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

COVID-19 vaccines substantially reduce the risk of dying from COVID-19, and serious side effects are very rare. Excess deaths among working-age adults in 2021 and 2022 were driven by COVID-19 and other factors, not vaccination. Faulty logic underlies claims that vaccines caused mass disability and economic harm.

How safe are the vaccines?

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COVID-19 vaccination reduces the risk of death from the disease, including in young adults.

Despite overwhelming evidence that COVID-19 vaccines have mitigated the effects of the pandemic, a report called the Vaccine Damage Project, or V-Damage Project, claims that they led to 310,000 excess deaths among Americans ages 25 through 64 in 2021 and 2022. It also baselessly claims the vaccines had a “significant impact” on the number of Americans with disabilities and that COVID-19 vaccines were the “most likely cause” for a large increase in work absences.

The report, which uses the faulty estimates of excess deaths, disabilities and injuries to calculate economic damages, appears on the website of Phinance Technologies — a firm that offers subscriptions to financial reports and consulting services. Phinance says it plans to launch an investment fund.

The alleged findings of the V-Damage Project have been shared widely on social media. Edward Dowd, a founding partner of Phinance Technologies, baselessly tweeted that the “estimated human cost” of the vaccines was 26.6 million injuries, 1.36 million disabilities and 300,000 excess deaths. Dowd has repeatedly said that COVID-19 vaccines are causing large numbers of deaths, claims that have been debunked by other fact-checkers.

Excess deaths associated with the pandemic did continue in 2021 and 2022, but there is no evidence COVID-19 vaccines caused this phenomenon. COVID-19 continued to kill hundreds of thousands of American adults, including nearly 200,000 under age 65 during those two years.

Deaths due to drug overdoses, motor vehicle accidents and alcohol also rose in adults ages 25 to 44 in 2020 and again in 2021, according to Ellen Meara, a professor of health economics and policy at the Harvard T.H. Chan School of Public Health. (She told us in an email that the available data don’t yet provide a complete picture of 2022.) 

“COVID-19 vaccines are the best tool to prevent and reduce complications due to COVID-19,” Lisa George, a Centers for Disease Control and Prevention public affairs specialist, told us in an email. “These vaccines are safe and effective and have undergone the most extensive safety monitoring in U.S. history.”

The number of Americans with disabilities also increased in 2021 and 2022, but negative effects from vaccines are unlikely to explain this rise, given the vaccines’ good safety profile. Finally, sickness-related workplace absences began to rise in 2020, before vaccines were available. A spike in absences in early 2022 coincided with the omicron wave.

Excess Deaths Have a Variety of Causes

Since early in the pandemic, the CDC has been tallying excess deaths — a measure that compares the number of expected deaths in a time period to the actual number of deaths that occur.

The CDC calculates expected deaths assuming the pandemic had not happened, although it notes that “it is increasingly difficult to predict what trends in mortality would have looked like had the pandemic not occurred.”

There have been more than 1.3 million excess deaths in the U.S. since Feb. 1, 2020, according to CDC’s calculation. Many of these are known to be directly the result of COVID-19. Other deaths, the agency explains, could “represent misclassified COVID-19 deaths, or potentially could be indirectly related to the COVID-19 pandemic.” These could include, for example, deaths occurring because of overburdened hospitals, or because of upticks in car crashes or drug overdoses. Especially early in the pandemic, many COVID-19 deaths were missed because of a lack of testing.

According to CDC data, there have been more than 300,000 excess deaths since the beginning of the pandemic if those listing COVID-19 as a cause are excluded. Again, some of these deaths could still be due to COVID-19, but the disease was not listed as an underlying or contributing cause of death.

The V-Damage Project calculates excess deaths due to vaccination using faulty logic.

The report first reasonably states that it’s difficult to distinguish causes of death at the population level. It goes on to incorrectly say: “Starting in the summer of 2021, however, with the introduction of mass vaccinations, the rise in natural immunity by exposure to the virus, and the emergence of milder and more contagious virus strains such as Omicron, it is difficult to argue if Covid-19 had a significant role in excess mortality. Therefore, we can use the total excess mortality in 2021 and 2022 as an estimate for vaccine-related deaths, or at least an estimated upper limit for the vaccine damage.”

There are several things wrong with this statement. First, a substantial number of people died from COVID-19 in the second half of 2021 and in 2022. By the start of summer 2021, there had been a little more than 600,000 COVID-19 deaths in the U.S. The death toll had risen to nearly 1.1 million by the end of 2022. And while the proportion of COVID-19 deaths in older versus younger adults increased over this time period, COVID-19 continued to kill people under age 65.

As noted in a HealthFeedback article discussing a prior claim from Dowd about excess deaths, the timing of excess deaths during the pandemic indicates they are closely tied to COVID-19 deaths, not vaccination. An article from the Associated Press further notes that to show a relationship between vaccines and deaths, one would need to show that vaccinated people — and not unvaccinated people — died at elevated rates. The V-Damage Project doesn’t provide information on deaths in vaccinated versus unvaccinated people.

Second, omicron has been far from benign. Research shows that per infection, omicron has been less severe than earlier variants, in large part because more people have some immunity, either from infection, vaccination or both. There is also some evidence that omicron is naturally less virulent than the delta variant that directly preceded it, although omicron appears to be about as virulent as the original virus.

But omicron spreads more readily to close contacts than delta, and vaccination is less effective at blocking transmission. This all added up to a record-breaking wave of COVID-19 cases in late 2021 and early 2022, which came with significant deaths.

Third, the effects of the pandemic have been complex, and excess deaths related to the pandemic likely have multiple causes. Deaths due to drug overdoses, cardiometabolic disorders and other diseases were already increasing in younger Americans in the decade leading up to the pandemic. The pandemic “accentuated the pre-existing mid-life mortality crisis” in the U.S., researchers wrote in a 2022 study published in Nature Human Behavior. 

As we’ve mentioned, deaths due to drug overdoses, alcohol and motor vehicle accidents all increased in young adults in the U.S. in 2020 and 2021. A recent CDC report also shows an increase in suicides in 2021, including in young adult males.

Finally, there is no evidence that COVID-19 vaccines have killed large numbers of people. The Food and Drug Administration and CDC have multiple systems for monitoring vaccine safety, and they have detected very few deaths caused by the vaccines.

According to a CDC web page updated last month, nine deaths have been linked to a rare clotting disorder caused by the Johnson and Johnson vaccine. “CDC and FDA continue to review reports of death following COVID-19 vaccination and update information as it becomes available,” the web page says.

In fact, the evidence shows that the vaccines have saved lives. Meara pointed to a paper published in the Journal of the American Medical Association that compared death rates in June 2021 through March 2022 in the 10 states with the highest COVID-19 vaccination rates with the primary series versus the 10 states with the lowest rates. Per 100,000 people, there were 75 COVID-19 deaths in the most vaccinated states versus 146 in the least vaccinated states. Excess deaths from all causes were also lower in states with a high proportion of vaccinated individuals.

Serious Adverse Events from COVID-19 Vaccines Are Very Rare

It is unlikely that serious and severe adverse events from COVID-19 vaccines led to rising numbers of people with disabilities in 2021 and 2022, contrary to claims in the V-Damage report. 

The Bureau of Labor Statistics regularly carries out a nationally representative survey, called the Current Population Survey, of around 60,000 U.S. households. The survey data do show an increase in people reporting disabilities in 2021 and 2022.

But Sean Smith, an economist with the Current Population Survey at the BLS, told us in an email that the survey data cannot be used to identify specific disabilities. “We cannot determine from the questions asked if the disability is related to COVID or to an adverse reaction to a vaccine,” he said.

A November 2022 working paper from the nonprofit National Bureau of Economic Research pointed out that, beginning in the second quarter of 2021, the initial rise in the disability rate likely occurred because some people missed earlier interviews and were asked questions about disability in subsequent surveys. “However, since then the rising prevalence of Long COVID and other new sources of disability signal that the increase may reflect an actual increase in the number of [people with disability],” the researchers wrote.

There is extensive data available on the safety of the COVID-19 vaccines, and these data indicate it is unlikely that they caused a significant number of disabilities. The vast majority of side effects following vaccination — like fever and pain at the injection site — are temporary and are not serious.

The V-Damage Report also relies on a paper written by emergency medicine physician Dr. Joseph Fraiman and colleagues to argue that vaccine damages led to the rise in disabilities. As we’ve previously explained, the paper makes an unsubstantiated claim about adverse events based on a flawed reanalysis of the clinical trials of the Pfizer/BioNTech and Moderna mRNA vaccines. 

In reality, serious adverse events were uncommon in large, randomized mRNA vaccine trials and occurred at a similar rate among people who got the vaccines and those who got the placebos.

Finally, the V-Damage report makes unsubstantiated claims that data from v-safe — a text messaging-based system that prompts people to report on their health after vaccination — show a concerning pattern of hospitalization. “Our analysis shows that during the vaccine rollout process, the CDC had live real world data that corroborated the safety signals observed in the clinical trials,” the report says.

In fact, a 2022 analysis of data from v-safe and another vaccine monitoring system called the Vaccine Adverse Event Reporting System showed that most reported adverse events from mRNA vaccines during the first six months of the vaccination program were “mild and short in duration.”

As we’ve previously explained, less than 1% of people enrolled in v-safe sought medical care in the week after each vaccine dose. An even smaller number, less than 0.1%, were hospitalized in the week after receiving each dose. Further, v-safe prompts participants to report any health event or hospitalization, not just ones they believe are related to vaccination. Similarly, VAERS accepts reports of any post-vaccination event, regardless of the cause.

Work Absences Part of Larger Pandemic Trend

Many people take time off from work temporarily due to minor side effects from COVID-19 vaccines, but these absences do not explain a larger pattern of increasing absences since 2020.

The V-Damage Project uses data on side effects from the Pfizer/BioNTech vaccine to claim that full-time workers experienced injuries from COVID-19 vaccines and that the vaccines caused “a degradation of individuals’ immune systems.” But as we’ve noted, very few side effects were serious or lasting, and there is no evidence the vaccines harm the immune system.

