well in preventing severe COVID-19 and death. One estimate suggests that COVID-19 vaccines prevented more than 3 million deaths in the U.S. 

Johnson & Johnson’s COVID-19 vaccine, which is designed differently and uses a harmless adenovirus to trigger an immune response, showed a slightly lower efficacy. Although no serious safety issues were detected in the clinical trials, rare cases of a dangerous blood clotting condition combined with low blood platelets known as thrombosis with thrombocytopenia syndrome were reported in the U.S. shortly after the vaccine was authorized for use. In 2022, the FDA limited its authorization. Now that the last doses expired in May, the vaccine is no longer available in the country. 

But some social media posts are citing a recent study that reanalyzed data from the original trials to compare the impact of both types of vaccines — the mRNA and adenovirus vector COVID-19 vaccines — on deaths from all causes, to incorrectly imply that the mRNA vaccines are dangerous or have no effect on mortality from COVID-19.

“Researchers inadvertently reveal mRNA covid vaccines are NOT ASSOCIATED WITH LOWER MORTALITY in reassessment of Random Control Trials (RCTs),” reads a post on Instagram, which also misleadingly implies that the original trial data were interpreted incorrectly. “27 of the 31 deaths in the RCTs that took either Moderna or Pfizer were blood, heart, or artery related, to the shock of no one who’s been paying attention,” the post adds.

“COVID Shots Had ZERO Impact on Reducing Deaths, Study Finds,” reads the headline of an item on a conservative website.

The posts do not specify overall mortality, leading many viewers to incorrectly assume the vaccines don’t protect against death from COVID-19.

Cases of inflammation of the heart muscle or its surrounding tissue, known as myocarditis and pericarditis, have occurred after mRNA COVID-19 vaccination, mostly in young men and after a second dose. But cases are rare and patients usually respond well to medicine and recover quickly.

The Moderna and Pfizer/BioNTech mRNA COVID-19 vaccines have not been linked to any other heart problems. Nor have they been shown to increase the risk of death. Study after study has confirmed the benefits outweigh the small risks.

The cited study was published in April in the journal iScience by researchers from Denmark, the Netherlands, and Germany. The authors reanalyzed mortality data reported in the various clinical trials and found that the adenoviral vaccines appeared to reduce death from any cause, while the mRNA vaccines did not. They concluded that the adenoviral vaccines might have some beneficial effects.

Scientists have questioned the study since it was posted a year ago as a preprint. At that time, the study was also misinterpreted and used to misleadingly claim mRNA vaccines offer “no mortality benefit” at all, as our colleagues from PolitiFact wrote. 

The authors have acknowledged the limitations of the study and responded to some critics, but have not explicitly corrected claims stating the vaccines are dangerous or don’t reduce COVID-19 mortality. 

“It is not possible to say, based on our findings, that ‘mRNA COVID-19 vaccines are not effective or harmful,’” Dr. Christine Stabell Benn, the lead author, told us in an email. 

But Benn, who is a member of a controversial committee gathered by Florida Gov. Ron DeSantis to advise the state on public health issues, also told us the results from the clinical trials “do not exclude” the possibility that the vaccines “are associated with considerable harm.” As we’ve reported, DeSantis’ committee of contrarian experts held a roundtable in December claiming the COVID-19 vaccines were too risky.

The iScience Study

The iScience study’s goal was to determine if the COVID-19 vaccines had broad effects on the immune system, beyond the vaccine’s ability to prepare the immune system to better fight off the coronavirus. In particular, the authors wanted to use the available trial data to see if the vaccines had an effect on overall mortality.

Two of the authors of the study, Benn and Peter Aaby, both professors at the University of Southern Denmark, have been studying what are called non-specific effects of vaccines, or secondary vaccine effects, for decades.

Typically, vaccines targeting a particular disease are not expected to have any effects on other diseases, since the immune system is responding to specific pathogen. But some epidemiology studies suggest that some vaccines may have broader effects. The concept is still understudied and many questions remain, according to a report of a workshop on the topic held by the National Institute of Allergy and Infectious Diseases in July 2021.

