HHS ‘FAQ’ Distorts Data on COVID-19 Vaccination During Childhood and Pregnancy – FactCheck.org

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A document the Department of Health and Human Services distributed to members of Congress to justify recent changes to COVID-19 vaccine recommendations misrepresented scientific research to make unfounded claims about vaccine safety for pregnant people and children.

HHS Secretary Robert F. Kennedy Jr. publicly announced May 27 that the Centers for Disease Control and Prevention had stopped recommending COVID-19 vaccination for healthy pregnant women or healthy children. He did not work through regular channels for updating the CDC’s vaccine schedule, which normally would include a presentation of the relevant evidence at a meeting open to the public and input from expert advisers.

Rather, Politico reported, in the days before Kennedy’s announcement, HHS circulated a document to lawmakers titled “COVID Recommendation FAQ,” citing seven studies as evidence justifying Kennedy in repealing the recommendations. (The CDC did remove its recommendation that pregnant adults get vaccinated. While Kennedy has said the vaccines are no longer recommended for healthy children, the CDC vaccine schedule now lists them as vaccines that may be given under shared clinical decision-making. There’s a full recommendation only for kids who are moderately to severely immunocompromised.)

A closer look at the citations shows that the authors of the document misrepresented the studies’ findings and cited research that itself misused data.

For instance, one study the document claimed showed higher rates of miscarriage in pregnant women who got COVID-19 vaccinations in fact concluded that there was no increased risk after adjusting for other factors that could influence the risk of miscarriage. Another study cited as showing placental blood clots after vaccination did not look at this outcome at all.

Yet another cited study misused data from a vaccine safety surveillance system to exaggerate the risk of myocarditis, a real but rare side effect of COVID-19 vaccination that can also occur following COVID-19. The study, co-authored by people with a history of spreading false and misleading information on vaccines, now carries an “expression of concern” that states the publisher is investigating “potential issues with the research methodology and conclusions and author conflicts of interest.”

The distortion of data is part of a larger pattern. Since taking the helm at HHS, Kennedy has repeatedly misrepresented scientific data on topics ranging from measles to chronic disease, as have HHS spokespeople and reports.

In fact, the safety and effectiveness of the mRNA COVID-19 vaccines in pregnancy “have been established in studies undertaken independently by scientists working for governments, healthcare systems and universities all over the world, including in the USA,” Victoria Male, a senior lecturer in reproductive immunology at Imperial College London, told us via email.

And while there have been legitimate differences of opinion on whether or how often healthy children need COVID-19 vaccines, the HHS document omits evidence showing safety and effectiveness in this group while overstating risks.

The document “ignores the overwhelming real-world data on vaccine safety and benefit in children and pregnant women,” vaccinologist Helen Petousis-Harris of the University of Auckland told us in an email. She added that it misuses safety surveillance data and “cherry-picks quotes and studies while ignoring the broader scientific consensus and context.” She subsequently posted a version of her comments in a blog post.

Studies Support Safety of COVID-19 Vaccination During Pregnancy

Studies have found COVID-19 vaccination during pregnancy is safe and protects both the mother from severe disease and the baby from hospitalization from COVID-19 during the early months of life.

“The data remain clear: getting vaccinated against COVID-19 is still the best way for pregnant people to protect themselves and their pregnancies,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement reacting to the FAQ. “It is alarming that HHS is propagating misinformation.”

Going against this extensive record, the HHS document raised unfounded concerns about COVID-19 vaccines and pregnancy outcomes.

As we’ve said, the document misrepresented a paper showing no increased risk of miscarriage after COVID-19 vaccination, using it to support the claim that studies “showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy.”

Dr. Maria Velez, a reproductive epidemiologist at McGill University who was the lead author of the study, told Politico that her work had been “misinterpreted” and did not find an association between COVID-19 vaccination and miscarriage after adjusting for a variety of factors that could impact both miscarriage risk and the likelihood of getting vaccinated. Adjustment for such factors is necessary before concluding that there may be an association.

