On Tuesday, the Food and Drug Administration announced plans to significantly curtail people’s access to Covid-19 vaccines. Under the new framework, outlined in an article published in the New England Journal of Medicine by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad, routine approval of updated vaccines will be limited to the elderly and vulnerable only. Approval for the rest of the “healthy” population will require extensive, costly testing.
America’s right wing has been getting solid mileage for years now out of politicizing all things Covid.
While Makary and Prasad claimed their policy “balances the need for evidence,” critics noted a number of problems with the plan right away. Some of the research demanded for broad approval of new Covid vaccines was infeasible and even unethical. There were no carve-outs for caregivers upon whom vulnerable people depend. The timing of the release appeared primed to usurp the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which makes vaccine recommendations.
Valid as the criticisms were, the new approach to the Covid vaccines most likely has little to do with practical public health management. Instead, it appears to be an inevitable effort to reinforce narratives favored by the Trump administration and the political right.
While it may seem unusual that Donald Trump’s FDA would go after vaccines developed through his Operation Warp Speed program in his first term — vaccines he once called the “gold standard” — America’s right wing has been getting solid mileage for years now out of politicizing all things Covid.
It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ending a politically and economically inconvenient crisis. Over time, however, the campaign expanded to include more wedges — the virus’ origins, school closures, mask mandates and, of course, vaccines.
After the emergency declaration ended and the public moved on — with a U.S. Covid death toll standing at well over 1 million — right-wing groups, politicians and media pivoted to rewriting pandemic history.
The success of those efforts may have contributed to Trump’s return to office after mismanaging the crisis during his first term. The president himself seems to think so. Last month, the White House replaced the informational covid.gov website with a new page promoting the speculative lab leak theory of the pandemic’s origins and featuring sections on the harms of lockdowns and mask mandates.
The FDA’s new guidance on Covid vaccines can be seen as an extension of this effort, using the imprimatur of the agency to validate misleading and false narratives promoted by the right about the Covid — namely that the vaccines are insufficiently tested with unknown effects and unsuited for young people. Indeed, the authors of the policy were themselves prolific spreaders of those narratives.
With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy.
Makary was already a bestselling author before Covid, and his vocal criticisms of the federal pandemic response and his questioning of the mRNA jabs built up his audience and political influence. The doctor became a favorite of media outlets like Fox News and dark money groups like the anti-vax Brownstone Institute and the Heritage Foundation — which produced the Trump 2.0 blueprint, “Project 2025.” Makary got to testify before the GOP-led House Select Subcommittee on the Coronavirus Pandemic at its first hearing in February 2023 and participate in the wellness roundtable Sen. Ron Johnson, R-Wis., convened in September. During his testimony before Congress, Makary called the decision to offer booster doses to children a “tragic mistake.” He also falsely indicated that no healthy children had died from Covid in the United States to argue the jabs presented a greater risk than the virus to that young population.
The FDA commissioner role was the big prize, however. Serving under his ally, Health and Human Services Secretary Robert Kennedy Jr. — a longtime anti-vaccine activist who called the Covid jab “the deadliest ever made” — Makary was bound to take a stab at the vaccines.
All of the signs were there. One of his first acts was to bring on another vaccine skeptic, Dr. Tracy Beth Høeg, a physical medicine doctor and epidemiologist who had worked in Florida Gov. Ron DeSantis’ Health Department, as his special assistant. The pair had collaborated on a Brownstone project called the Norfolk Group, which crafted an outline for a congressional inquiry into the federal Covid response ahead of the subcommittee hearing. With Høeg on the team, Makary’s FDA held up the scheduled approval of the Novavax booster, eventually scaling it back and limiting it to the elderly and the vulnerable in a precursor to Tuesday’s policy announcement.
Earlier this month, Makary also brought Prasad into the agency as its top vaccine regulator. Prasad, like Makary, has a link to Brownstone and spent years criticizing the FDA over Covid jabs, hyping up safety concerns about rare side effects like myocarditis, questioning their efficacy and suggesting that the risk-benefit ratio disfavored approval.
Prasad has become known for his aggressive posture, extreme statements and demands for randomized-controlled trials for all Covid mitigations, including new boosters. Although in his academic research, he has praised the vaccines — a paper he co-authored in June called them “a miraculous, life-saving advance offering staggering efficacy in adults” — his demeanor online betrays his position. Prasad has argued that mRNA research ought to be deprioritized by the National Institutes of Health, and in March, he posted on X mocking the drop in Moderna’s stock price over the previous year, writing, “MRNA technology is so promising and everyone wants it!! 🥳.” His advocacy brought him a massive online following and also paid off politically. In 2022, the pair were two of the loudest voices lambasting the FDA for allegedly approving the bivalent omicron-specific boosters without adequate testing behind them. In a post on Twitter — now X — that October, Makary lamented, “It appears the FDA no longer requires clinical trial data Pfizer & Moderna’s new Omicron vax (tested in 8 mice) was authorized today for children, who are at the highest risk of vaccine-induced myocarditis.” “FDA bypassed their expert advisers…The most political FDA & CDC in U.S. history,” he wrote. Is this new guidance the start of a complete phase-out of the vaccines, and might other immunizations follow? As The Wall Street Journal noted the previous month in an infographic, the bivalent doses did not need to undergo human testing for safety since the original omicron strain vaccines did. “The changes simply update proven shots,” the graphic explained. “The process is similar to the development of the annual flu shots, which are given without testing them in people.” Days after the Journal piece, Prasad — who at the time claimed to be a political “liberal” in the vein of Elizabeth Warren and Bernie Sanders — argued in a YouTube video, as he wrote in the tweet sharing it, “a bivalent covid booster is NOT LIKE the annual flu shot and…human studies (not 8-10 mice) are needed.” Prasad’s post was later boosted by Dr. Jay Bhattacharya, today the director of the National Institutes of Health. Another of his tweets was shared by Makary. Billions of doses have been given over the years. There has been extensive safety monitoring of the vaccines, which have saved millions of lives in the United States and prevented even more hospitalizations. The data shows they reduce Covid transmission and the odds of getting long Covid and offer robust protection against severe illness and death. With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy. The only question is how far the agency will go. Is this new guidance the start of a complete phase-out of the vaccines, and might other immunizations follow? Time will tell.
Walker Bragman
Walker Bragman is a New York-based investigative journalist and founder of the not-for-profit Accountability Journalism Institute. 