To study the COVID-19 vaccines’ effects on overall mortality, the researchers counted the deaths reported in the two main mRNA trials and in five trials of three different adenovirus vector vaccines. They then combined the data for each vaccine type and compared it. 

For the mRNA vaccines, there were a total of 74,193 participants in both the Pfizer/BioNTech and the Moderna trials. Among them, there were 61 deaths: 31 in the vaccine groups and 30 in the placebo groups. Half of the non-COVID-19 deaths (27 of 54) were related to cardiovascular issues, the study found, and the vaccines had no beneficial effect on those deaths, according to the researchers. 

“There were no obvious benefits for these vaccines beyond preventing COVID mortality, which is not surprising,” said Dr. Peter J. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, after reviewing the study for us. “And we know, for instance, that after vaccines became widely available in the United States, the benefits of mRNA vaccines in terms of preventing mortality from COVID-19 were overwhelming.”

In the adenovirus vector vaccines trials included in the study, there were a total of 122,164 participants, with 46 deaths among them: 16 in the vaccine groups, 30 in the placebo groups. Therefore, the researchers concluded, the data suggested these vaccines were associated with a reduction in overall mortality, which they attributed to a lower COVID-19 mortality and a lower cardiovascular mortality (there were no cardiovascular deaths in the vaccine groups and eight in the placebo ones). 

“The results suggest that adenovirus-vector vaccines compared with placebo have beneficial non-specific effects, reducing the risk of non-COVID-19 diseases. The most important cause of non-COVID-19 death was cardiovascular disease, against which the data for the current RCTs suggest that the adenovirus-vector vaccines provide at least some protection,” researchers said.

The authors speculate that the adenovirus vector vaccines “prime the immune system in a way similar to a ‘live’ vaccine,” which is the kind of vaccine that uses weakened virus and has most often been found in their previous studies to have non-specific effects.

But to other scientists, these results are being overinterpreted. The data does not allow for a meaningful analysis, they say, since the vaccine trials were not designed to assess mortality and the available data is minimal.  

“It’s hard to say anything very conclusive,” Hotez, who participated in the NIAID workshop on secondary vaccine effects, told us about the paper. If anything, he said, it can generate a hypothesis that would need much broader testing and research.

“The claims about mRNA vaccines, including the purported cardiovascular effects, are based on far too few events to make any realistic conclusions,” Gideon Meyerowitz-Katz, an epidemiologist from the University of Wollongong in Australia, told us in an email.

“Moreover, we have an enormous wealth of more recent evidence demonstrating that mRNA vaccines save lives. This particular analysis takes a handful of deaths from very different populations – the mRNA vaccine trials were conducted in a very different patient population to the adenovirus vector vaccine trials – and inappropriately compares them.” 

He also said it was concerning that the study used trial data for the Sputnik vaccine, a Russian adenovirus COVID-19 vaccine. Meyerowitz-Katz and others have found data inconsistencies with that trial, raising questions about how trustworthy it is.

Dr. David R. Boulware, a professor of medicine at the University of Minnesota Medical School, told us the fact that the trials were held in different locations is very significant.

“[T]he adenovirus vaccine trials … were run mostly in low and middle income countries where the overall case fatality rate was 2%. The mortality in the mRNA vaccine trials, mostly run in high-income countries, was 0.3%. Deaths were too few to show any reduction,” he told us in an email. 

Benn and her team responded to these concerns in May 2022 after the preprint was published, and again in May 2023. They say the study results should not be dismissed because of the limited data.

“Our key message is that yes, data is regrettably limited, but it does show differences in mortality effect between the two major vaccine types that if true would have major global health implications,” Benn wrote on Twitter.

Regardless of whether the adenoviral vaccines have beneficial non-specific effects, it’s incorrect to suggest that the mRNA vaccines don’t protect against COVID-19 mortality, or to imply that they’re dangerous.

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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McDonald, Jessica. “A Guide to Moderna’s COVID-19 Vaccine.” FactCheck.org. Updated 21 Apr 2023. 

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McConeghy, Kevin W., et al. “Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents — 19 States, March 29–July 25, 2022.” MMWR. 30 Sep 2022

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Tenforde, Mark W., et al. “Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022.’ MMWR. 25 Mar 2022. 

