exclusive
How two top FDA officials are quietly upending vaccine regulations
Mike Reddy for STAT
The FDA has limited access to Covid-19 vaccines in a number of ways this year. And while many observers point to Kennedy as the source behind these changes, a new investigation by STAT's Lizzy Lawrence shows how two leaders at the agency are driving plans to reshape vaccine regulation far beyond Covid-19.
You know the players: special assistant and clinical advisor Tracy Beth Høeg and vaccine center director Vinay Prasad. The two have seized control from career scientists who run the FDA's vaccine surveillance programs, changing procedures rapidly with little staff input. "Why don't you want people that have been doing this all their life to weigh in?" said Kathryn Edwards, a former advisory committee member and vaccinologist.
Høeg and Prasad are working on making it harder for doctors to offer different vaccines at the same time, and are unilaterally changing study designs to try and pick up more adverse events from vaccines. In September, Høeg suggested a label change that would make it prohibitively difficult for young men to receive Covid shots, based on thin evidence. She backed down after staff pushed back.
Read Lizzy's thorough investigation, for which she spoke with more than 20 current and former FDA employees, contractors, and experts, and reviewed all sorts of data, regulatory documents, internal memos, and emails.
what's the word
The heart's chambers & my favorite bubble tea flavor
I'm still finding STAT's weekly mini crossword to be difficult, but I did better this week than I have in the past. How will you do? Find out here.
first opinion
A pro-vaccine doctor attended the biggest anti-vax gathering around
In more MAHA meeting news: Children's Health Defense, the vaccine-skeptical organization once led by Kennedy, currently has more power in Washington than its leaders ever imagined possible. Craig Spencer, a public health professor and emergency medicine physician, doesn't ascribe to the group's beliefs. But last weekend, he traveled to Austin, Texas, to attend the group's first conference since Kennedy took the helm at HHS. He wanted to hear how this movement wins people over, and why its message resonates so deeply.
"What's easy to miss from the outside is that this isn't chaos — it's community," Spencer writes in a new First Opinion essay. Movement leader Del Bigtree proclaimed "God is an anti-vaxxer," while wellness influencers worried about Wi-Fi and crypto enthusiasts traded peer-to-peer coins. Read more on Spencer's experience crossing the aisle, and why he thinks more physicians should do the same.
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