The report goes on to cite data from the BLS to claim that these vaccine “injuries” led to absences from work. But work absences due to “own illness, injury, or medical problems” increased at the start of the pandemic, according to Smith, the BLS economist. When counting absences that lasted the entire week, absences due to sickness reached 1.3 million in March 2020 and 2 million in April 2020 — then a record-high number.

The V-Damage Project acknowledges this early-pandemic increase — prior to the arrival of vaccines — but says that the “largest rise in absence rates was in 2022” and that this “occurred after the main impact of the Covid-19 pandemic.”

However, the unusually large number of sickness-related absences in 2022 can be attributed to a spike at the beginning of the year.

Sickness-related absences “further increased to a series high of 3.6 million in January 2022, however this measure dropped to 1.6 million in February 2022 and since then has been similar to the average levels seen in 2020 and 2021,” Smith told us in an email.

As before with disabilities, Smith said that BLS does not have information on the type of illness that caused people to miss work.

But it is worth noting that omicron cases peaked in the U.S. in early 2022, breaking prior records for weekly COVID-19 cases. The BLS data on absences appear more closely tied to COVID-19 cases than vaccinations.

Emma Xiaolu Zang, an assistant professor of sociology at Yale University, who has done research on illness-related work absences early in the pandemic, told us via email that absences in 2022 were likely part of a longer-term pattern of COVID-19-related absences.

“COVID vaccines were unlikely to be the reason for the spike in [sickness-related absences], which started in early 2020,” Zang 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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The post No Evidence Excess Deaths Linked to Vaccines, Contrary to Claims Online appeared first on FactCheck.org.

SciCheck Digest

Since his diagnosis in 1991, NBA player Magic Johnson has repeatedly said he contracted HIV through sexual transmission. But a viral social media post by a spreader of vaccine misinformation falsely claims that Johnson was exposed to the virus from a hepatitis B vaccine.

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In 1991, NBA superstar Earvin “Magic” Johnson retired from the basketball league following his diagnosis earlier that year with the human immunodeficiency virus, or HIV, the virus that can lead to AIDS. 

In his retirement press conference, Johnson announced he would become a public figure for those diagnosed with HIV, “because I want people, young people, to realize that they can practice safe sex.”

Less than a week later, Johnson wrote in Sports Illustrated that he “was infected by having unprotected sex with a woman who has the virus.”

In the over 30 years since his diagnosis, Johnson and his wife, Cookie, have repeatedly affirmed that he contracted HIV through sexual intercourse. 

Yet an Instagram post on Jan. 12 falsely claimed that Johnson contracted HIV through a hepatitis B vaccine program allegedly conducted by the NBA in 1991. The post has received more than 21,000 views and 3,000 likes.

The 37-second video was posted by Judy Mikovits, a former chronic fatigue researcher who has claimed that the COVID-19 pandemic is a conspiracy. The video splices together highlights of her interview with Stew Peters, a conservative radio host who frequently spreads COVID-19 misinformation. 

In the video, Mikovits claims that the medical community “knew who was susceptible, just as they did with Magic Johnson and the NBA in 1991. They gave those men HIV, they did not give them AIDS, in a contaminated hepatitis B vaccine program. They drove an industry through the gain-of-function studies of Tony Fauci, and he knew it since 1983.” 

In the post’s caption, she said, “Why did Magic Johnson test positive for HIV? Because Fauci’s gain of function study used a contaminated Hepatitis B vaccine. Targeting the susceptible then & now!”

The false claim that hepatitis B vaccines were once contaminated with HIV is not new. The first commercially available hepatitis B vaccine used an antigen derived from plasma from individuals with chronic hepatitis B infection, and gay men — who were also at high risk of HIV infection — were known to have donated plasma for the effort. This raised theoretical concerns that even with purification, people might contract HIV from the vaccine. 

But in fact, investigations showed that each of the three inactivation steps used to make the hepatitis vaccine would inactivate HIV and the vaccine did not have detectable HIV in it. Vaccine recipients also lacked any evidence of HIV infection. Today, the hepatitis B vaccine contains no blood products and is made from proteins produced in yeast.

Similar to Mikovits, some people have incorrectly claimed that HIV originated in a hepatitis B vaccine trial that enrolled gay men and began in 1978, since some of the first AIDS cases were participants in the trials. But evidence contradicts that idea. Among the gay men in the trial, there was no association between when they were given a vaccine and when they developed antibodies to HIV. Also, by analyzing viral genomes, scientists have demonstrated that HIV was already circulating in the U.S. by 1971.

As we said, Johnson contracted HIV through sexual intercourse, not from a hepatitis B vaccination program. 

In response to Mikovits’ claims, Alexia Grevious Henderson, vice president at Magic Johnson Enterprises, told the Associated Press that Johnson has never suggested that any vaccine contributed to him contracting HIV. Johnson has also noted the positive role Fauci — a former HIV researcher who recently retired from his role as director of the National Institute of Allergy and Infectious Diseases — had in the basketball star’s life, helping him accept the implications of his diagnosis.

We did not find any support for the claim that the NBA ran a hepatitis B vaccination program in 1991, or that any hepatitis B vaccine was a part of gain-of-function research conducted by Fauci. 

We have reached out to the NBA for comment on whether any such vaccination program occurred and to the National Institutes of Health on whether there was any gain-of-function research behind the development of a hepatitis B vaccine, but we did not hear back.

Mikovits did not respond to a request for comment on the evidence behind her claim.

This isn’t the first time Johnson’s status as an HIV-positive patient has led to viral misinformation about him. As we’ve written before, social media posts falsely claimed Johnson has donated blood for people with COVID-19. He hasn’t donated HIV-infected blood for any medical reason.

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

Sources

Akpan, Nsikan. “America’s HIV outbreak started in this city, 10 years before anyone noticed.” PBS. 26 Oct 2016.

Cannon, Lou and Anthony Cotton. “Johnson’s HIV caused by sex.” Washington Post. 9 Nov 1991.

Chicago Tribune. “Nov. 6, 1992: Magic discusses how he got HIV.” 6 Nov 1992.

“CNN – Magic Johnson HIV Announcement (1991).” Video. YouTube. 31 Jul 2021.

drjudyamikovits. “Thank you Stew Peters for another great interview. Why did Magic Johnson test positive for HIV? Because Fauci’s gain of function study used a contaminated Hepatitis B vaccine. Targeting the susceptible then & now! Watch the full interview here, link also available on my website:.” Instagram. 12 Jan 2023.

Fichera, Angelo, et al. “The Falsehoods of the ‘Plandemic’ Video.” FactCheck.org. Updated 29 Jun 2021.

Francis, Donald P., et al. “The Safety of the Hepatitis B Vaccine: Inactivation of the AIDS Virus During Routine Vaccine Manufacture.” Journal of the American Medical Association. 15 Aug 1986.

Frontline. “Endgame: AIDS in Black America.” PBS. 10 Jul 2012.

Hale Spencer, Saranac. “COVID-19 Is Caused by a Virus, Not Snake Venom.” FactCheck.org. 18 Apr 2022.

Hale Spencer, Saranac. “Social Media Posts Misrepresent FDA’s COVID-19 Vaccine Safety Research.” FactCheck.org. 23 Dec 2022.

Hale Spencer, Saranac, et al. “‘Died Suddenly’ Pushes Bogus Depopulation Theory.” FactCheck.org. 1 Dec 2022.

Jones, Brea. “Social Media Posts Falsely Claim Magic Johnson Donated Blood for People with COVID-19.” FactCheck.org. 23 Aug 2022.

Los Angeles Times. “Magic Blames Weakness in Numbers : HIV: He says he can’t pinpoint when he was infected because there were many women. He says he had no homosexual experiences.” 13 Nov 1991.

Marcelo, Philip. “False claims circulate about Magic Johnson’s HIV diagnosis.” Associated Press. 13 Jan 2023.

NBA.com. “NBA History: Magic Johnson retires from basketball in 1991.” 6 Nov 2018.

National Institutes of Health. “Anthony S. Fauci, M.D.” Accessed 18 Jan 2023.

Offit, Paul A. “A Look at Each Vaccine: Hepatitis B Vaccine.” Children’s Hospital of Philadelphia. 13 May 2022.

Oliveira, Nelson. “Magic Johnson opens up about his health, career 30 years after HIV diagnosis: ‘You just sit there and say, what does this mean? Am I gonna die?’” CBS Mornings. 4 Nov 2021.

World Health Organization. “Hepatitis B” webpage. Accessed 19 Jan 2023.

Worobey, Michael, et al. “1970s and ‘Patient 0’ HIV-1 genomes illuminate early HIV/AIDS history in North America.” Nature. 26 Oct 2016.

The post Magic Johnson Did Not Contract HIV from a Vaccine, Contrary to Online Claim appeared first on FactCheck.org.

SciCheck Digest

A 62-year-old bodybuilder who had heart disease died after contracting COVID-19. But vaccine opponents are falsely suggesting that he died from the COVID-19 vaccine. He didn’t. He’d been vaccinated 18 months before his death.

How do we know vaccines are safe?

Full Story

The long-standing fallacy that athletes have been dropping dead due to COVID-19 vaccination has been thoroughly debunked, but still continues to spread.

One of the most recent additions to this aggregate claim is the death of Doug Brignole, a 62-year-old bodybuilder who died at his California home on Oct. 13.

Vaccine opponents latched onto his death, in particular, because he had advocated for taking the COVID-19 vaccines when they initially became available.

On April 4, 2021, Brignole posted to Facebook a picture of himself getting the shot and wrote: “I’m vaccinated ! Well, the first of two. Let’s get this done so we can get back to traveling, going to concerts, and having fun. My vaccine was yesterday, and I had no problem with it. My deltoid was a bit sore, but otherwise fine. We’re all in this together, so let’s do our share to beat it.”