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The post mRNA Vaccines Protect Against COVID-19 Mortality, Contrary to Misleading Posts appeared first on FactCheck.org.

SciCheck Digest

Families seeking information from a health care provider about a young child’s gender identity may have their questions answered or receive counseling. Some posts share a misleading claim that toddlers are being “transitioned.” To be clear, prepubescent children are not offered transition surgery or drugs.

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Some children identify with a gender that does not match their sex assigned at birth. These children are referred to as transgender, gender-diverse or gender-expansive. Doctors will listen to children and their family members, offer information, and in some cases connect them with mental health care, if needed.

But for children who have not yet started puberty, there are no recommended drugs, surgeries or other gender-transition treatments.

Recent social media posts shared the misleading claim that medical institutions in North Carolina are “transitioning toddlers,” which they called an “experimental treatment.” The posts referenced a blog post published by the Education First Alliance, a conservative nonprofit in North Carolina that says many schools are engaging in “ideological indoctrination” of children and need to be reformed.

The group has advocated the passage of a North Carolina bill to restrict medical gender-transition treatment before age 18. There are now 18 states that have taken action to restrict medical transition treatments for minors.

A widely shared article from the Epoch Times citing the blog post bore the false headline: “‘Transgender’ Toddlers as Young as 2 Undergoing Mutilation/Sterilization by NC Medical System, Journalist Alleges.” The Epoch Times has a history of publishing misleading or false claims. The article on transgender toddlers then disappeared from the website, and the Epoch Times published a new article clarifying that young children are not receiving hormone blockers, cross-sex hormones or surgery. 

Representatives from all three North Carolina institutions referenced in the social media posts told us via emailed statements that they do not offer surgeries or other transition treatments to toddlers.

East Carolina University, May 5: ECU Health does not offer gender affirming surgery to minors nor does the health system offer gender affirming transition care to toddlers.

ECU Health elaborated that it does not offer puberty blockers and only offers hormone therapy after puberty “in limited cases,” as recommended in national guidelines and with parental or guardian consent. It also said that it offers interdisciplinary gender-affirming primary care for LGBTQ+ patients, including access to services such as mental health care, nutrition and social work.

“These primary care services are available to any LGBTQ+ patient who needs care. ECU Health does not provide gender-related care to patients 2 to 4 years old or any toddler period,” ECU said.

University of North Carolina, May 12: To be clear: UNC Health does not offer any gender-transitioning care for toddlers. We do not perform any gender care surgical procedures or medical interventions on toddlers. Also, we are not conducting any gender care research or clinical trials involving children.

If a toddler’s parent(s) has concerns or questions about their child’s gender, a primary care provider would certainly listen to them, but would never recommend gender treatment for a toddler. Gender surgery can be performed on anyone 18 years old or older.

Duke Health, May 12: Duke Health has provided high-quality, compassionate, and evidence-based gender care to both adolescents and adults for many years. Care decisions are made by patients, families and their providers and are both age-appropriate and adherent to national and international guidelines. Under these professional guidelines and in accordance with accepted medical standards, hormone therapies are explicitly not provided to children prior to puberty and gender-affirming surgeries are, except in exceedingly rare circumstances, only performed after age 18.

Duke and UNC both called the claims that they offer gender-transition care to toddlers false, and ECU referred to the “intentional spreading of dangerous misinformation online.”

Nor do other medical institutions offer gender-affirming drug treatment or surgery to toddlers, clinical psychologist Christy Olezeski, director of the Yale Pediatric Gender Program, told us, although some may offer support to families of young children or connect them with mental health care. 

The Education First Alliance post also states that a doctor “can see a 2-year-old girl play with a toy truck, and then begin treatment for gender dysphoria.” But simply playing with a certain toy would not meet the criteria for a diagnosis of gender dysphoria, according to the medical diagnostic manual used by health professionals.

“With all kids, we want them to feel comfortable and confident in who they are. We want them to feel comfortable and confident in how they like to express themselves. We want them to be safe,” Olezeski said. “So all of these tenets are taken into consideration when providing care for children. There is no medical care that happens prior to puberty.”

Medical Transition Starts During Adolescence or Later 

The Education First Alliance blog post does not clearly state what it means when it says North Carolina institutions are “transitioning toddlers.” It refers to treatment and hormone therapy without clarifying the age at which it is offered. 

