Much of the federal government’s response to the raging COVID-19 pandemic in 2020 was admirable. The government-funded Operation Warp Speed project to develop and test vaccines rapidly and the FDA making them available under Experimental Use Authorizations were extraordinary achievements. Millions of lives were saved, and untold numbers of cases of lingering disability from “long COVID” were prevented. The impact of the pandemic has diminished, but COVID is still with us. Since October of last year, an estimated 30,000 to 50,000 people have died from the virus and between 260,000 and 430,000 have been hospitalized, according to data from the CDC.
In the wake of the global devastation wrought by the pandemic, public trust in science, medicine, and some government institutions has faced unprecedented challenges. Recent pronouncements by government officials — masquerading as a thoughtful recalibration of public health strategy — risk undermining that trust even further with flawed policies.
Promoted with feel-good buzzwords like "evidence-based policy” and “gold standard science,” the just-announced FDA regulatory framework for COVID vaccines instead reflects a dangerous convergence of scientific revisionism, anti-vaccine sentiment, and sleight-of-hand. Focused on revising the United States’ previous, nearly universal COVID vaccination strategy, it substitutes a narrower, "targeted" model for booster access that runs counter to the available evidence. It resembles the widely criticized approach to vaccination promoted by NIH Director Dr. Jay Bhattacharya and the deeply flawed Great Barrington Declaration.
This new policy, announced by FDA Commissioner Dr. Marty Makary and the Agency’s head vaccine regulator Dr. Vinay Prasad in a recent article in the New England Journal of Medicine and during a Town Hall meeting, critiques the U.S. as overly aggressive in its pursuit of COVID booster access. It lauds European models for restricting booster recommendations to older and high-risk populations, and portrays the previous U.S. model as blunt, unsophisticated, even paternalistic.
Although it is true that the urgency for universal vaccination has waned, the authors’ framing is not only misleading but reflects a misunderstanding of vaccine testing and the social obligations of public health. This last point is especially pertinent, because it is unclear how much vaccinating healthy people under age 65 will reduce the risk of spread -- a social obligation -- while not vaccinating will certainly lead to many of them becoming infected. In their NEJM article, Makary and Prasad observe that “natural immunity from Covid-19 against severe disease appears robust,” ignoring both that reinfection with SARS-CoV-2 is not uncommon and that natural immunity derives from an active infection -- with the attendant risk of severe illness, long COVID, hospitalization, and death.
At its core, the new policy advances the idea that the benefits of COVID boosters are "uncertain" in healthy individuals under 65 years of age, especially those who have had prior infection or received multiple prior doses of vaccine. This is a classic case of selective skepticism — demanding impossible certainty for public health interventions while turning a blind eye to the well-documented risks of the SARS-CoV-2 virus, including long COVID, viral mutation/evolution, and unpredictable disease severity.
Misrepresenting Vaccine Efficacy
The argument hinges on a false dilemma: that unless COVID vaccines can unequivocally be shown to prevent severe outcomes in lower-risk groups through randomized controlled trials (RCTs), we should withhold approval or recommendations for them to be vaccinated. This standard is not applied to most other vaccines, nor is it practical or ethical during a pandemic that, although much diminished, could reemerge with the appearance of new variants.
The revised statistical bar set by the FDA ignores the overwhelming amount of real-world data showing that booster shots reduce the incidence of severe illness, hospitalizations, and deaths across age groups, particularly after the emergence of new viral “variants of concern.” (The first round of vaccines also reduced significantly the incidence of infection and transmission by the original Wuhan strain of SARS-CoV-2, but as new variants arose, subsequent vaccines were effective only at reducing severe illness, hospitalizations, and deaths.)
Moreover, the Makary-Prasad policy, which accepts antibody titers as an approval criterion for high-risk groups but demands randomized controlled trials with demonstrated improvement in actual clinical outcomes for healthy populations, creates a bifurcated system that serves neither scientific rigor nor public health equity. It is an inconsistent framework masquerading as a principled compromise. For vaccines as safe as the COVID vaccines have proven to be over five years, this policy makes no sense.
Immunogenicity is an accepted proxy for efficacy for new versions of vaccines that differ little from previous ones (analogous to new annual versions of seasonal flu vaccines) in fast-evolving outbreaks of viral infections. The imposition of a different standard for younger, healthy individuals is both scientifically unjustified and likely to be harmful.
