With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy.
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.
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.
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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.
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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.
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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.”
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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.