The following day, Brignole responded to commenters who expressed skepticism about the vaccines. He posted: “I have enough confidence in the vaccine, based on my research, to get it done. Those of you who think the vaccine kills people can use me as a test. If I die, you were right. If I don’t die, and have no ill effects, you were wrong, and should admit it (at least to yourselves). Better yet, you should admit that you were misled, and tell the world who misled you, so other people can benefit by avoiding those fear mongers.”

A year and a half later, Brignole died. It had nothing to do with the vaccine.

Despite that, posts on social media have highlighted Brignole’s statement from the spring of 2021 and suggested that his unrelated death somehow serves as evidence for the unsupported assertion that COVID-19 vaccines have caused widespread deaths. Brignole’s initial Facebook post about getting vaccinated — from the spring of 2021 — is now filled with comments suggesting that the vaccine killed him.

The Los Angeles County Department of Medical Examiner-Coroner’s report for Brignole does not mention the vaccine at all. Rather, it explains that he had been feeling sick in the days before his death. A friend cited in the report said that Brignole had recently traveled to Atlantic City for a competition and came back with a “flu.” A nasal swab used during the autopsy tested positive for COVID-19.

“Mr. Brignole’s underlying medical conditions, including heart disease from atherosclerosis would have made him less able to tolerate the effects of COVID-19, contributing to his death,” the autopsy report said.

His cause of death was listed as COVID-19 with atherosclerotic cardiovascular disease — hardening of the arteries — listed as a contributing factor.

Heart disease has been known to increase the risk of developing severe COVID-19 that could result in death since the early days of the pandemic. We don’t know at the time of his death what Brignole’s status was on booster shots — he didn’t appear to post about it on social media if he did get a booster. But a study published in Oxford University Press’s journal Clinical Infectious Diseases looked at the death certificates for 106 people who got COVID-19 after they were vaccinated and died from January through April 2021 in the U.S. Researchers found that 14% of them had a heart condition similar to Brignole’s.

So, the suggestion that Brignole died of the vaccine — which he lived with for a year and half — is contradicted by the autopsy report.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Kiely, Eugene, et al. “Article Makes Unfounded Claims Linking Athletes’ Injuries, Deaths to Vaccines.” FactCheck.org. 17 Dec 2021.

Thompson, Stuart. “No, athletes are not dying from Covid-19 vaccines.” New York Times. 28 Jan 2022.

Kessler, Glenn. “How the falsehood of athletes dying of coronavirus vaccines spread.” Washington Post. 1 Feb 2022.

Teper, Lonnie. “Doug Brignole, Back in the Game.” Iron Man Magazine. 9 Oct 2009.

Los Angeles County Department of Medical Examiner-Coroner. Douglas Brignole. Accessed 3 Nov 2022.

Los Angeles County Department of Medical Examiner-Coroner. Douglas Brignole — autopsy report. 21 Oct 2022.

Centers for Disease Control and Prevention. “People with Certain Medical Conditions.” Updated 19 Oct 2022.

Lee Lewis, Dara K. “How does cardiovascular disease increase the risk of severe illness and death from COVID-19?” Harvard Health Publishing. 2 Apr 2020.

François Watkins, Louise K., et al. “Characteristics of Reported Deaths Among Fully Vaccinated Persons With Coronavirus Disease 2019—United States, January–April 2021.” Clinical Infectious Diseases. 29 Jan 2022.

Mayo Clinic. Arteriosclerosis / atherosclerosis. Accessed 2 Nov 2022.

The post Bodybuilder Died from COVID-19, Not the Vaccine as Social Media Posts Claim appeared first on FactCheck.org.

SciCheck Digest

A rigorous vaccine safety monitoring system has shown that the COVID-19 vaccines are safe and only rarely have serious side effects. But an article shared on social media falsely says that CDC data show more than 18 million people “were injured so badly” by a Pfizer/BioNTech or Moderna COVID-19 vaccine “that they had to go to the hospital.”

How do we know vaccines are safe?

How can I report a potential safety issue?

Full Story

Over 632 million COVID-19 vaccine doses have been administered in the United States, under what the Centers for Disease Control and Prevention calls “the most intense safety monitoring program” in the country’s history. 

After receiving a vaccine, many people experience mild to moderate symptoms, such as headache, fatigue, fever or pain at the injection site. But these side effects go away in a couple of days and are not considered a safety concern, but rather a sign that the vaccine is working. 

Side effects that require medical attention can also occur, but they are the exception. 

Yet an article online inaccurately reported that “according to the CDC’s own internal data” more than 18 million people “were injured so badly” from a dose of the Pfizer/BioNTech or Moderna COVID-19 vaccines “that they had to go to the hospital.” 

“Court Orders CDC to Release Data Showing 18 Million Vaccine Injuries in America,” an Oct. 14 headline from Technocracy News & Trends, which was later shared on social media, misleadingly claimed. 

The post refers to data from a CDC safety monitoring system, called v-safe, that the anti-vaccination group Informed Consent Action Network obtained through a Freedom of Information Act lawsuit. According to the group’s review of the data, out of around 10.1 million v-safe users, more than 780,000, or over 7.7%, “had a health event requiring medical attention, emergency room intervention, and/or hospitalization.” This is “alarming,” it claims, and “should have caused the CDC to immediately shut down its Covid-19 vaccine program.”

A dubious website, Technocracy News & Trends, then went further and misinterpreted the analysis to falsely claim that “about 800,000” people “reported being hospitalized by their COVID vaccination.” The website also rounded the 7.7% figure to 8% and applied it to the vaccinated population of the U.S. to say that “18 million of the 230 million people who received at least one shot may have been hospitalized with an adverse reaction.”

But v-safe collects data on any health event, vaccine-related or not, and the 7.7% — even if taken at face value — was for any kind of medical attention, not just hospitalizations, up to a year after vaccination. It’s inaccurate to say the analysis identified that many hospitalizations after vaccination and misleading to suggest that every event reported was caused by a vaccine. Importantly, a published analysis of v-safe data that shows less than 1% of participants reported receiving medical care in the first week after getting a vaccine. 

The CDC said it couldn’t comment on the analysis. But a spokesperson told us in an email that according to the CDC’s data, in the first week after vaccination “reports of seeking any medical care (including telehealth appointments) range from 1-3% (depending on vaccine, age group and dose). V-safe data have shown low rates of medical care after vaccination, particularly hospitalization.”

Over 10 million v-safe users have completed 146 million health surveys, the CDC told us. 

“V-safe is not designed to identify causal relationships between vaccines and adverse events,” Dr. Edward Belongia, director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute and an expert in vaccine safety, told us in a phone interview. 

V-safe is a vaccine surveillance program that uses text messages and online surveys to monitor people’s health after getting a COVID-19 vaccine. Every day for a week after each dose of a vaccine, participants who voluntarily opt into the program get messages in which they are asked how they feel that day. They are also asked to report certain symptoms from a pre-populated list, including chills, headache and nausea, or something not listed; and about any health impacts, such as being unable to work, unable to do daily activities, or having to get medical attention. Follow-up texts are sent once a week for the following six weeks and at three, six and 12 months after vaccination. V-safe users are not directed to only report symptoms or health impacts they believe are connected to the shots.

“It does not have the level of detail and granularity needed to accurately assess whether those events are causally related. And you know, there’s no comparison group there, everybody in v-safe is vaccinated. And so it’s impossible to determine whether a vaccine caused a particular adverse event just based on v-safe data,” Belongia told us.

The system is part of a larger early alert reporting system that allows experts to monitor the safety of the vaccines. Belongia, and other experts, say v-safe has limitations. But he says the tool has been helpful to observe common side effects of the vaccines such as pain at the injection site, headache, muscle aches or fever. 

“And what we’re seeing is largely consistent with what was seen in the clinical trials: that these symptoms are very common, they’re mild to moderate, they resolved over two to three days, and so there’s really nothing surprising there,” he said.

The data collected through v-safe is not accessible to the public in the way the data from other systems like the Vaccine Adverse Event Reporting System is. Instead, the information is communicated to the public through multiple studies that analyze v-safe data in the CDC’s Morbidity and Mortality Weekly Report and other journals, and in presentations to the Advisory Committee on Immunization Practices. According to the CDC, v-safe data have been presented in 11 meetings since the rollout of the vaccines — in December 2020; January, March, June, September and October 2021; and in January, April, May, June and September 2022. 

Some findings of these studies are that the second dose of the primary series caused more participants to report mild and temporary symptoms or being unable to do normal activity, and that the second booster caused fewer of the expected side effects, such as pain at the site of injection, than the first one. According to the CDC, when the COVID-19 vaccines started to be administered, v-safe was critical in identifying early reports of a severe allergic reaction that occurs rarely after vaccinations. 

One study, published in the Lancet Infectious Diseases in March, analyzed v-safe reports between Dec. 14, 2020, and June 14, 2021, after the administration of the Pfizer/BioNTech and the Moderna COVID-19 vaccines. According to its findings, less than 1% of v-safe users reported receiving medical care in the first week after getting a dose of the primary series of either vaccine, and a very small proportion (0.2% or fewer) reported an emergency room visit or hospitalization. Again, even those medical care visits are not necessarily caused by the vaccine and could be coincidental.

ICAN’s Misleading Analysis

Informed Consent Action Network is a Texas-based group founded by Del Bigtree, an anti-vaccination activist. The group has filed several vaccine-related lawsuits against the CDC, the Food and Drug Administration and the National Institutes of Health. ICAN sued the CDC in December 2021, and again in May 2022, following FOIA requests to obtain all data submitted to v-safe since Jan. 1, 2020. The v-safe program only started after the COVID-19 vaccines were authorized in December 2020. 

In August, the CDC agreed to publish on its website the data collected from more than 10 million v-safe participants by Sept. 30. The database would cover reports submitted between Dec. 14, 2020, and July 31, 2022, and would omit any personal identifiers. The agency told Reuters “technical and administrative” issues prevented it from publishing the data on time. Instead, the CDC handed the data directly to ICAN, which published its own analysis on Oct. 3.

On its website, ICAN does not explain the methods used for its analysis. But it mentions the data are limited to the 10 million v-safe users and to the pre-populated fields checked by them, not the information users can add in text boxes. According to the group’s dashboard, the data are drawn from check-ins that occurred up to a year after a vaccine dose. The group also published five downloadable files with raw v-safe data. 

