F.D.A. to Release Stricter Guidelines for Emergency Vaccine Authorization
The new guidelines underscore the fact that a vaccine is highly unlikely before the election.
By Noah Weiland and Sharon LaFraniere
The Food and Drug Administration plans to soon issue stricter guidelines for the emergency authorization of any new coronavirus vaccine, adding a new layer of caution to the vetting process even as President Trump continues to contradict his own scientific experts and promise that a vaccine will be available as early as next month.
The guidelines, which may be formally released as early as this week if approved by the White House, would lay out more specific criteria for clinical trial data and recommend that the data be vetted by a committee of independent experts before the F.D.A. authorizes any vaccine, according to several people familiar with the draft.
The guidelines would be the most detailed description yet by the federal government about how the vaccine vetting process will proceed.
With the election just six weeks away, Mr. Trump has repeatedly promised that the nation’s problems will soon be solved with a vaccine, although no vaccine has yet been proven to work. His own scientific experts continue to counter his statements, telling Congress that it will likely be the middle of next year, if not later, before a vaccine is readily available to most Americans.
Drafted by a small group of career scientists at the F.D.A., the guidelines state that participants in late-stage trials should be tracked for a median of two months after receiving the final dose before an emergency authorization can be considered. Three companies with vaccine candidates in Phase 3 trials — Pfizer, AstraZeneca and Moderna — all require two doses. (AstraZeneca’s trial is now paused in the United States because of safety concerns.)
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