Only in the final section of the piece does it include a quote from a doctor correctly stating that children are not offered surgery or drugs before puberty.

To spell out the reality of the situation: The North Carolina institutions are not providing surgeries or hormone therapy to prepubescent children, nor is this standard practice in any part of the country.

Programs and physicians will have different policies, but widely referenced guidance from the World Professional Association for Transgender Health and the Endocrine Society lays out recommended care at different ages. 

Drugs that suppress puberty are the first medical treatment that may be offered to a transgender minor, the guidelines say. Children may be offered drugs to suppress puberty beginning when breast buds appear or testicles increase to a certain volume, typically happening between ages 8 to 13 or 9 to 14, respectively.

Generally, someone may start gender-affirming hormone therapy in early adolescence or later, the American Academy for Pediatrics explains. The Endocrine Society says that adolescents typically have the mental capacity to participate in making an informed decision about gender-affirming hormone therapy by age 16.

Older adolescents who want flat chests may sometimes be able to get surgery to remove their breasts, also known as top surgery, Olezeski said. They sometimes desire to do this before college. Guidelines do not offer a specific age during adolescence when this type of surgery may be appropriate. Instead, they explain how a care team can assess adolescents on a case-by-case basis.

A previous version of the WPATH guidelines did not recommend genital surgery until adulthood, but the most recent version, published in September 2022, is less specific about an age limit. Rather, it explains various criteria to determine whether someone who desires surgery should be offered it, including a person’s emotional and cognitive maturity level and whether they have been on hormone therapy for at least a year.

The Endocrine Society similarly offers criteria for when someone might be ready for genital surgery, but specifies that surgeries involving removing the testicles, ovaries or uterus should not happen before age 18.

“Typically any sort of genital-affirming surgeries still are happening at 18 or later,” Olezeski said.

There are no comprehensive statistics on the number of gender-affirming surgeries performed in the U.S., but according to an insurance claims analysis from Reuters and Komodo Health Inc., 776 minors with a diagnosis of gender dysphoria had breast removal surgeries and 56 had genital surgeries from 2019 to 2021.

Research Shows Benefits of Affirming Gender Identity

Young children do not get medical transition treatment, but they do have feelings about their gender and can benefit from support from those around them. “Children start to have a sense of their own gender identity between the ages of 2 1/2 to 3 years old,” Olezeski said.

Programs vary in what age groups they serve, she said, but some do support families of preschool-aged children by answering questions or providing mental health care.

Transgender children are at increased risk of some mental health problems, including anxiety and depression. According to the WPATH guidelines, affirming a child’s gender through day-to-day changes — also known as social transition — may have a positive impact on a child’s mental health. Social transition “may look different for every individual,” Olezeski said. Changes could include going by a different name or pronouns or altering one’s attire or hair style.

Two studies of socially transitioned children — including one with kids as young as 3 — have found minimal or no difference in anxiety and depression compared with non-transgender siblings or other children of similar ages.

“Research substantiates that children who are prepubertal and assert an identity of [transgender and gender diverse] know their gender as clearly and as consistently as their developmentally equivalent peers who identify as cisgender and benefit from the same level of social acceptance,” the AAP guidelines say, adding that differences in how children identify and express their gender are normal.

Social transitions largely take place outside of medical institutions, led by the child and supported by their family members and others around them. However, a family with questions about their child’s gender or social transition may be able to get information from their pediatrician or another medical provider, Olezeski said.

Although not available everywhere, specialized programs may be particularly prepared to offer care to a gender-diverse child and their family, she said. A child may get a referral to one of these programs from a pediatrician, another specialty physician, a mental health care professional or their school, or a parent may seek out one of these programs.

“We have created a space where parents can come with their youth when they’re young to ask questions about how to best support their child: what to do if they have questions, how to get support, what do we know about the best research in terms of how to allow kids space to explore their identity, to explore how they like to express themselves, and then if they do identify as trans or nonbinary, how to support the parents and the youth in that,” Olezeski said of specialized programs. Parents benefit from the support, and then the children also benefit from support from their parents. 

