Two high-level FDA officials abruptly resigned last week, amid reports that they were angry that the White House was making decisions that should be left up to the agency.
after reports of rising numbers of breakthrough infections, and demand only shot up after the Biden administration said they would begin offering those shots on Sept. 20., has raised eyebrows because it comes in advance of regulatory reviews by FDA and CDC, , which are required to determine whether third doses of these vaccines would be effective or even safe. The move could have important legal ramifications for doctors and their patients, too.
. The World Health Organization has also urged wealthy nations like the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.In a recent press briefing, Jeff Zients, the White House COVID-19 Response coordinator, defended the move.
Zietns said the announcement of a Sept. 20 target date was to give states and vaccine providers time to prepare, and that the move to give boosters was meant to help the U.S. stay ahead of a rapidly changing virus. Zients added that starting boosters on Sept. 20 would still depend on the FDA’s and CDC’s go ahead.
After the FDA approves, the CDC’s Advisory Committee on Immunization Practices must meet to review the evidence and make recommendations on the use of the boosters in the U.S. “It puts FDA in a very difficult position,” Lurie said. “It's almost as if the decision has been made and they're just checking a box and that is, you know, contrary to the what FDA -- at least the internal people at FDA -- have been trying to do for ages.”
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