FDA appears unconvinced by Pfizer's case for Covid-19 booster in lead up to adcomm
At around 9 a.m. on Wednesday morning, the FDA released Pfizer’s detailed case to the agency and its outside advisors for authorizing Covid-19 booster doses. Three hours later, the FDA released its own analysis.
For most of the documents, it is as if the agency and the company are having two different conversations.
The documents provide a prelude for an advisory committee hearing that will debate whether the agency should approve booster shots. The issue has proven deeply polarizing. President Biden has promised to authorize boosters based on data from Israel and elsewhere, angering some public health officials in and outside the FDA, who fear the president is interfering in the agency’s independence and argue that existing data don’t support such shots, especially when much of the world remains unvaccinated.
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