FactCheck.org reached out to Aaron Siri and other representatives of Siri & Glimstad, who filed the FOIA litigation for ICAN, but we didn’t hear back from them. We also tried to access the raw data presented, but we couldn’t open the biggest file containing information regarding the health check-ins. 

We were able to access one of the files containing symptoms and health impacts, which included 116,294 reports. Out of these reports, 1,046, or 0.9%, were reports of receiving medical care of any kind, and this included multiple reports from the same person over time. Out of those, only seven were for hospitalizations, two of which were for the same person on two consecutive days. 

Belongia, the vaccine safety expert, told us the numbers provided by ICAN, including the more than 780,000 users who reported requiring medical care of any kind, are “uninterpetable.” 

“We don’t know what the background rate in the population is from v-safe. What would that number have been in a group of people who hadn’t gotten the vaccine?” he said. 

Since health problems, including hospitalizations, occur in the population every day, it’s not uncommon for them to happen after vaccination for reasons unrelated to the vaccine. That’s why it’s important to see if a particular event is happening more frequently after vaccination, which could indicate an issue. 

The analysis doesn’t mention how long after vaccination a user required medical attention, but included responses up to a year after vaccination, which could explain the difference between ICAN’s numbers and the CDC’s published data. Siri told Reuters that ICAN thought it was important to look beyond one week, since some potential vaccine-related side effects could appear weeks after vaccination. But most side effects occur soon after vaccination, so including longer intervals would include more events that are unrelated to the vaccine.

A user may have gone to a doctor for a completely different reason six months after a vaccine, and, if following v-safe instructions properly, would report it to the system. That user would get a follow-up call from v-safe, for the agency to get more information. But as we said, v-safe doesn’t have the ability to know if any particular event, including a hospitalization, was caused by the vaccine or not.

“And so in order to answer questions like that, in terms of relative risk, you need something like the Vaccine Safety DataLink or VSD, which uses medical records from millions of people around the country, and immunization records to implement scientifically valid studies to determine if there’s an elevated risk after vaccination for particular adverse events,” Belongia said, referring to a network of nine integrated health care organizations, including his, that conducts active vaccine safety surveillance. 

“What we’re actually seeing in the data is the exact opposite of what is being suggested by groups like ICAN — these vaccines are very safe. With, you know, a few very rare known exceptions,” Belongia said. “But overall, it’s very clear that the benefits of the vaccines greatly outweigh the risks.”

Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

COVID Data Tracker. CDC. Accessed 27 Oct 2022. 

Selected Adverse Events Reported after COVID-19 Vaccination. CDC. Updated 24 Oct 2022. Accessed 27 Oct 2022. 

V-safe After Vaccination Health Checker. CDC. Updated 18 Jul 2022. Accessed 27 Oct 2022. 

Sparber, Sami. “Texas-based anti-vaccine group received federal bailout funds in May as pandemic raged.” The Texas Tribune. 18 Jan 2021. 

“BREAKING NEWS: ICAN OBTAINS CDC V-SAFE DATA.” ICAN. 3 Oct 2022. 

Rosenblum, Hannah G., et al. “Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe.” Lancet Infectious Diseases. 22 Jun 2022. 

Belongia, Edward. Director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute. Phone interview with FactCheck.org. 27 Oct 2022

“Share your COVID-19 vaccination experience with v-safe.” CDC. You Tube. 21 Mar 2021.

COVID-19 Vaccine Reporting Systems. CDC. Accessed 27 Oct 2022. 

Michelle Gomez, Amanda. “V-Safe: How Everyday People Help the CDC Track Covid Vaccine Safety With Their Phones.” KHN. 7 Sep 2021. 

Hause, Anne M., et al. “Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022.” MMWR. 19 Aug 2022. 

Hause, Anne M., et al. “Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022.” MMWR. 29 Jul 2022. 

Hause, Anne M., et al. “Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021–February 6, 2022.” MMWR. 18 Feb 2022. 

Hause, Anne M., et al. “Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US.” JAMA Network Open. 18 Feb 2022. 1 Jul 2022.

ACIP Meeting Information. CDC. Accessed 27 Oct 2022. 

CDC COVID-19 Response Team; Food and Drug Administration. “Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020.” MMWR. 15 Jan 2021. 

Greene, Jenna. “New data is out on COVID vaccine injury claims. What’s to make of it?” Reuters. 12 Oct 2022. 

Vaccine Safety Datalink (VSD). CDC. Accessed 27 Oct 2022. 

Sharan, Martha. CDC Media Relations. Email to FactCheck.org. 25 Oct 2022. 

The post Posts Distort Misleading Analysis of COVID-19 Vaccine Safety Data appeared first on FactCheck.org.

]]> https://www.factcheck.org/2022/10/scicheck-floridas-covid-19-vaccination-analysis-is-flawed-experts-say/ Thu, 13 Oct 2022 18:57:47 +0000 https://www.factcheck.org/?p=223868 The state of Florida recently announced that it was no longer recommending that younger males receive mRNA COVID-19 vaccines, based on an unpublished analysis that purportedly found an increased risk of cardiac-related death following vaccination. But experts who specialize in the unique method used in the analysis say it was not properly done -- and even if it had been, the findings would not mean that individuals should not get vaccinated.

The post Florida’s COVID-19 Vaccination Analysis Is Flawed, Experts Say appeared first on FactCheck.org.

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The state of Florida recently announced that it was no longer recommending that younger males receive mRNA COVID-19 vaccines, based on an unpublished analysis that purportedly found an increased risk of cardiac-related death following vaccination. But experts who specialize in the unique method used in the analysis say it was not properly done.

Even if it had been, the findings would not mean that individuals should not get vaccinated. The analysis includes no risk-to-benefit comparison, and by its own admission is “preliminary” and “should be interpreted with caution.”

On Oct. 7, the Florida Department of Health said in a press release that the state’s surgeon general, Dr. Joseph A. Ladapo, was issuing new guidance about COVID-19 vaccination after the department conducted an analysis that found “an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination.”

“With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the press release continued. “As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines.”

Update, Jan. 5: On Jan. 4, the Washington Post reported that a faculty council committee at the University of Florida College of Medicine, where Ladapo is on the faculty, determined that the state’s analysis was “seriously flawed” and should not have been used as the basis to recommend against vaccination. The committee said this raised concerns that Ladapo performed “careless, irregular, or contentious research practices” in violation of the school’s policies on research integrity. The school, however, said it would not be investigating further.

No other state has made such a recommendation, and it’s counter to guidance from the Centers for Disease Control and Prevention and other medical authorities. The mRNA vaccines, which include the Pfizer/BioNTech and Moderna vaccines, have been shown to be remarkably safe in clinical trials and in follow-up safety studies. There is a heightened risk of inflammation of the heart muscle or surrounding tissue, known as myocarditis or pericarditis, particularly in younger males after a second dose. The condition, however, is rare and most patients recover within a few months.

The same day of the press release, Ladapo, who is known for questioning the safety of COVID-19 vaccines and has promoted unproven COVID-19 treatments, shared the analysis on Twitter. The social media company initially removed his tweet for violating its misinformation policies, but restored it two days later.

Ladapo was appointed to his post by Republican Gov. Ron DeSantis in September 2021 after the previous surgeon general resigned.

During Ladapo’s tenure, the state of Florida has also recommended against vaccinating babies and children below the age of 5 and against vaccinating healthy children between the ages of 5 and 17. This advice is also at odds with that of the American Academy of Pediatrics, the CDC and numerous medical experts.

Florida’s Analysis

The Florida Department of Health’s analysis is a self-controlled case series, which is an unusual method that by design only includes people who experienced a possible side effect after vaccination — in this case, death.

Instead of comparing deaths among vaccinated or unvaccinated people, as a more standard study might do, the comparison in the Florida study is between the number of deaths during a defined “risk” period versus a control, or “baseline,” period, for each person.

“The key benefit of SCCS is that each individual serves as a self-control, so in principle this design adjusts for confounding that is typically a major issue when comparing separate ‘vaccinated’ and ‘unvaccinated’ groups,” University of Pennsylvania biostatistician Jeffrey S. Morris told us in an email, referring to other factors that could affect an outcome.

Self-controlled case series can be powerful tools, but they can also be tricky to do, particularly when dealing with a terminal event such as death — and as we’ll explain, experts in the technique said they found the department’s analysis to be flawed.

But first, a quick review of what the analysis, which is unpublished and does not even list any authors, claimed to find. 

According to the methods section, the analysis included adults living in Florida who died within 25 weeks of a COVID-19 vaccination, but excluded those who received boosters or who had a documented coronavirus infection or a COVID-19-associated death.

It found that in the first 28 days after vaccination, there was no increase in all-cause deaths, relative to the remaining 25-week period — and for those 60 years and older, vaccination reduced the risk of death slightly. But there was a small, statistically significant increase in cardiac-related deaths for the entire group, which were defined by certain codes written on the death certificates.

Broken down by age, only two groups — 25- to 39-year-olds and those 60 and older — had statistically significant increases in cardiac-related deaths, with the strongest effect in the younger group. The statistically significant effects were limited to males. When just looking at the mRNA vaccines, there was an 84% increased risk of cardiac-related death among males 18 to 39, based on 20 deaths in the “risk” period and 52 in the “baseline” period.

A key problem, however, is that the authors did not account for multiple vaccine doses, which can bias the result, experts told us.

“The flaw in the calculation is that the timing of the death determines the observed exposure pattern, and that this is not taken into account in this method of analysis,” Paddy Farrington, a professor emeritus of statistics at the Open University in the U.K., told us in an email.

Farrington specializes in SCCS and is an author on three of the six papers the analysis cited, including a review paper covering “recommendations for best practice” using the method in vaccine safety studies.

He has helped conduct a couple SCCS studies of COVID-19 vaccine safety, which have not turned up any concerns for the mRNA vaccines.