WPATH says that the child should be the one to initiate a social transition by expressing a “strong desire or need” for it after consistently articulating an identity that does not match their sex assigned at birth. A health care provider can then help the family explore benefits and risks. A child simply playing with certain toys, dressing a certain way or enjoying certain activities is not a sign they would benefit from a social transition, the guidelines state.

Previously, assertions children made about their gender were seen as “possibly true” and support was often withheld until an age when identity was believed to become fixed, the AAP guidelines explain. But “more robust and current research suggests that, rather than focusing on who a child will become, valuing them for who they are, even at a young age, fosters secure attachment and resilience, not only for the child but also for the whole family,” the guidelines say.

Mental Health Care Benefits

A gender-diverse child or their family members may benefit from a referral to a psychologist or other mental health professional. However, being transgender or gender-diverse is not in itself a mental health disorder, according to the American Psychological Association, WPATH and other expert groups. These organizations also note that people who are transgender or gender-diverse do not all experience mental health problems or distress about their gender. 

Psychological therapy is not meant to change a child’s gender identity, the WPATH guidelines say. 

The form of therapy a child or a family might receive will depend on their particular needs, Olezeski said. For instance, a young child might receive play-based therapy, since play is how children “work out different things in their life,” she said. A parent might work on strategies to better support their child.

One mental health diagnosis that some gender-diverse people may receive is gender dysphoria. There is disagreement about how useful such a diagnosis is, and receiving such a diagnosis does not necessarily mean someone will decide to undergo a transition, whether social or medical.

UNC Health told us in an email that a gender dysphoria diagnosis “is rarely used” for children.

Very few gender-expansive kids have dysphoria, the spokesperson said. “Gender expansion in childhood is not Gender Dysphoria,” UNC added, attributing the explanation to psychiatric staff (emphasis is UNC’s). “The psychiatric team’s goal is to provide good mental health care and manage safety—this means trying to protect against abuse and bullying and to support families.”

Social media posts incorrectly claim that toddlers are being diagnosed with gender dysphoria based on what toys they play with. One post said: “Three medical schools in North Carolina are diagnosing TODDLERS who play with stereotypically opposite gender toys as having GENDER DYSPHORIA and are beginning to transition them!!”

There are separate criteria for diagnosing gender dysphoria in adults and adolescents versus children, according to the Diagnostic and Statistical Manual of Mental Disorders. For children to receive this diagnosis, they must meet six of eight criteria for a six-month period and experience “clinically significant distress” or impairment in functioning, according to the diagnostic manual. 

A “strong preference for the toys, games or activities stereotypically used or engaged in by the other gender” is one criterion, but children must also meet other criteria, and expressing a strong desire to be another gender or insisting that they are another gender is required.

“People liking to play with different things or liking to wear a diverse set of clothes does not mean that somebody has gender dysphoria,” Olezeski said. “That just means that kids have a breadth of things that they can play with and ways that they can act and things that they can wear.”

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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ECU health spokesperson. Emails with FactCheck.org. 12 May 2023 and 19 May 2023.

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Duke Health spokesperson. Email with FactCheck.org. 12 May 2023.

Olezeski, Christy. Interview with FactCheck.org. 16 May 2023.

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Vanessa Marie | Truth Seeker (indivisible.mama). “Three medical schools in North Carolina are diagnosing TODDLERS who play with stereotypically opposite gender toys as having GENDER DYSPHORIA and are beginning to transition them!! …” Instagram. 7 May 2023.

The post Young Children Do Not Receive Medical Gender Transition Treatment appeared first on FactCheck.org.

SciCheck Digest

An international initiative called the Big Catch-Up aims to increase vaccination among children who have missed routine vaccines during the COVID-19 pandemic. In describing the project, Chelsea Clinton did not say it was time to “force-jab every unvaccinated child in America,” nor will the project impose mandatory vaccinations, contrary to claims.

Full Story

On April 24, multiple organizations, including the World Health Organization and the Bill & Melinda Gates Foundation, announced a joint project called the Big Catch-Up to increase the number of children who are up-to-date on their vaccines. The initiative is particularly focused on 20 countries that are home to especially large numbers of children who missed routine vaccinations during the COVID-19 pandemic. These nations are primarily in Africa and Asia, and do not include the U.S.

