FDA's big change to how vaccines will get approved
We obtained an internal email laying out the planned shift in strategy.
Breaking news: a top Trump health official privately laid out a plan to transform how vaccines are approved in America.
Vinay Prasad, who oversees vaccine safety at the Food and Drug Administration, told colleagues on Friday that his team had identified a link between covid-19 vaccines and “at least” 10 children’s deaths, per an email we obtained at The Washington Post.1
Based on that claim, Prasad said that FDA would adopt a new “path forward” when approving all vaccines.
That new approach will include:
changes to annual flu shots
changes to vaccine labeling
new requirements for randomized trials
Here’s an excerpt from Prasad’s nearly 2,400-word email to colleagues at FDA’s Center for Biologics Evaluation and Research, this part for health-policy wonks:
Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine. This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints (any prior promises will be null and void), and we will demand pre-market randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers. Immunogenicity will no longer be used to expand indicated populations-- these populations should be included in premarket RCTs.
To translate, for everyone else: Prasad wants drug companies to do a lot more to prove that their vaccines are safe, including when they want to expand an existing vaccine to a new population.
More evidence always sounds like a good idea, especially in matters of public health.
But as current and former FDA staff and public-health experts told me and my colleague Rachel Roubein, agency officials already have considerable data when weighing vaccine approvals.
“It’s not like these things are being approved without strong scientific evidence,” said Jesse Goodman, who held the same job as Prasad in the George W. Bush administration. “They’re being approved with strong scientific evidence.”
“Asking for more evidence” is also a strategy of Robert F. Kennedy Jr., the nation’s health secretary and a long-time anti-vaccine advocate, who’s supported Prasad’s agenda.2
In this case, Prasad’s demands for more evidence will likely add years to many vaccines’ approval process, current and former FDA officials told us. It could also keep new vaccines off the market by creating significant barriers.
And speaking of evidence: many public health experts have questions about Prasad’s claim that coronavirus vaccines are linked to children’s deaths.
In his email, Prasad acknowledged that the link was identified after reviewing reports submitted to the federal Vaccine Adverse Event Reporting System, or VAERS. That database contains unverified reports of side effects or bad experiences of vaccines submitted by anyone, and federal officials have emphasized that VAERS alone is not designed to assess whether a shot caused a death.
Peter Hotez, the director of the Center for Vaccine Development at Texas Children’s Hospital, said he wanted to see if Prasad’s claims about coronavirus vaccines could be supported with more data as well as information about any underlying health conditions.
“Also given the public health implications, this is not something one casually blurts out in an email,” Hotez wrote in a text message Friday night.
More details in our story, available here with a gift link (no paywall):
FDA to impose strict new vaccine requirements, claiming child covid shot deaths
Speaking of Kennedy: I joined “Washington Week with The Atlantic” on Friday night to discuss his controversial tenure as the nation’s top health official.
Michael Scherer, the author of a sweeping Atlantic cover story on Kennedy, and Julie Rovner, a KFF Health News reporter and de facto dean of the Washington health-policy press corps, rounded out the panel with host Jeff Goldberg. The show was recorded before the news of Prasad’s vaccine plan, but we still had tons to talk about — how Kennedy came to his beliefs, his pressure on the health agencies and much more.
It was my first time doing an in-person TV roundtable since pre-pandemic. (That’s mostly a function of having young kids — who both arrived since 2022 — and the resulting squeeze on my schedule. Doing Zoom hits from my kitchen table is a lot easier than heading to a studio!) And if you’ve ever had the experience, you know there’s a big difference between sitting at home, staring into your laptop, and being on set, as activity buzzes around you, and you try not to have a brain freeze on live television.
We spent some of the time talking about my recent scoop with Rachel about another FDA official, Richard Pazdur, and his own private worries about the Trump administration’s agenda.
Pazdur, the nation’s top drug regulator, has told colleagues that he’s worried that political considerations are leading FDA to cut corners, according to people who spoke with us. He singled out a new Trump and Kennedy-backed program to dramatically speed up pharma companies’ drug approvals if they agree to cut their drug prices like Trump wants, warning that the effective quid pro quo could be illegal and pose a risk to public health.
The Prasad and Pazdur stories are also reminders: a small group of leaders is making big decisions that could affect all of our health. We’re trying our best to cover those developments — and break as many of those stories — at The Post.
This claim about coronavirus vaccines has been a long time coming: My colleagues Lena Sun and Rachel Roubein, with a little help from me, wrote in September about Trump health officials’ pending plans to link coronavirus vaccines with children’s deaths.
The claim is also based on reports submitted to the federal Vaccine Adverse Event Reporting System, or VAERS, which contains unverified data.
I covered Kennedy’s Senate confirmation as health secretary, and several lawmakers pointed out that his frequent requests for more data on vaccine safety, especially on seemingly settled questions, is another way to create red tape and delay access to vaccines.