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 concern is that adverse reactions to the vaccines could arise that wouldn’t be caught in the condensed timeline.
The authors of the letter write, “Under the FDA’s proposed lower bar, a vaccine could be authorized before many trial participants have been observed through the period when most adverse vaccine events occur.”
In an email to Medium’s Coronavirus Blog, one of the signees, Celine Gounder, MD, a clinical assistant professor of medicine and infectious diseases at the NYU School of Medicine, says, “Two months is pretty short and really a safety minimum. The fact that the White House is pushing on such a minimum is alarming.”
The duration of a vaccine trial is typically based on how long the scientists think it will take to see a significant effect compared with a placebo. That depends on how many people are enrolled in the trial and how likely an infection is. If more people naturally get infected quickly…