FDA Releases Covid-19 Vaccine Guidelines, and Nobody’s Happy
The White House initially blocked the guidelines for being too strict. A group of doctors say they’re not strict enough.
On Tuesday, the U.S. Food and Drug Administration (FDA) released new, stricter guidelines for an Emergency Use Authorization of a vaccine to prevent Covid-19. The guidelines come after weeks of back and forth with the White House and reports that the Trump administration was blocking their release.
At the heart of the debate is how much time must pass before a vaccine will be considered for approval. The new guidelines say clinical trial participants must be followed for a median of two months after receiving the experimental drugs. The White House complained that this was too long and wanted a shorter timeline, especially as the requirement pretty much guarantees a vaccine will not be available before the November election.
However, in a letter to the FDA also issued yesterday, a group of more than 60 physicians and infectious disease experts say the guidelines still don’t go far enough. They request that two months be the minimum amount of time that all participants are followed — not the median — because the new guidelines open the door for some people to be followed for less time. Their…
