Yesterday, US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the firing of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP).
This independent group of experts makes recommendations to the CDC on the use of Food and Drug Administration (FDA)-approved vaccines to control vaccine-preventable diseases and protect our health.
It's important to note that ACIP recommendations adopted by the CDC director must be covered by applicable health plans and are therefore the link to affordable access to vaccines for most Americans.
Part of a troubling pattern
Kennedy's rationale, laid out in a Wall Street Journal opinion piece, was based on a series of inaccuracies, calling the ACIP "little more than a rubber stamp for any vaccine," and made accusations with little actual evidence, claiming it is "plagued by persistent conflicts of interest."
The only 'proof' Kennedy offered on conflicts of interest were oversight reports on investigated activities from at least 18 years ago.
In reality, ACIP frequently makes adjustments to vaccine recommendations based on its regular review of new safety, efficacy, and epidemiologic data. And federal advisory committees are required to deliberate in a public forum for all to see.
As standard protocol, members must declare conflicts at the start of every meeting and must recuse themselves from matters in which a conflict could influence their actions. The only "proof" Kennedy offered on conflicts of interest were oversight reports on investigated activities from at least 18 years ago.
Yesterday's announcement follows a pattern for Kennedy and the agency that he oversees: With no transparency, the little evidence provided in support of policy changes is selective, and data are retrofitted to support decisions that dovetail with Kennedy’s personal views.
For example, on May 27, in a radical departure from vaccine recommendation protocol (ie, consideration of the advice of independent experts who publicly present the newest scientific evidence), Kennedy rescinded COVID-19 vaccine recommendations for children and pregnant women without providing data to support the change.
More recently, HHS has given a document to Congressional committees to justify the change—the first glimpse of how Kennedy's decision was rendered.
Unfortunately, once again, politics and ideology appear to have shaped the document.
Titled "COVID Recommendation FAQ," it alternates between flat-out falsehoods and misleading claims from fewer than a dozen references.
Similar to the MAHA [Make America Healthy Again] report, we see the inclusion of footnotes to support the appearance of a well-researched, evidence-based document.
Then you dig into the references, by topic:
COVID-19 Vaccination in Pregnancy
For example, the FAQ document claims, "A number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy."
The studies it cites say the opposite.
The first study, published in in 2023 in BJOG, An International Journal of Obstetrics and Gynecology, provides data from nearly a quarter of a million pregnant women, over a third of whom were vaccinated.
The study concludes, "This population-based cohort study observed no relation between first SARS-CoV-2 vaccination and miscarriage, specifically while accounting for the competing risk of induced abortion. This study reiterates the importance of including pregnant women in new vaccine clinical trials and registries, and the rapid dissemination of vaccine safety data."
The second study, published in Obstetrics and Gynecology in 2022, says, "Administration of COVID-19 mRNA vaccines was not associated with an adverse effect on stimulation or early pregnancy outcomes after IVF [in vitro fertilization]. Our findings contribute to the growing body of evidence regarding the safety of COVID-19 vaccination in women who are trying to conceive."
The FAQ also claims that a study shows "statistically significant increases in preterm birth." But the study, published in BMC Pregnancy and Childbirth, which included more than 2,300 women vaccinated during pregnancy (and more than 3,300 who were not), actually says, "SARS-CoV-2 vaccine appears to be safe during pregnancy with no increase in incidence of preterm labor and small for gestational age compared to unvaccinated women."
The study does indicate that there may be an increased risk of preterm birth for women who receive the vaccine in the second trimester but also cautions that "Unmeasured confounding may have contributed to the results."
The final alleged data point in the FAQ—alleging that COVID-19 vaccines cause "an increase in placental blood clotting in pregnant mothers"—isn't even discussed in the cited study.
We know that informed decisions are based on an assessment of pros and cons. Missing from the FAQ citations are the key reasons pregnant women (and their risk of severe disease from COVID-19 infection) were prioritized for vaccination in the first place.
For example, this meta-analysis, which was not cited in the FAQ document, included 435 studies of pregnant and non-pregnant women. Among more than 2 million women, there was over a two-fold and statistically significant increase in both intensive care unit admission or need for mechanical ventilation in women who were pregnant or recently pregnant.
Providing further support for vaccination, the paper concludes, "Pregnant women with COVID-19 [infection] versus without COVID-19 are more likely to deliver preterm and have an increased risk of maternal death and of being admitted to the intensive care unit. Their babies are more likely to be admitted to the neonatal intensive care unit."