Citing the study “as evidence for harm is a clear misrepresentation,” Petousis-Harris said.

We asked HHS if it stood behind its claims or could further explain this and other citations.

“The study cited showed a higher percentage of fetal loss before 20 weeks among pregnant women who received the COVID-19 vaccine compared to those who did not,” Press Secretary Emily Hilliard told us via email. “The underlying data speaks for itself—and it raises legitimate safety concerns. HHS will not ignore that evidence or downplay early pregnancy loss.”

Hilliard went on to call it “disturbing that FactCheck.org appears to dismiss the significance of the underlying data. Every miscarriage is a tragedy. Suggesting otherwise is offensive to the families who have experienced that loss.”

But Male called it “inappropriate” to calculate miscarriage rates without accounting for risk factors, pointing out that “the vaccinated groups were more likely to have comorbidities that put them at risk of miscarriage than the unvaccinated group.”

Furthermore, the larger body of research also has not found an association between COVID-19 vaccination and miscarriage.

This body of work includes a second study the HHS document cited to justify its unfounded claim on fetal loss. The study, which looked at outcomes for patients who underwent in vitro fertilization, again found that getting COVID-19 vaccines was not associated with pregnancy loss.

The HHS document also misleadingly cited a study it said “showed statistically significant increases in preterm birth.” One of the paper’s sub-analyses that looked just at the second trimester did find a statistically significant association between vaccination and increased preterm birth. But overall, there wasn’t an association between vaccination and preterm birth. And another sub-analysis, of the third trimester, found the opposite — an association between vaccination and a reduced risk of preterm birth.

Male pointed out that the study authors themselves said that some factor they did not take into account may have influenced both the preterm birth rate and whether someone got vaccinated in the second trimester.

Preterm births occurred on average 14.3 weeks after the first vaccination, and there were no preterm births within two weeks of vaccination. If the vaccines were in fact causing preterm births, at least some would be expected to occur more quickly after vaccination and at a greater variety of points in pregnancy, Adam Kucharski, an epidemiologist and mathematician at the London School of Hygiene & Tropical Medicine, wrote in a June 18 blog post responding to the HHS document.

The scientific literature in general indicates that COVID-19 vaccines do not cause preterm birth. Male said that “three other studies published almost simultaneously with this one confirmed no increased risk of preterm birth associated with COVID vaccination in the second trimester.”

Kucharski also wrote that studies that do many comparisons are liable to find some associations simply by chance.

“Just like a roulette player having another spin, the more times we compare things in a dataset, the bigger the chance that we might mistake a random coincidence for a genuine, consistent effect,” he said.

Another citation appears unrelated to the point the HHS document was trying to make. The document states that a study “showed an increase in placental blood clotting in pregnant mothers who took the vaccine.” But the cited study looked at a subset of COVID-19 vaccine side effects and did not address placental blood clotting at all.

“Our study does not show an increase in placental blood clotting,” said Petousis-Harris, who was a co-author of the cited study. “This study did not even assess this outcome.”

The study also “did not find safety concerns warranting the removal of vaccine recommendations,” she said. Rather, the study concluded that “the findings support ongoing vaccine safety,” she added.

Male said that three studies did analyze 181 placentas of vaccinated people following delivery. “None of these found any evidence of placental pathology (which would include clotting) associated with COVID vaccination,” she said.

The HHS document also adopted the old anti-vaccine tactic of using context-free language in vaccine prescribing information to stoke fear about vaccines.

The document cited a line from the Pfizer and Moderna package inserts saying that available data on the vaccines “are insufficient to inform vaccine-associated risks in pregnancy.”

“It’s true that the safety and efficacy of mRNA

COVID vaccines in pregnancy has not been established by the manufacturers,” Male said. Pregnant people were excluded from the original clinical trials. But subsequent studies from scientists around the world show COVID-19 vaccines are safe and effective for pregnant people, Male added.

