The Food and Drug Administration is about to publish the upper criteria before passing a COVID-19 vaccine, the Washington Post reported Tuesday, a move that could boost any vaccine deployed until after the November election.
A COVID-19 vaccine would almost be approved through an emergency use authorization, authorities said, a tool that allows the government to approve remedies before full multi-year control regimens are completed.
Citing two anonymous sources, the Post reported that the FDA intended to seek emergency approval of vaccine brands to “follow participants in complex clinical trials for a median duration of at least two months, starting after receiving a momentary vaccine. “
The two maximum trials of complex vaccines, Moderna and Pfizer, require injections, one month apart. The first people to get the shooting time circular did so in the last week of August, suggesting that the new regulations would save you an application for authorization from the time it was issued until the end of October.
The new regulations would also require that there be at least five severe cases of COVID-19 in the placebo population of the trial, such as some cases of COVID-19 in the elderly, prior to approval.
The new criteria can make the FDA schedule larger to issue emergency approval for a vaccine. President Trump has said a vaccine would be approved before Election Day, while administration officials have called a pre-election vaccine a “holy grail” for the president. Trump’s hopes of re-election.
It is not known how new or strict the criteria are, compared to those used in the past by the FDA for the COVID-19 vaccine, while Operation Warp Speed, the Trump administration’s effort to drive vaccine development, has stated that any COVID-19 vaccine will have to be at least 50% effective to be approved , so far the FDA has not published the detailed criteria it uses to identify the protection and efficacy of the vaccine.
Joe Biden on Trump’s management to make those criteria publicly available.