To understand the issue in the Florida analysis, Farrington said to consider a hypothetical scenario in which there are two doses given four weeks apart and in which deaths occur at a constant rate of one per week, unrelated to vaccination. For a 29-week period, there would be 29 total deaths: four in the first four weeks after dose one, four in the first four weeks after dose two, and 21 in the 21 subsequent weeks.

But if one were to do the analysis that Florida’s health department did, comparing the rates of death in the four weeks after the last dose given, Farrington said, there would be eight deaths within four weeks of a vaccine dose. The apparent rate ratio, he said, would be 2, suggesting a doubling of the risk. But this would be an error.

“This is biased upwards: the true rate ratio is 1, since deaths arise at a constant rate of 1 per week irrespective of vaccination,” he said.

The correct way to do the analysis, Farrington said, is to use a specific methodology he published in January in the journal Statistics in Medicine, which solves these issues. “The method is difficult to explain,” he said, “but it takes into account all the doses given.”

The authors of the Florida analysis appear to have modeled their approach on an unpublished paper posted to a preprint server medRxiv in March, which they cited. The preprint, by scientists in the U.K., also evaluated the risk of all-cause and cardiac death following COVID-19 vaccination by doing an SCCS analysis on the last vaccine dose given. 

Unlike the Florida analysis, however, it did not identify any increased risk of death after vaccination. It also performed a similar analysis after a positive COVID-19 test — which the Florida analysis did not do — and found a large increase in the frequency of both all-cause and cardiac-related deaths after infection in people who were unvaccinated.

The lead author of the preprint, Vahé Nafilyan, a principal statistician for the U.K.’s Office for National Statistics, told us in an email that the preprint was “conducted very quickly to respond to rising concerns about the safety of vaccine in young people,” and his group had rerun the analysis using the methodology Farrington recommended. The new paper is currently under review, he said, and the preprint is being released this week.

But Nafilyan also said his team had a work-around to avoid the concern Farrington had with analyzing the last vaccine doses.

“In the initial analysis, we purposely restricted the follow-up period to 12 weeks – the minimum separation between doses,” he said in an email, referring to the longer interval used in the U.K. when the vaccines were first rolled out. “This was a quick way to circumvent the issue. The Florida study does not apply such a restriction and that is the issue.”

“For the Florida study, it would be far more tricky since the minimum gap between doses in the US was 3 weeks,” he added, “making it impossible to use the same ‘trick’ as in our initial analysis.”

Farrington agreed that this difference between the studies would mean the U.K. paper “is probably OK, whereas the Florida one is not!”

Additional Concerns

Other critics have raised additional concerns and caveats about the Florida analysis. For example, cardiac deaths were not checked by reviewing medical records, but instead were defined by the presence of certain codes on death certificates, which aren’t a guarantee that a person died from a cardiac problem.

As Dr. Kristen Panthagani, an emergency medicine resident at Yale New Haven Hospital, wrote in a blog post, the codes included cardiac arrest, “which simply means ‘the heart stopped’ and can be the terminal event for many different diseases, not just cardiac issues.”

The authors say as much in the limitations section, noting the study “cannot determine the causative nature of a participant’s death” and the “underlying cause of death may not be cardiac-related.”

The limitations section, notably, also mentions that the increased risk in cardiac deaths the analysis observed in the overall population and the 60 and over group could be due to confounding by age in the older group. Because so many more deaths occurred in older people, when the 60-plus group was removed, there was no longer any statistically significant result for cardiac-related deaths after vaccination, for mRNA vaccines, or males who received mRNA vaccines.

Panthagani and others have said that given the relatively small number of deaths in the “risk” period for younger males receiving mRNA vaccines — 20 — a change of just a few because of inaccurate coding could render the finding insignificant.

Another issue is how exactly the authors dealt with COVID-19. People with COVID-19 listed as a cause or contributing factor to death were correctly excluded from the analysis, but it’s not entirely clear if the same was done for people who tested positive for COVID-19. This could mean that some of the cardiac deaths being attributed to the vaccine are actually from the disease, Panthagani noted.

In one part of the write-up, the analysis says people with positive COVID-19 tests were excluded, but in another, “COVID testing status was unknown for those who did not die of/with COVID.”

On Oct. 10, Ladapo responded to some of the criticisms on Twitter, arguing that it didn’t matter if the diagnosis codes for cardiac deaths were “imperfect,” since they were the same for all groups. He also said the state “used all of our data resources,” including test results, to exclude people with documented coronavirus infection.

But if that’s the case, then what is written in the limitations section is incorrect. We reached out to the Florida Department of Health to clarify this issue, among others, but did not hear back.

Morris, the University of Pennsylvania biostatistician, told us that the analysis might be fine “if properly executed,” but he couldn’t verify if that was the case given the lack of detail in the write-up — and he had “several unresolved questions that make me wonder.”

Along with the confusion over the COVID-19 testing and “potential bias from considering the last dose only,” Morris said that he did not understand why some of the average follow-up times in some cases were longer than the 25-week period set for the entire analysis. He said he had asked for more information from the state health department on this and other issues, but had not received a reply.

Morris and Farrington also wondered why the analysis excluded booster doses. And critically, despite a mention of “infection” in the title and in another sentence of the discussion — which could be a typo — Morris did not understand why the analysis did not also evaluate the risk of cardiac deaths following coronavirus infection. Not only is this what the U.K. study did, but this would be “a relevant factor to weight against any vaccine-related risks.”

Update, April 19: The Tampa Bay Times reported in April that earlier versions of the Florida analysis included additional data and were at odds with the state’s decision to recommend against vaccination in young men. One draft concluded that COVID-19 vaccination was not associated with any increased risk of death. Another draft found a “small increased risk for cardiac-related mortality” after vaccination, but also found that the risk of death, either from any cause or cardiac-related, was many times higher after infection. Three other drafts noted that once accounting for additional vaccine doses — the main issue experts identified with the Florida analysis — the small increased risk was no longer statistically significant.

The U.K. study was published in Nature Communications in March. It found no significant increase in death from any cause or cardiac mortality after mRNA vaccination.

Update, May 2: Based on a draft obtained through a public information request, Politico reported on April 24 that Ladapo was responsible for some edits to the analysis that altered the conclusions and presented vaccination as risky for young men.

Analysis Poor Basis for Changing Vaccine Recommendations

Indeed, several critics have pointed out that even if the analysis is taken at face value, it doesn’t include a comparison of the risks of the vaccine with its benefits, so the analysis itself fails to show that the risks outweigh the benefits. And as a single unpublished, preliminary analysis that contradicts other published papers, it’s hardly enough to justify modifying public health guidance.

“There is a large literature on the safety of mRNA vaccines, and recommendations should be based on a comprehensive overview of the available evidence, not any one single study (even less so if it is unpublished),” Farrington said. “What I find extraordinary in the Florida saga,” he added, “is that recommendations on vaccination can be made based on a single (in this case, flawed) study, when there is ample other evidence to the contrary.”

As we said, myocarditis and pericarditis have been identified as rare side effects of the mRNA vaccines.  Studies have consistently shown that for the overall population, the risk of myocarditis is much greater after a coronavirus infection than after vaccination. For some groups, such as men under 40, the risk of myocarditis may be higher after vaccination than after an infection, as a large U.K. study recently found for the second dose of the Moderna vaccine. But considering all the other possible bad outcomes from COVID-19, numerous teams of experts have concluded that the benefits of the vaccine outweigh the risks, even for younger males.

“Florida’s public health recommendation is specifically for men age 18-39. Despite the fact that this age group is at lower risk of severe complications of COVID-19 than older Americans, CDC, FDA, and other federal agencies continuously have found that the evidence is clear: the benefits of vaccines clearly outweigh any risks,” Sarah Lovenheim, assistant secretary for public affairs at the department of Health & Human Services, said in a statement. “This is why FDA authorized, and CDC recommended, that all individuals in this age group get vaccinated against COVID-19.”

Lovenheim called Florida’s decision “flawed and a far cry from the science.”

According to an expert consensus paper published in March by the American College of Cardiology, “a very favorable benefit-to-risk ratio exists with the COVID-19 vaccine for all age and sex groups evaluated thus far.”

While it’s conceivable that some deaths have occurred because of the vaccines, this risk is exceedingly small. During a CDC vaccine advisory committee meeting in February, the agency presented data showing that 13 deaths involving myocarditis had been reported among people 30 years and younger who had received a first or second mRNA dose. However, none of these was thought to be vaccine-related. We asked the CDC for an update on the numbers, but didn’t receive a response.

Studies suggest that post-vaccination myocarditis is milder than typical viral myocarditis and that most people recover within three months.

In interviews with Politico and the Washington Post, Ladapo defended the analysis and his decision to stop recommending the mRNA vaccines for young males, given high levels of immunity in the population now.

Ladapo told the Post that he hoped his former mentor, Harvard economist David Cutler, would endorse the methods used in the analysis. But according to the Post, Cutler said the analysis was flawed and should not serve as the basis for state vaccine policy.

“If I was a reviewer at a journal, I would recommend rejecting it,” Cutler said.

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Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

The post Florida’s COVID-19 Vaccination Analysis Is Flawed, Experts Say appeared first on FactCheck.org.

]]> https://www.factcheck.org/2022/10/scicheck-no-indication-breast-milk-after-vaccination-unsafe-despite-posts-about-new-study/ Tue, 04 Oct 2022 21:03:15 +0000 https://www.factcheck.org/?p=223291 No evidence suggests it’s dangerous for babies to consume breast milk from mothers who get vaccinated against COVID-19. Online posts, however, have pointed to a study that found temporary, trace amounts of vaccine mRNA in milk after vaccination to claim that the vaccines are unsafe.

The post No Indication Breast Milk After Vaccination Unsafe, Despite Posts About New Study appeared first on FactCheck.org.

]]>

SciCheck Digest

No evidence suggests it’s dangerous for babies to consume breast milk from mothers who get vaccinated against COVID-19. Online posts, however, have pointed to a study that found temporary, trace amounts of vaccine mRNA in milk after vaccination to claim that the vaccines are unsafe.

How do we know vaccines are safe?