By contrast, package leaflets in the U.K. and Europe do include independent research findings, she said. These conclude that the available data have not shown an increased risk of miscarriage during the first trimester, although data from this trimester is “limited.” They also say that a “large amount” of data on women vaccinated later in pregnancy does not show “negative effects on the pregnancy or the newborn baby.”

Claims About COVID-19 Vaccines in Children Misuse and Omit Data

The document took a similar tack in justifying the change in COVID-19 vaccine recommendations for children, citing statements in prescribing information that safety and efficacy in children under age 12 “have not been established by manufacturers.”

Petousis-Harris said that such cherry-picking of regulatory language is a “common tactic used by people trying to discredit vaccines” and said the language “does not mean the vaccines are unsafe or ineffective.”

An opinion piece by the Vaccine Integrity Project staff and advisers explained that the prescribing information says this because the vaccines in children under 12 are still available under an emergency use authorization rather than full licensure. FDA documents supporting the EUA do have information on the shots’ safety and efficacy. The Vaccine Integrity Project is an initiative “dedicated to safeguarding vaccine use in the U.S.” and is led by volunteer public health and policy experts.

The Vaccine Integrity Project article additionally cited a large meta-analysis that found COVID-19 vaccination in children 5 to 11 years old was associated with reduced rates of infection and severe disease — and that severe side effects were rare.

The HHS document also followed a familiar pattern of exaggerating the risk of myocarditis following vaccination while leaving out key context.

Petousis-Harris said that there is a “known signal for myocarditis, particularly after the second mRNA dose in adolescent males.” However, this side effect is very rare and is “typically mild and self-resolving,” she said. 

And, as we have written before, myocarditis can occur following COVID-19 and is generally more severe after infection than after vaccination. Furthermore, “concerns about post-vaccination myocarditis are now largely in the rear-view mirror,” the Vaccine Integrity Project piece said. This side effect tended to occur in adolescent and young adult males getting a primary series of two COVID-19 vaccines close together. “Almost no one other than infants is receiving primary vaccine series doses anymore,” the authors wrote.

The HHS document leaves out this context.

One study in the HHS document — the one authored by researchers with a history of misleading on vaccination — misused safety monitoring data. The HHS document cited this study to claim that data from the Vaccine Adverse Events Reporting System showed that myocarditis reports in 2021 were “223 times higher than the average of all vaccines combined for the past 30 years.”

But as we have explained many times, the VAERS database cannot be used to compare vaccines and any sort of derived math from it is invalid. The early warning system collects reports of health problems following vaccination from anyone, regardless of whether the symptoms were caused by a vaccine. 

Because VAERS is largely voluntary, the number of reports is highly dependent on awareness. Given the scale and unprecedented nature of the COVID-19 vaccine rollout, along with increased reporting requirements at the time, there was a huge surge of reports to VAERS for the COVID-19 vaccines. But that by itself does not mean the vaccines are dangerous. In this case, VAERS successfully flagged myocarditis as a possible concern, which was then confirmed in other systems to be a rare side effect.

“The cited claim that ‘myocarditis reports were 223x higher’ ignores the lack of a denominator and the influence of reporting bias following media attention,” Petousis-Harris said.

The HHS document went on to claim that a preprint looking at COVID-19 vaccination in adolescents and children found that “cases of myo and pericarditis were found exclusively in those that received the COVID-19 vaccine.” But Petousis-Harris called this a “misreading” of the study, pointing out that other studies show myocarditis can occur in unvaccinated children after getting COVID-19.

The same study previously had been misused on social media to make the false claim that only vaccination — and not COVID-19 — causes myocarditis. At the time, an author of the study told USA Today that this was a misinterpretation, as the study compared vaccinated versus unvaccinated people and not vaccinated versus infected people.

Finally, the HHS document correctly described a study using a Japanese adverse events database, which found elevated rates of myocarditis after COVID-19 vaccination, particularly in younger males. Petousis-Harris said that the findings were in keeping with other global surveillance data on the vaccines and added that “the study does not argue against vaccination.”

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