The Dangerous Consequences of Vaccine Hesitancy
The authors cite low booster uptake rates in the U.S. as evidence that public health messaging has failed or that the need for boosters is itself questionable. But low uptake is not a signal that vaccines lack value; rather, it reflects the consequences of politicized misinformation, eroded institutional trust, and fractured public health leadership — phenomena these authors and some of their government colleagues have helped to fuel.
The drop in MMR uptake has not resulted from public health officials having pushed too hard on COVID vaccines but is more likely due to coordinated disinformation campaigns — amplified by high-profile skeptics and contrarians, some of whom are now in senior positions in the U.S. government — that have sowed doubt about all vaccines. The suggestion that scaling back COVID vaccination efforts would restore trust in traditional vaccination is, I believe, both dangerous and disingenuous.
Undermining Regulatory Standards Under a Veneer of Rigor
At first glance, the FDA’s new policy – which would allow immunogenicity endpoints for high-risk groups, while calling for randomized controlled trials for those at lower risk -- might seem like a measured approach, but it is not.
Even the trial design newly required by the FDA — a placebo-controlled trial in lower-risk people who have already had COVID-19 and have received multiple prior vaccines — appears to be intended not to generate meaningful data but rather to stall the vaccine pipeline and stoke doubt under the pretext of scientific neutrality.
That last point deserves emphasis. The “preferred primary end point” in the required clinical trials will be symptomatic COVID infection -- although not since the first round of COVID vaccines produced in 2020 in response to the original Wuhan variant of SARS-CoV-2 has the vaccine significantly prevented infection. As noted above, the vaccines have, however, continued to be effective at preventing serious illness, hospitalization, and death – equally important outcomes.
Furthermore, the FDA now specifies that people who have had COVID in the past year should not be excluded from the clinical trials — supposedly because “evidence is needed for the average American” -- and that follow-up should extend for a minimum of 6 months to ensure that early booster gains persist.
Those parameters are unrealistic. They ensure that except during a surge with high levels of infection in the community, performing the trials and their evaluation by regulators would take too long to acquire statistical evidence of efficacy and get the vaccines to the population that needs them.
In the absence of those trials, the vaccines’ labeling will specify approval for only a small fraction of the U.S. population under the age of 65 – the anti-vaxxers’ dream scenario.
This FDA policy shift is not about rigor; it appears to be more about capitulation to political pressure and contrarian ideology.
The Makary-Prasad statement deserves some exploration of the context of the formalities of regulatory policy-making. This important shift in policy appears to have been made without consultation with the FDA’s Vaccines and Related Biological Products Advisory Committee, which met on May 22nd, days after the Makary-Prasad article and the Town Hall meeting. (Neither Makary nor Prasad is a vaccine expert, so one must wonder where this policy originated. The public has a right to know.)
Moreover, there appears to have been no guidance document on the policy published by the FDA. A very smart ex-government attorney said about the process of promulgating this policy, “excluding vaccine experts and expert committees is FDA malpractice.” (Personal communication.)
The Real Lessons of the Pandemic
The COVID pandemic has taught us many painful lessons, among them the importance of acting decisively with the tools of modern science and being transparent with the public about what we know and don’t know. Vaccines remain the single most effective intervention to reduce not only deaths and hospitalizations, but also societal disruption, economic loss, and long-term disability. Public health recommendations must, of course, adapt with the emergence of new data — but they should do so anchored in evidence, not dictated by ideological opportunism.
Rather than withdrawing protection from lower-risk populations, we should be doubling down on clear communication, widespread accessible vaccination, and proactive surveillance. If all else fails during surges of COVID cases, however, vaccine mandates are a legitimate and effective option.
Conclusion: Science Must Not Be Co-opted
The FDA’s pivot — applauded by critics of universal vaccination — legitimizes fringe views that have already done profound damage to public trust.
The science and medicine communities are not surprised. Makary and Prasad, themselves seemingly lukewarm about vaccines, are surrounded by ardent anti-vaxxers. Makary’s boss, Health and Human Services Secretary Robert F. Kennedy, Jr., has claimed that no vaccine is safe and effective, and then has repeatedly denied having said it. Sports medicine physician Tracy Beth Høeg, FDA Commissioner Makary’s Special Assistant, rose to prominence by challenging school closures, mask mandates, and the regulatory approval of booster shots for children.
As immunologist and microbiologist Dr. Andrea Love tweeted on May 21st: “Guess we weren’t being hyperbolic when we said the MAHA crew was going to target vaccines. Were we?”
Science and regulation must evolve, but they must do so with integrity, not under the influence of those who mistake contrarianism for courage.
Henry I. Miller, MS, MD
Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.