How do we know vaccines are safe?

No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.

One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”

Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.

Another monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time.

In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks.

The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. 

For more, see “How safe are the vaccines?”

Link to this

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Full Story

There is no evidence that babies are harmed by drinking breast milk from mothers who have received a COVID-19 vaccine. On the contrary, vaccinated mothers produce antibodies and even some immune cells that recognize the coronavirus, or SARS-CoV-2, in breast milk, which may provide some protection to infants.

The Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists and the World Health Organization all recommend that lactating mothers get vaccinated, and none of them recommend withholding breast milk after vaccination.

Online posts, however, have seized on a newly published article in JAMA Pediatrics to argue that maternal vaccination is harmful to infants.

“7 out of 11 women had mRNA in their breast milk. This isn’t just a disaster for infants, it’s more proof that the mRNA/LNP in the shots hits practically every cell in the body,” one Sept. 26 Instagram post reads, sharing screenshots of the paper and quoting a tweet from Alex Berenson. 

Berenson is a former New York Times reporter who has repeatedly spread misinformation about COVID-19 and the vaccines.

The study did find mRNA from the Pfizer/BioNTech or Moderna COVID-19 vaccines in breast milk samples from several women (it was actually five out of 11 women, not seven, as Berenson said, although he corrected himself on Twitter). But as we’ll explain, the amount of mRNA was exceedingly small, was detected only for up to 48 hours after vaccination, and does not mean that vaccination is hazardous to infants.

The Pfizer/BioNTech and Moderna COVID-19 vaccines contain modified messenger RNA, or mRNA, which provides the instructions for cells to briefly make some coronavirus spike proteins. This prompts the body to generate a protective immune response, so that if someone encounters SARS-CoV-2, the immune system will already be familiar with the virus and be better able to fight it off. For both vaccines, the mRNA is wrapped in fatty molecules known as lipid nanoparticles to protect and ferry the mRNA into cells, since naked mRNA is otherwise degraded too quickly.

The American College of Obstetricians and Gynecologists told us in a statement that while additional research on the safety of COVID-19 vaccination during lactation is welcome, the new findings did not change the group’s guidance that women do not need to avoid starting breastfeeding or to stop breastfeeding after vaccination.

“The findings based on a sample of breast milk in 5 women that could be measured (of the eleven) is highly speculative and does not currently represent strong evidence against breastfeeding at any point after mRNA COVID-19 vaccination,” the organization said. “Additionally, the fetal gut when consuming breast milk within the first 48 hours after a maternal vaccination would be expected to rapidly degrade any mRNA that entered it. However, even if mRNA were to be absorbed, the notion that it would be harmful to an infant is not supported by the data presented or any data currently available.”

JAMA Pediatrics Study

The JAMA Pediatrics study, which was published by researchers at NYU Long Island School of Medicine, looked for the presence of vaccine mRNA in breast milk samples collected from 11 women, between one hour and five days after vaccination with either the Pfizer/BioNTech or Moderna vaccines.

Trace amounts of vaccine mRNA were found in seven samples from five women, up to 45 hours after vaccination. For two of these women, no vaccine mRNA was detectable in whole milk, but some was identified when the researchers used a method to concentrate the number of extracellular vesicles, or tiny fat-coated sacs, to make it more likely they could detect the mRNA. The vesicles are known to be present naturally in breast milk.

The amounts of vaccine mRNA in the milk were exceedingly small — less than 12 picograms per milliliter of whole milk, and within the vesicles, not more than 17 picograms per milliliter. These amounts are under 0.02 parts per billion.

The paper acknowledged that the study had few participants, and that no tests were performed to determine whether the mRNA was in any way functional and could be used to make protein.

“The sporadic presence and trace quantities of COVID-19 vaccine mRNA detected in EBM suggest that breastfeeding after COVID-19 mRNA vaccination is safe, particularly beyond 48 hours after vaccination,” the authors wrote, referring to expressed breast milk. 

Still, the authors thought the finding was important. “We believe it is safe to breastfeed after maternal COVID-19 vaccination. However, caution is warranted about breastfeeding children younger than 6 months in the first 48 hours after maternal vaccination until more safety studies are conducted,” they added.

On the day of publication, JAMA Pediatrics highlighted this part of the paper, writing in a tweet sharing the article, “Trace amounts of #COVID19 vaccine mRNAs were detected in the breast milk of some lactating women. Caution is warranted regarding #breastfeeding infants younger than six months in the first two days after maternal COVID-19 vaccination.”

Screenshots of this tweet, along with those of the paper, were subsequently shared on social media — some with little or no commentary, while others were more overt in suggesting the new results meant it was unsafe for vaccinated mothers to breastfeed or that lactating mothers shouldn’t get vaccinated.

Multiple experts, including some dismayed by the journal’s tweet, say the findings are not concerning.

For one, as Victoria Male, a lecturer in reproductive immunology at Imperial College London, told us, and as she details in a continually updated online explainer, the results are not particularly new.

Two other papers have also found vaccine mRNA in breast milk from some — but not all — of a small number of lactating women, always in extremely small amounts. (Two other studies, which did not attempt to concentrate potential mRNA in the samples, were unable to detect any vaccine mRNA.)

“It’s also important to note that, although tiny amounts of vaccine mRNA can be detected in some people, this doesn’t necessarily mean that vaccine is present,” Male said in an email. “Another study, that looked for non-mRNA components that would suggest active vaccine was present in breast milk, could not find any, and there is no evidence that this small amount of mRNA could have any negative impact on the health of babies.”

“Studies that have looked at the health of breastfed babies shortly after their mothers have been vaccinated have also found no problems,” she continued. “Taken together, this body of evidence suggests that there should be no problem with breastfeeding shortly after you have been vaccinated.”

She added that the Royal College of Obstetricians and Gynaecologists in the U.K. says that women should not stop breastfeeding to get vaccinated against COVID-19. This is similar to what ACOG, the American Academy of Pediatrics, the Academy of Breastfeeding Medicine and the WHO all say.

“Breastfeeding after vaccination is safe for the baby,” ACOG explains in an FAQ. “There is no need to stop breastfeeding if you want to get a vaccine. When you get vaccinated, the antibodies made by your body may be passed through breast milk and may help protect your child from the virus.”

The lead author, neonatologist Dr. Nazeeh Hanna, defended the inclusion of the “caution is warranted” line in his paper in an interview with us, but explained that what this meant was that if mothers had any concerns about the mRNA in milk, they could “pump and dump” for the 48 hours after a vaccination. He was not suggesting that lactating mothers not get vaccinated.

Pumping and dumping refers to expressing breast milk, usually with a breast pump machine, and then discarding that milk. Hanna suggested that mothers who opt for this approach pump extra milk before vaccination to feed their babies for the two days that they would be throwing out milk, rather than using formula.

“If you want to be on the safe side, and be more cautious … don’t expose the babies for now, because there could be some concern — could be,” he said.

The rationale for the caution, Hanna said, applied to babies 6 months and younger, since vaccines have not been tested or authorized in younger children. He said he didn’t think the trace mRNA would harm babies — and in theory, it could be good — but because it’s unknown, people should be informed about the temporary presence of the mRNA in breast milk.

But other experts do not think there’s enough of a possibility of harm to warrant such caution.

Study Results Not Concerning, Experts Say

“There is absolutely no justification to withhold breastmilk after getting the vaccine, even with the detection of trace amounts of mRNA. There is mRNA from many sources in breastmilk, which is not dangerous and also unlikely to survive the digestive tract of the baby anyways,” Dr. Stephanie Gaw, a maternal-fetal medicine physician scientist at the University of California, San Francisco, told us in an email.

“The clinical or biological significance of these trace amounts is not studied, and most scientist[s] would consider it not clinically relevant,” she continued. “Suggesting that mothers pump and dump is reckless and potentially harmful to the mother and baby (withholds safe nutrition from the baby, disrupts the breastfeeding relationship, and imposes stress on the days) with absolutely no justification.”

Gaw was senior author on an earlier JAMA Pediatrics paper that did not use special methods to increase the ability to detect trace amounts of mRNA, and found no vaccine mRNA in breast milk samples from seven mothers. She also authored a study of 50 pairs of lactating mothers and babies, which failed to find any evidence that polyethylene glycol, one of the vaccine ingredients that helps protect the mRNA, made it into milk. That study also did not observe any severe side effects in mothers or their infants.

It’s worth noting that the amount of mRNA detected in breast milk is nowhere near the amount in a vaccine. Even at the highest detected concentration of mRNA in the JAMA Pediatrics paper, a baby would have to consume 256 liters of breast milk to reach the 3 microgram amount in a single vaccine dose of the Pfizer/BioNTech vaccine, which is authorized for children as young as 6 months. Babies consume at most a bit more than a liter of breast milk a day.

(For this reason, even if in theory mRNA transfer in breast milk could be good for infants, it’s difficult to imagine how they would get enough to see any effect. The possible benefits of vaccination via breast milk would be due to the transfer of protective antibodies or immune cells — not through mRNA.)

Male, of Imperial College London, was not necessarily against “pumping and dumping,” but also said that stopping breastfeeding, even for a short time, is “not without harms of its own, particularly for people who are not used to expressing milk, and babies who are not used to taking bottles. It’s important for people to fully consider these issues, with support from their doctor or midwife if necessary.”

Both Gaw and Male noted that having mRNA in breast milk is normal, and people ingest and digest mRNA all the time from food and the environment. Hanna said that the mRNA in extracellular vesicles in breast milk would survive digestion, and could be absorbed by the gastrointestinal tract. A few studies have found that some breast milk vesicles carrying proteins or microRNAs (a different RNA from mRNA) can survive digestion.

But as virologist Angela Rasmussen of the University of Saskatchewan told us, the JAMA Pediatrics study didn’t assess whether the vesicles with vaccine mRNA were able to survive digestion. Even if they did, she said, “the quantities of mRNA are so minute, they will have no biological impact.”

