> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Hoeg, Prasad Draw Vaccine Concerns - URL: https://www.fdaweb.com/hoeg-prasad-draw-vaccine-concerns/ - Published: 2026-01-06T12:00:00.000Z - Updated: 2026-09-14T15:30:00.000Z - Author: David McFarland - Tags: Biologics, #legacy-id-D5160427 Mainstream media stories at the end of 2025 focused on the ongoing controversy over vaccines brought about by recommendations from CBER director **Vinay Prasad** and newly-appointed CDER director (the fifth director in 2025) **Tracy Beth Hoeg**. The *Guardian* [reports](https://www.theguardian.com/us-news/2025/dec/31/tracy-beth-hoeg-fda-vaccines?ref=fdaweb.com) that Hoeg’s appointment “could signify a closer partnership between the drug and vaccine Centers as Høeg and Prasad consolidate power at the agency — and it signals a greater focus upon dismantling already approved vaccines at FDA.” Her appointment is criticized in the article by neurologist and psychiatrist **Jonathan Howard**, who is described as someone who has closely tracked Covid contrarians. “She doesn’t seem to have any of the qualifications” for running CDER, Howard told the newspaper. “She’s never run a randomized clinical trial. She has no expertise leading a large organization. She has no expertise in industry regulation or drug approvals.” Former CDER director and FDA acting commissioner **Janet Woodcock** told the newspaper that CDER directors would typically “understand laws and regulations and the science of drug development. Objectively, she doesn’t have the kind of background that previous people who ran CDER have had.” Woodcock also pointed to the breadth of CDER’s remit, with its focus not just on new drugs but also generic drugs, biosimilars, and over-the-counter products. “The thing you don’t keep your eye on, that’s the thing I always told people is going to bite you in the behind,” Woodcock said. “It’s a huge management job (more than 5,000 employees) if you do it right.” Asked about Høeg’s qualifications, HHS press secretary **Emily Hilliard** said the “questions rely on incorrect assumptions. This background aligns with the responsibilities of her role,” noting that Høeg had been an advisor to FDA commissioner **Marty Makary** on “drug safety and regulatory science, including computational safety modeling and vaccine surveillance.” Commenting on Høeg’s stated approach to vaccines, Howard said she is “an all-around ideologue who starts off with her conclusions and works backwards to retrofit the evidence in a very disingenuous, dishonest way…. They’re totally consolidating power, these Covid contrarians. Everything that’s happening now is a direct consequence of rage and anger over Covid mitigations. These people are furious, livid that their genius wasn’t acknowledged. So they’re on kind of a revenge tour.” Meanwhile, a *KFF Health News* [article](https://www.phillyvoice.com/fda-vaccine-policy-changes-rfk-prasad/?ref=fdaweb.com) covers the opposition of 12 former agency commissioners to a Prasad internal email claiming that Covid-19 vaccines had caused the deaths of at least 10 children. They wrote in the *New England Journal of Medicine* that Prasad’s claims and proposed policy changes pose “a threat to evidence-based vaccine policy and public health security” and break sharply from long-standing scientific norms. The news service says that what is unfolding inside FDA is not a narrow dispute over Covid vaccines. Rather, according to critics and vaccine scientists, it is an effort to rewrite the rules governing the entire U.S. vaccine system — how risks are weighed, how benefits are proven, and how quickly lifesaving shots reach the public. The piece says former agency leaders warn that the changes could lead to fewer vaccines, slower updates, weakened public trust, and more preventable outbreaks. The article says Prasad has said FDA should stop relying on immune markers to establish vaccine efficacy and instead should require placebo-controlled randomized trials that track hospitalizations and deaths before approving most new vaccines. The news service says many immunologists and vaccine experts say it is unethical to test vaccines known to be effective against disease with a control group that would receive a placebo, exposing them to infection. The former FDA commissioners said that Prasad was exploiting public frustration over the federal response to Covid to spark doubt about the entire childhood vaccine system, which could wipe out decades of success in protecting children from deadly diseases. “This is really different. And it’s really dangerous,” former. commissioner **Robert Califf** told KFF Health News. “And people will be hurt, particularly by the vaccine decisions. He said the goal of HHS secretary **Robert F. Kennedy Jr.** seems to be to make it impossible for vaccines to be available in the U.S., warning that if Prasad’s proposals advance, “it won’t be a viable business.” Hilliard pushed back, saying, “The American people deserve evidence-based science. Prasad’s email lays out a philosophical framework that points us toward that higher standard. We will soon release documents laying out that framework and data outlining how the Covid vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”