Vaccination in the Pediatric Population
In contrast to the inaccuracies offered to support pregnancy recommendations, the justification for the change for pediatric vaccination relies on longstanding, misleading, and questionable claims that have been circulated in anti-vaccine circles for years, including bogus claims about the prevalence of myocarditis and issues with the vaccine approval process.
The first citations in the FAQ point to the package inserts for the Moderna and Pfizer vaccines, which state that safety and efficacy in children younger than 12 years "have not been established." This language is required by law because the vaccines have not yet met the requirements for licensure, but their safety and efficacy were established for authorization under Emergency Use Authorization for use during the pandemic.
And you can read about the studies that support the vaccines' use in children on the FDA website here and here. Of note, had the safety and efficacy been 'established,' these vaccines would have been approved rather than authorized, and their delay to reach these populations would have been measured in months to years.
Meanwhile, the FAQ ignores the information on the FDA website and the reams of data that demonstrate the safety and efficacy of the COVID-19 vaccines, like this meta-analysis, published in JAMA in 2023, involving more than 10.9 million children aged 5 to 11 years.
The Question of Myocarditis
The FAQ overstates the prevalence of and current concerns related to myocarditis. It quotes statistics from the previously cited study about myocarditis reports, noting they were "223 times higher than the average of all vaccines combined for the past 30 years—representing a 2,500% increase." Of course, an increase in reports would be expected in the context of more than 700 million COVID-19 vaccine doses given.
In fact, the COVID-19 vaccination effort easily dwarfs 30 years of vaccinations, with more than 241 million people in the United States receiving at least one dose by the end of 2021. At the height of the COVID-19 pandemic, the country was averaging 4 million doses per day. Reports to the Vaccine Adverse Event Reporting System (VAERS) during this period should, by definition, far exceed reports during any previous period.
Concerns about post-vaccination myocarditis are now largely in the rear-view mirror.
While vaccination, "compared with placebo, was associated with higher incidences of adverse events, the overall frequency of severe adverse events, including myocarditis, was low." The paper concludes, "These data support the safety and efficacy of mRNA COVID-19 vaccines among children aged 5 to 11 years and endorse the universal age-based recommendations."
The FAQ also cites a 2024 piece about the risk of myocarditis following COVID-19 vaccination but fails to mention that "the Editor and the publisher were alerted to potential issues with the research methodology and conclusions and author conflicts of interest… and an investigation is underway."
And studies like this one have repeatedly found that the risk of myocarditis to the general population from COVID-19 infection is much higher than that from vaccination. In fact, myocarditis risk for young men after vaccination is well-known to be rare and was of the greatest concern after the second dose of the primary series when the doses were spaced close together.
Even in that setting, the condition is generally mild, with cases typically cases resolving with anti-inflammatory medicines like non-steroidal anti-inflammatory drugs (NSAIDS), according to this study published in JAMA. In the largest known study of post-vaccine myocarditis outcomes from France, no deaths and no heart transplants were reported; these patients generally had better outcomes than those with post-COVID myocarditis.
ACIP began talking about myocarditis in June 2021. In in February 2022, concerns led federal health authorities to recommend increasing the interval between the first and second doses of the primary vaccine series for men aged 12 to 39 from 3 to 4 weeks to 8 weeks. In addition to this adjustment, concerns about post-vaccination myocarditis are now largely in the rear-view mirror. Almost no one other than infants is receiving primary vaccine series doses anymore.
Where Do We Go from Here?
Risk-benefit analyses can, of course, evolve with the availability of new data to inform a policy. Until now, Americans have counted on independent experts to make recommendations after public, fact-based deliberations. Based on what we have all now witnessed, we can no longer rely on our government to do that.
Kennedy's actions since his confirmation underscore the urgent need for those who care about protecting lives from vaccine-preventable diseases to come together now to create an alternative process to maintain vaccine access and ensure that vaccine recommendations are evidence-based and not driven by one individual's personal ideology.
Instead, Kennedy is substituting his own uninformed judgment. He is willing to jettison the open, deliberative process we have used to maintain Americans' access to vaccines that help keep our communities safe and keep us out of the hospital. And he is showing little regard for evidence, independent expertise, or transparency.
Kennedy's actions since his confirmation underscore the urgent need for those who care about protecting lives from vaccine-preventable diseases to come together now to create an alternative process to maintain vaccine access and ensure that vaccine recommendations are evidence-based and not driven by one individual's personal ideology. The Vaccine Integrity Project is fully committed to advancing this effort.
Vaccine Integrity Project Viewpoints are authored by project staff and advisers. They are intended to address timely issues regarding vaccines with straight talk and clarity by presenting facts to counter falsehoods.