“Furthermore,” she added, “given that thousands—maybe millions—of lactating people have been vaccinated and there is no indication whatsoever that this has any observable clinical impact on nursing infants, I’d be a lot more ‘cautious’ about putting my infant at risk of getting COVID by not getting vaccinated or boosted.”

Correction, Oct. 6: We corrected two links to studies and the description of the vaccine ingredient polyethylene glycol.

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Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Whited, Noah and Jorge Cervantes. “Antibodies Against SARS-CoV-2 in Human Breast Milk After Vaccination: A Systematic Review and Meta-Analysis.” Breastfeeding Medicine. 8 Jun 2022.

Gonçalves, Juliana et al. “Secretory IgA and T cells targeting SARS-CoV-2 spike protein are transferred to the breastmilk upon mRNA vaccination.” Cell Reports Medicine. 1 Dec 2021.

“COVID-19 Vaccines While Pregnant or Breastfeeding.” CDC. Accessed 3 Oct 2022.

“COVID-19 Vaccines: Answers From Ob-Gyns.” ACOG. Accessed 3 Oct 2022.

“Frequently asked questions: COVID-19 vaccines and breastfeeding based on WHO interim recommendations.” WHO. 15 Sep 2021.

American College of Obstetricians and Gynecologists. Statement sent to FactCheck.org. 29 Sep 2022. 

Hanna, Nazeeh et al. “Detection of Messenger RNA COVID-19 Vaccines in Human Breast Milk.” JAMA Pediatrics. 26 Sep 2022.

JAMA Pediatrics (@JAMAPediatrics). “Trace amounts of #COVID19 vaccine mRNAs were detected in the breast milk of some lactating women. Caution is warranted regarding #breastfeeding infants younger than six months in the first two days after maternal COVID-19 vaccination. #Research https://ja.ma/3UIKEjS #Research.” Twitter. 26 Sep 2022.

Male, Viki. Lecturer in Reproductive Immunology at Imperial College London. Emails to FactCheck.org. 27 Sep 2022.

Male, Viki. “Explainer on COVID vaccination, fertility, pregnancy and breastfeeding.” Updated 2 Oct 2022.

Low, Jia Ming et al. “Codominant IgG and IgA expression with minimal vaccine mRNA in milk of BNT162b2 vaccinees.” NPJ Vaccines. 19 Aug 2021.

Mattar, Cintra NZ et al. “Addressing anti-syncytin antibody levels, and fertility and breastfeeding concerns, following BNT162B2 COVID-19 mRNA vaccination.” medRxiv. 25 May 2021. 

Golan, Yarden et al. “COVID-19 mRNA Vaccination in Lactation: Assessment of Adverse Events and Vaccine Related Antibodies in Mother-Infant Dyads.” Frontiers in Immunology. 3 Nov 2021.

Yeo, Kee Thai et al. “Neutralizing Activity and SARS-CoV-2 Vaccine mRNA Persistence in Serum and Breastmilk After BNT162b2 Vaccination in Lactating Women.” Frontiers in Immunology. 11 Jan 2022. 

O’Reilly, Daniel et al. “Perspective: The Role of Human Breast-Milk Extracellular Vesicles in Child Health and Disease.” Advances in Nutrition. 24 Aug 2020.

“COVID-19 vaccines, pregnancy and breastfeeding FAQs.” Royal College of Obstetricians and Gynaecologists. Accessed 4 Oct 2022.

“Breastfeeding During the COVID-19 Pandemic.” American Academy of Pediatrics. 2021.“Considerations for COVID-19 Vaccination in Lactation.” Statement. Academy of Breastfeeding Medicine. 14 Dec 2020.

Hanna, Nazeeh. Neonatologist, Department of Pediatrics, NYU Langone Hospital–Long Island, NYU Long Island School of Medicine, Mineola, New York. Phone interview with FactCheck.org. 29 Sep 2022. 

Gaw, Stephanie. Associate professor and maternal-fetal medicine physician scientist at the University of California, San Francisco. Emails sent to FactCheck.org. 3 Oct 2022. 

Golan, Yarden et al. “Evaluation of Messenger RNA From COVID-19 BTN162b2 and mRNA-1273 Vaccines in Human Milk.” JAMA Pediatrics. 6 Jul 2021. 

Golan, Yarden et al. “COVID-19 mRNA Vaccination in Lactation: Assessment of Adverse Events and Vaccine Related Antibodies in Mother-Infant Dyads.” Frontiers of Immunology. 3 Nov 2021. 

“Overview of COVID-19 Vaccines.” CDC. Updated 24 Aug 2021.

Cross, Ryan. “Without these lipid shells, there would be no mRNA vaccines for COVID-19.” C&EN. 6 Mar 2021.

Feeding Guide for the First Year. Johns Hopkins Medicine. Updated 26 Jul 2019, accessed 4 Oct 2022. 

Ramussen, Angela. Virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan. Emails sent to FactCheck.org. 29 Sep 2022. 

The post No Indication Breast Milk After Vaccination Unsafe, Despite Posts About New Study appeared first on FactCheck.org.

]]> https://www.factcheck.org/2022/09/scicheck-viral-posts-spin-falsehood-out-of-denmarks-covid-19-booster-drive/ Fri, 16 Sep 2022 23:08:18 +0000 https://www.factcheck.org/?p=222468 Denmark announced a plan for its fall COVID-19 vaccination drive, saying it will offer omicron-specific booster shots to high-risk individuals, including everyone 50 and over. But U.S.-based misinformation peddlers misleadingly suggest that means the shots are unsafe for those under 50. The Danish Health Authority said that is a misinterpretation.

The post Viral Posts Spin Falsehood Out of Denmark’s COVID-19 Booster Drive appeared first on FactCheck.org.

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SciCheck Digest

Denmark announced a plan for its fall COVID-19 vaccination drive, saying it will offer omicron-specific booster shots to high-risk individuals, including everyone 50 and over. But U.S.-based misinformation peddlers misleadingly suggest that means the shots are unsafe for those under 50. The Danish Health Authority said that is a misinterpretation.

How do we know vaccines are safe?

How do we know vaccines are safe?

No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.

One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”

Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.

Another monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time.

In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks.

The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. 

For more, see “How safe are the vaccines?”

Link to this

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Full Story

Booster shots formulated to better protect against severe illness from the currently circulating variants of the virus that causes COVID-19 are now available.

Which means that bogus claims from those who spread vaccine misinformation are making the rounds, too.

Conservative talk show host Clay Travis, for example, said in a video clip posted on Facebook: “Denmark is banning the COVID shot for anyone under the age of 50 because it is not safe.”

Like others who have made similar claims, Travis cited a suggestive Sept. 14 Substack post from Alex Berenson, a former New York Times reporter who has sown doubt about the vaccines during the pandemic.

But it’s not true that Denmark is “banning” the boosters for those under 50 due to safety concerns.

Rather, the Danish Health Authority is focusing its fall vaccination drive on those who are most vulnerable to severe illness, hospitalization and death from COVID-19 — which means those who are over 60. But the Danish health system is offering the boosters to everyone 50 and older as a precaution, as it has explained in the publicly available report on the reasoning and planned implementation of the program.

The current Danish vaccination program — announced on Sept. 13 — is aimed at 2.5 million people, Tina Gustavsen, a spokeswoman for the Danish Health Authority, told us in an email. The total population of Denmark is 5.9 million, according to the World Bank.

Referring to the plan to give booster shots to roughly half the country, she said, “It stands to reason that any health authority on the planet would only do this when they are convinced that the vaccines are safe.”

In addition to anyone 50 and older, the booster shots will be given to those under 50 who have underlying health conditions that put them at higher risk for severe illness, those who work in health care or eldercare, relatives of those who are at high risk and pregnant women.

“The aim of the vaccination programme against covid-19 this autumn is to get us well through the winter by protecting people who are at the highest risk of becoming severely ill and by avoiding that the Danish healthcare system, especially the hospitals, are overburdened,” the Danish Health Authority explained in an English-language post on its website.

Further, Gustavsen told us by email, “Data also show that the population under the age of 50 is expected to have significant immunity, both as a result of previous infection and previous vaccination. On this basis, and due to the fact that very few persons under the age of 50 are at risk of running a serious course of covid-19 disease, the Danish Health Authority does not currently plan on recommending vaccination to persons under the age of 18 as a group. Children and young people who are at increased risk of a serious course of covid-19 will continue to have the option of vaccination after individual assessment.”

We asked if those under 50 who don’t fit the increased risk criteria could get a booster if they wanted. Gustavsen said, “In Denmark, the vaccination strategy against covid-19 in the fall/winter 2022/23 is to prevent serious illness, hospitalization and death from covid-19 – not to prevent infections.”

She also noted that primary vaccination continues to be available for those under 50.

As of Sept. 13, about 82% of Denmark’s population was fully vaccinated, compared to about 68% in the U.S.

“We have achieved very high population immunity in Denmark,” the Danish Health Authority wrote in an explainer about the new booster drive. “This is due both to the high adherence to the vaccination programme and to many people previously having been infected with covid-19. … We expect that a large part of the population will become infected with covid-19 during the autumn, and we therefore want to vaccinate those having the highest risk so that they are protected from severe illness if they become infected.”

So, the claim that Denmark has banned those under 50 from getting vaccinated against COVID-19 due to safety concerns is false. The country has a high rate of adherence to vaccination and is focusing its current booster drive on those who are most vulnerable, which accounts for nearly half the population.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

U.S. Food and Drug Administration. Press release. “Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose.” 31 Aug. 2022.

Robertson, Lori. “Misrepresentation of Germany’s Data on Unverified COVID-19 Vaccine Side Effects.” FactCheck.org. 3 Aug 2022.

Robertson, Lori. “Why It’s Easy to Misinterpret Numbers of Deaths Among the Vaccinated.” FactCheck.org. 1 Nov 2021.

Gustavsen, Tina. Spokeswoman, Danish Health Authority. Email to FactCheck.org. 16 Sep 2022.

Danish Health Authority. Vaccinationsprogram mod covid-19 i efterår/vinter 2022/23. 2 Sep 2022.

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Danish Health Authority. Vaccination against covid-19. Accessed 15 Sep 2022.

