A day after the White House blocked the formal publication by the Food & Drug Administration of updated safety guideline for any emergency approval of a coronavirus vaccine, the agency “informally” published this standards in briefing documents posted on the FDA website.
The most important item: The FDA said vaccine makers should follow vaccine trial participants for at least two months to rule out safety issues before seeking emergency approval. That requirement pretty much puts an end to the Trump administration’s dreams of an approved vaccine before the November 3 elections. President Donald Trump has repeatedly insisted a vaccine could be authorized before Election Day. On Monday the President said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.
Former FDA officials and public health experts have warned that the FDA would slow uptake of any approved vaccine if a significant portion of the U.S. population concluded a vaccine was being rushed out for political reasons.
In blocking the formal publication of the guidelines on Monday the White House had argued that there was “no clinical or medical reason” for the requirement of a 2-month safety review period.
The FDA tucked the updated guidelines into a memo posted ahead of an October 22 meeting of its outside vaccine advisory panel. The memo makes it clear that the FDA plans to impose the longer safety review standards for any vaccine seeking an emergency use approval. To meet the FDA’s guidelines, companies would need to submit two months of follow-up from half of their trial participants after they receive their last vaccine dose to show there are no major side effects or health problems. The FDA has already communicated its expectations to drug companies now running trials, an FDA spokesperson said today. “The companies know what we’re expecting,” said Dr. Peter Marks, the head of FDA’s vaccine division, in interview last week.