Vaccine makers may have to provide two months of safety data before the Food and Drug Administration will approve a vaccine despite reports yesterday that the agency’s safety requirement had been blocked by the White House.
The requirement would set up a showdown with the White House as President Trump has insisted that a vaccine could be approved before Election Day.
Yesterday, the White House said there was “no clinical or medical reason” for the additional requirement. The FDA, however, sought other ways to impose the two-month standard, including having an outside advisory committee enforce it, the New York Times reported.
That committee, called the Vaccines and Related Biological Products Advisory Committee, released its briefing document Tuesday for its meeting on Oct. 22. It spells out the “safety and effectiveness information” that vaccine makers must provide to the FDA in order for it to approve an emergency use authorization. That includes data on “a median follow-up duration of at least two months after completion of the full vaccination regimen” that shows whether participants in phase 3 trials had any adverse effects.
The two-month guideline would make it nearly impossible for a vaccine to be approved prior to the Nov. 3 election. The White House has been battling with the FDA over guidelines for an emergency use authorization of a coronavirus vaccine for weeks.
When the FDA first released its guidelines, Trump doubted whether they would be approved. “We may or may not approve it,” he said on Sept. 23. He said the regulations were “a political move more than anything else.”
Even without the guideline, approval of a vaccine before Election Day is unlikely. Pfizer is currently the only vaccine developer far enough along in the process to receive an emergency use authorization from the FDA.
