Critic of Covid boosters set to enact tough agenda as top US vaccines official

Vinay Prasad, an oncologist and hematologist who has called for more regulatory scrutiny of pharmaceuticals, including Covid vaccines, was named the top US vaccines official earlier this month.

Marty Makary, commissioner of the US Food and Drug Administration (FDA), announced in a 6 May email obtained by the Guardian that Prasad would now lead the Center for Biologics Evaluation and Research (CBER), which oversees biological products like blood, vaccines, and cellular and gene therapies. Biotech stocks plunged at the news.

Prasad has signaled, in blogposts, podcast episodes and social media posts, that he is likely to enact tougher regulatory scrutiny for new therapies, especially when it comes to the rapid approval of new medications.

He has also repeatedly decried Covid boosters and called for extensive studies to see whether grouping childhood vaccines together causes autism, which multiple studies have debunked.

Since 2020, Prasad has been a professor of epidemiology and biostatistics and medicine at the University of California, San Francisco, and he sees patients at San Francisco general hospital.

He is licensed as a physician, but he is no longer board-certified in internal medicine, hematology, or oncology – which means he’s unlikely to continue practicing clinical medicine, said David Gorski, a professor of surgery and oncology at Wayne State University.

“There are a lot of doctors who, when they transition to a non-clinical position, let their board certifications lapse because it’s expensive and a lot of work to keep them up – but it’s unusual for someone that young,” Gorski said.

Prasad will oversee more than 1,000 employees at the CBER, but does not seem to have held previous leadership positions beyond his research lab. He did not respond to the Guardian’s interview request.

An analysis of Prasad’s public statements reveals an outspoken critic of the pharmaceutical industry – and of his peers in public health.

Prasad has called out the practice of pharmaceutical companies offering payments to doctors. He has strongly advocated for limitations on the relationships between pharmaceutical companies and regulators, arguing that regulators with recent pharma work, such as running clinical trials, should be removed, and recommending that regulators should not have consulted for pharma for five years before joining the FDA.

Prasad has also proposed making randomized trials less bureaucratic and thus less expensive. He has long pushed for stronger regulations around the approval of new medications, especially for cancer and for rare conditions such as Duchenne muscular dystrophy.

In the accelerated approval process, regulators “didn’t follow up on these trials to make sure that the post-marketing licensure trials lined up with the results that led to the accelerated provisional approval,” Gorksi said – a practice that Prasad sharply criticized, and a stance with which others including Gorski agreed.

But in 2021, he had a “heel turn” and began strenuously opposing Covid boosters and other precautions, like wearing face masks, as well, Gorski said. Prasad started questioning “how dangerous Covid actually was”, he said.

Prasad has frequently advocated for removing the Covid vaccine from the US childhood immunization schedule, and that it was “malpractice” for doctors to recommend the booster for children.

Prasad said it was “only a matter of time” before a serious safety signal emerges from the vaccines, which have been administered to millions of people around the globe, and called annual update boosters “a game of Russian roulette” in a blogpost.

He believes the risk of myocarditis and other side effects from mRNA Covid shots outweigh the benefits of preventing illness and death. Myocarditis is a markedly more common side effect from Covid infection, which also remains a top cause of death.

“Dr Vinay Prasad spent the past four years spreading misinformation on Covid and the Covid vaccine,” said Jonathan Howard, an associate professor of neurology and psychiatry at NYU Langone Health and author of the book We Want Them Infected.

Prasad recently called for a clinical trial, separated by age, to assess the effectiveness of each updated Covid shot. The vaccine would only be authorized “if it works”, Prasad wrote – but he believed it won’t: “I suspect the trials may only be positive in the above 80 and nursing home group. The rest will be negative.”

Holding new trials for updated vaccines is unusual. It’s a lengthy process that means vaccines would likely not be available before the fall, when updated boosters have been rolled out in the past.

This approach would also throw flu vaccines into uncertainty. “It’s time to reform the flu vaccine process for the 21st century,” Prasad wrote in March.

Gorski doubts “that there will be an updated Covid vaccine” and doesn’t “think this will be an issue with the flu vaccines right away, but I think we’re moving that way”.

Covid (and flu) shots are still greatly needed, Gorski said, as “the virus keeps mutating and evolving to evade pre-existing immunity. It still kills a lot of people.”

Prasas has repeated several anti-vaccine talking points, including the call for more studies on the effects of clustering childhood immunizations together; a greater focus on saline placebo trials; and revamping the current system to allow more lawsuits against vaccine makers.

By criticizing how clinical trials are done, skeptics such as Prasad “cast doubt on the current evidence by implying that whatever you’re criticizing has never been adequately studied and probably doesn’t work”, Gorski said.

Prasad has also regularly mocked scientists and doctors for wearing masks, and he called the public health workforce “the dumbest people in the country” and “dummies talking out their ass” because they are willing to accept low wages for their work.

He has repeatedly criticized Peter Marks, the person who last held this job and who says he was pushed out by health secretary Robert F Kennedy Jr, calling Marks “dangerous”. Prasad has also called out other officials previously at the helm of health agencies, including Mandy Cohen, Rochelle Walensky and Robert Califf.

“In my opinion, these pieces of shit are still lying,” Prasad said of public health leaders on a podcast interview.

“Using vulgar, unprofessional language, Dr Prasad excoriated the previous medical establishment for not doing randomized-controlled trials for every variant and demographic. That’s his job now, and we can hold him to the same standards,” Howard said.

Gorski agreed: “He is now the medical-proof establishment. Prasad owns it now when it comes to vaccines – he owns it all.”