On May 20, 2025, Marty Makary, the new FDA Commissioner, and Vinay Prasad, the new head of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, published their framework for yearly Covid vaccines in an op-ed in the New England Journal of Medicine. The title of the article, “An Evidence-Based Approach to Covid-19 Vaccination,” suggested that decisions made by the FDA during this pandemic had not been based on “gold-standard evidence.”
Makary and Prasad argued that the government’s failure to produce good evidence had caused a loss of trust in vaccines. This new framework, they argued, would restore that trust, in part by: 1) limiting the vaccine to only those less than 65 who are in high-risk groups, and 2) requiring a prospective, placebo-controlled trial every year in otherwise healthy people 50 to 64 years of age.
Makary and Prasad are right to claim that “public trust in vaccination has declined.” But they are wrong about what caused it or how it can be restored. Loss of trust in vaccines occurred early in the Covid pandemic. In 2020, when the virus was killing hundreds of people a day — and vaccines, monoclonal antibodies and antiviral drugs weren’t available — the U.S. government closed businesses, shuttered schools, restricted travel and insisted on testing, masking and social distancing. Many Americans perceived these measures as massive government overreach.
The following year, 2021, when vaccines were available, people couldn’t visit their favorite bars or restaurants or sporting events or places of worship without proof of vaccination. Many who refused vaccines were fired from work. Again, this was seen as a heavy-handed government impinging on our freedoms. Makary and Prasad are now arguing that requiring placebo-controlled studies for yearly Covid vaccines will restore lost trust. In truth, that information is already available.
Studies consistently showed that mRNA Covid vaccines remained effective in preventing Covid in all age groups, independent of risk factors, for at least several months.
Retrospective studies of people who did or did not receive yearly Covid vaccines were performed in 2022 to 2023, 2023 to 2024, and 2024 to 2025. While retrospective studies aren’t perfect, these studies consistently showed that mRNA Covid vaccines remained effective in preventing Covid in all age groups, independent of risk factors, for at least several months. Regarding safety, the mRNA Covid vaccines have been administered to hundreds of millions of people. Arguably, no vaccine has been better studied. A study of more than 100 million people found that the vaccine is remarkably safe.
The small studies of healthy 50 to 64-year-olds proposed by Makary and Prasad will likely add little to nothing to what we already know about yearly Covid vaccines. Further, these studies are unethical. SARS-CoV-2 continues to circulate, causing thousands of hospitalizations and deaths every year. And, although healthy 50 to 64-year-olds are at low risk of hospitalization and death from Covid, they aren’t at no risk. How will Makary and Prasad respond if a few people in the placebo group suffered a serious or fatal Covid illness?
So, what are Makary and Prasad really talking about? Both men serve at the behest of Robert F. Kennedy Jr., an anti-vaccine activist who is interested in making vaccines less available, less affordable, and more feared. Both men share RFK Jr.’s conspiratorial beliefs that the federal government lied about vaccine safety issues, wrongly promoted the vaccine for people who didn’t need it, and behaved in a manner bordering on corruption. For example, Makary, a frequent guest on Laura Ingraham’s show on Fox, claimed that the federal government “covered up” information about myocarditis following Covid vaccination, when in fact this information was available within weeks of the vaccine’s release. “They buried it,” said Makary, “to protect the narrative.”
With RFK Jr. as head of HHS — and two sycophants from the FDA at his side — the anti-vaccine movement is influencing policy.
Like RFK Jr., who has said that Covid vaccines should be removed from the childhood immunization schedule, Vinay Prasad has said that “anyone who adds Covid vaccines to the childhood immunization schedule should be fired” and that “it is a useless vaccine for kids,” despite abundant evidence that Covid vaccines are effective and safe in children less than 5 years of age, and that more than 1,000 American children have died from this disease, about one-third of whom had no known risk factors. Further, Vinay Prasad has said that Peter Marks, his predecessor at CBER, was “either incompetent or corrupt.”
By limiting use of the Covid vaccine to only those less than 65 who are in high-risk groups, Makary and Prasad will make Covid vaccines less likely to be insured and, therefore, less available for young people who have legitimate reasons for receiving the vaccine. By requiring placebo-controlled trials before licensure, they will likely make Covid vaccines more expensive. And by insisting that both Pfizer and Moderna include a new, broader warning about myocarditis on their label, they will make the vaccine more feared. This new warning comes without the context that myocarditis following vaccination — in addition to being self-limited, transient, and generally benign — has virtually disappeared. Makary and Prasad are solving a problem that doesn’t exist.
For decades, anti-vaccine activists have been shouting their false claims about vaccine safety, cover-up, conspiracy and corruption from the sidelines. Now, with RFK Jr. as head of HHS — and two sycophants from the FDA at his side — the anti-vaccine movement is influencing policy. It’s a dangerous time to be a child in America.
Paul A. Offit, MD, is director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. This piece originally ran on his Substack, Beyond the Noise!
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