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]]> https://www.factcheck.org/2022/03/scicheck-posts-misinterpret-pfizer-covid-19-vaccine-safety-monitoring-document/ Fri, 18 Mar 2022 23:29:03 +0000 https://www.factcheck.org/?p=215371 A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company’s COVID-19 vaccine. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events.

The post Posts Misinterpret Pfizer COVID-19 Vaccine Safety Monitoring Document appeared first on FactCheck.org.

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SciCheck Digest

A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company’s COVID-19 vaccine. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. Many posts also wrongly assume that a long list of health issues Pfizer is monitoring for occurred and were due to vaccination.

How do we know vaccines are safe?

How do we know vaccines are safe?

No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.

One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”

Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.

Another monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time.

In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks.

The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. 

For more, see “How safe are the vaccines?”

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How safe are the vaccines?

How safe are the vaccines?

More than half a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain — or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines “have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.”

A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, according to the CDC.

To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldn’t receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.

There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.

Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.

Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated “responded well to medicine and rest and felt better quickly.”

The Johnson & Johnson vaccine has been linked to an increased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30 to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination and include severe or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.

According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April, the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldn’t get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021, the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&J’s.

The J&J vaccine has also been linked to an increased risk of Guillain-Barré Syndrome, a rare disorder in which the immune system attacks nerve cells. Most people who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.

Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.

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Full Story

After more than 1 billion doses administered worldwide — including more than 325 million in the U.S. — and more than a year of safety monitoring, the Pfizer/BioNTech COVID-19 vaccine is considered to be very safe. 

Many people experience temporary symptoms, such as fever, headache or pain at the site of injection. But those aren’t dangerous and are signs that the vaccine is working and the body is beginning to mount a protective immune response. More serious side effects can occur, but are rare.

The vaccine was first granted an emergency use authorization by the FDA in December 2020, based on a large phase 3 randomized controlled trial and other studies. In August 2021, it received full approval, after review of the manufacturing process and ongoing trial results and safety monitoring.

A flurry of articles and videos online are now misinterpreting a Pfizer document released by the FDA as part of a Freedom of Information Act request. The posts incorrectly claim that it shows the vaccine is unsafe and is evidence that this was hidden from the public.

“One year ago, these were side effects that Pfizer knew about,” conservative commentator Liz Wheeler says in an Instagram post, before highlighting a long list of so-called adverse events of special interest in the document’s appendix. 

“Look at how many side effects, adverse events, were recorded before the end of February of last year,” she said. “It’s shocking. It essentially admits that … this vaccine can cause you to miscarry your baby, this can cause you to die in any number of truly horrific ways.”

A press release from Children’s Health Defense, Robert F. Kennedy Jr.’s anti-vaccination organization, similarly highlights the appendix and calls the document a “bombshell” that “should put an immediate end to the Pfizer COVID vaccines.”

John Campbell, a nurse educator in the U.K., whom we’ve written about before, also discussed the document in a popular YouTube video posted on March 9. In the video, which garnered more than 1.5 million views in just three days, he incorrectly implies that the vaccine caused the reported health problems. He also suggests Dr. Janet Woodcock, the acting FDA commissioner when the agency gave full approval to the Pfizer vaccine, was wrong to say that “millions of people have already safely received COVID-19 vaccines.”

“So how would you say it’s safe, when this document is indicating there’s been 1,223-associated deaths?” he asks.

He, too, focuses on the appendix’s list of adverse events of special interest. “The list is long, quite incredible really,” he says. “Why weren’t we made aware of these at the time? Because if we were aware of them at the time, we could have had an index of suspicion for them and kept an eye out for them.”

But, as we’ll explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccine’s continued safety.

Misunderstanding ‘Adverse Events’ 

All of these posts misunderstand what is being reported in the Pfizer document. The document is an analysis of adverse events, or health issues reported following vaccination, regardless of whether they were caused by the vaccine. Tracking of such events is useful for companies and regulators to identify possible safety signals, particularly of rare events that would not have been possible to detect in clinical trials.

This particular document covers the first three months of the vaccine’s rollout, and incorporates adverse event reports from across the globe. Through February 2021, it says, there were 42,086 reports of individuals reporting adverse events, including 1,223 deaths.

While on the surface those numbers could be alarming, it’s critical to understand that an adverse event is simply an event that has occurred after vaccination — it does not mean the vaccine necessarily caused the problem. And many of the events are likely to be purely coincidental.

“By definition, an adverse event is a temporal association,” Dr. Paul Beninger, a pharmacovigilance expert at the Tufts University School of Medicine, told us, referring to the timing of the event.

“Any health problem that happens after vaccination is considered an adverse event following immunization,” the Centers for Disease Control and Prevention explains. “An adverse event can be a true adverse reaction, also known as a side effect, that is related to the vaccine, or a coincidental event that happened following vaccination.”

Beninger said it was inaccurate for Campbell to say the reported deaths were “associated” with Pfizer’s vaccine. “They’re temporally associated, that’s the reason why they were reported. But the assessment’s not there to show that they were causally related,” he said. “You cannot call them vaccine-associated.”

Similarly, it’s not correct to call the adverse events “side effects,” as Wheeler did.

This confusion about adverse events is common and has been a frequent issue before with people distorting data from the ​​Vaccine Adverse Event Reporting System in the U.S. to argue that vaccines are unsafe, as we’ve written repeatedly before.

Because a variety of health problems, including death, occur in the population every day, it’s expected that many of these will be reported after vaccination, even if they have nothing to do with the vaccine. The challenge is to see whether the frequency of a particular event is elevated above the background rate, which could indicate a possible problem.

The released Pfizer document, it should be said, reviews the adverse events in groups according to organ type, noting each time that the evidence does not suggest a new safety signal. The analysis concludes that Pfizer’s post-marketing data “confirms a favorable benefit: risk balance” for its vaccine, and that the company will continue its monitoring “to assure patient safety.”

The first pages of the document, too, explicitly address many of the limitations of adverse event reporting to help properly interpret the data — limitations those posting alarming stories about the document appear to have ignored.

Pfizer’s analysis notes that the company’s safety database contains cases of adverse events “regardless of causality assessment” and says that numerous factors can influence whether an adverse event is reported, and that the “spontaneous reporting system should be used for signal detection.”

“An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication,” it continues.

Far from proving that the Pfizer/BioNTech vaccine isn’t safe, the Pfizer document is evidence of the vaccine’s continued safety, Beninger said.

He also said that Woodcock was completely right to say that millions of COVID-19 vaccine doses had been administered safely. “Absolutely yes, categorically, no question,” he said.

Of Campbell, Beninger said, “His comments are very superficial and a lot of it is quite naive. The fact that all of those reports were there is proof of nothing, it all needs to be assessed.”

In the video, Campbell himself acknowledges that he struggled to read the document.

Misconstruing the Appendix

Many posts also err in their interpretation of the Pfizer document’s appendix, which is an alphabetical list of 1,291 adverse events of special interest. In her post, Wheeler even calls the appendix “the relevant part,” and Campbell argues the public should have been aware of the conditions so people could have “kept an eye out for them.”

But the appendix, Beninger said, was actually just a list of the things Pfizer was monitoring for — not a list of health problems that have been observed after vaccination or that had been shown to be due to vaccination.

One clue comes from its formatting, he said. “When events have actually happened, there is a breakdown,” he said. “They’re not presented in a massive alphabetical listing from A to Z.”

FDA FOIA

Some of the misleading online claims also center around how the Pfizer document was obtained and suggest there was a government cover-up, so we’ll provide some background on the topic.

As we’ve already established, there’s nothing to indicate that there was any identified safety issue, and therefore, there’s no evidence that regulators failed to share any important safety information with the public.

The document was released by the FDA in response to a Freedom of Information Act request from Public Health and Medical Professionals for Transparency. The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine — or around 329,000 pages, plus other files — four days after the agency gave full approval to the vaccine.

The FDA did not oppose releasing the information, but denied the group’s request for expedited processing, leading PHMPT to sue the agency in federal court in September, as MedPage Today has explained. 

The FDA argued that the group’s request would require releasing 80,000 pages a month, which the agency said had never happened before with any FOIA request, and was difficult if not impossible with its current staffers, who would need to go through the documents line by line and redact exempted material. The FDA proposed releasing 500 pages a month instead, which it said was the standard rate. 

PHMPT, meanwhile, countered that that proposed rate would take nearly 55 years — and it was “difficult to imagine a greater need for transparency” than making the vaccine documents available.

On Jan. 6, a judge in North Texas recognized the “‘unduly burdensome’ challenges” of the FOIA, but sided with the plaintiff, concluding the request was of “paramount public importance.” He set the deadline for the first tranche of documents for Jan. 31, with another 55,000 pages to be released every month. At that pace, all of the information will be released by the end of the summer.

PHMPT then posted the documents on its website. Shortly thereafter, misleading or false claims began circulating online about the safety of the Pfizer/BioNTech vaccine using the documents, which our colleagues at Health Feedback have also addressed.

As MedPage Today has explained, the FDA has already released summaries of the data it has reviewed, and the FOIA documents “may not be material to an overall analysis of the vaccine’s safety and efficacy.” Zach Zalewski, a regulatory strategy consultant at Avalere Health, told the outlet, “There’s a risk of cherry picking and taking things out of context.”

Beninger, however, said the FDA had been “a bit tone deaf to what’s going on around them,” and said he thought that the agency should have been more attentive. “I just think you have to virtually bend over backwards to be transparent,” he said.

It’s worth noting that while Campbell calls the people who have joined PHMPT “prestigious” and “highly qualified,” the list is primarily notable for its inclusion of multiple individuals who have made dubious claims about COVID-19 or the vaccines. Among several others, the list of signatories includes Idaho pathologist Dr. Ryan Cole, who has baselessly said that the vaccines cause cancer, and Dr. Stella Immanuel, who has falsely promoted hydroxychloroquine as a COVID-19 “cure” and has previously claimed that some medicines are made of space alien DNA.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is 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 goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

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