Chelsea Clinton, vice chair of the Clinton Foundation, spoke briefly about the Big Catch-Up on April 25 at Fortune’s Brainstorm Health conference, emphasizing the importance of making sure people don’t die of preventable infectious diseases in the U.S. or abroad. 

Many social media posts are sharing an article that uses a fabricated quote in its headline: “Chelsea Clinton: ‘It’s Time To Force-Jab Every Unvaccinated Child in America.’” A spokesperson for Clinton told the Associated Press that Clinton did not say this. We were also unable to find a record of Clinton saying this.

The article was published on the People’s Voice, which is the new home for content from News Punch — a website with a history of spreading falsehoods and undergoing name changes. 

The article does not specify when Clinton supposedly made remarks about “force-jabbing” children but references the Big Catch-Up, stating: “Chelsea – via the Clinton Health Access Initiative (CHAI) – along with the World Health Organization (WHO), UNICEF and the Bill and Melinda Gates Foundation says she hopes to force jab unvaccinated children via a new initiative called ‘The Big Catch-up.’”

However, the Big Catch-Up will not involve forced vaccinations, WHO spokesperson Daniel Epstein told us in an email. “There are no mandatory vaccinations associated with this effort. Some countries require vaccines for children to enroll in school,” he said.

The press release announcing the project stated that missed vaccines during the pandemic have led to outbreaks of measles, diphtheria, polio and yellow fever. Children missed vaccines because health services were overburdened or closed, access to medical supplies was disrupted, and people’s travel was restricted, the release explained.

“To ensure progress on childhood immunization, partners are working with countries to strengthen health care workforces, improve health service delivery, build trust and demand for vaccines within communities, and address gaps and obstacles to restoring immunization,” the release said. It added that further effort needs to go into vaccinating adolescents against human papillomavirus.

And while the Big Catch-Up is a global effort, it will “have a particular focus on the 20 countries where three quarters of the children who missed vaccinations in 2021 live,” the press release said. The U.S. is not on this list.

Clinton mentioned the need for American parents to get their children vaccinated as an aside during her Brainstorm Health conference remarks on the Big Catch-Up. But she did not say anything about forcing parents to get their children vaccinated.

Clinton, April 25: A new effort that we’re a part of is the new initiative launched by the World Health Organization last week to try to catch kids up on their routine immunizations. In 2021 alone, more than 25 million kids under the age of 1 missed at least one routine immunization. And so we’re working with the WHO and the Gates Foundation and others to hopefully have the largest childhood immunization effort ever over the next 18 months to catch as many kids up as possible. Because no one should die of polio or measles or pneumonia, including in this country, where we also need people to be vaccinating their kids.

In a separate part of the same interview not focused on the Big Catch-Up, Clinton spoke about vaccine hesitancy. Again, there was no reference to forcing vaccines on children.

“I spend a lot of time thinking about the really unfortunate, to try to use a not-too-judgmental word, rise in not only vaccine hesitancy and questioning, but outright rejection of vaccines and of science and the scientific process and also too often on our scientists, our epidemiologists, our frontline health care workers,” she said.

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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“Global Partners Announce a New Effort – ‘The Big Catch-up’ – to Vaccinate Millions of Children and Restore Immunization Progress Lost during the Pandemic.” Press release on WHO website. 24 Apr 2023.

Prater, Erin. “Chelsea Clinton Is Working to Stand up ‘the Largest Childhood Immunization Effort Ever’ with the Gates Foundation and the WHO.” Fortune Well. 25 Apr 2023.

Funke, Daniel. “Want to Get Away with Posting Fake News on Facebook? Just Change Your Website Domain.” Poynter. 30 Jan 2019.

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Jones, Brea. “Posts Fabricate Charge Against Bill Gates in Philippines.” FactCheck.org. 10 Mar 2023.

Adl-Tabatabai, Sean. “Chelsea Clinton: ‘It’s Time To Force-Jab Every Unvaccinated Child in America.’” The People’s Voice. 5 May 2023.

The post Posts Share Fake Chelsea Clinton Quote About Global Childhood Vaccination Effort appeared first on FactCheck.org.