FDA to announce tougher standards for a coronavirus vaccine that make it unlikely one will be cleared by Election Day

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Tue, 2020-09-22 17:59 — mike kraft

FDA to announce tougher standards for a coronavirus vaccine that make it unlikely one will be cleared by Election Day The guidance is part of an effort to boost transparency and public trust as polls show many are skeptical a vaccine will be safe and effective. Laurie McGinley, Carolyn Y. Johnson Washington Post

The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.

The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.

The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.

The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that has made missteps during the pandemic. With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.

As a sign the vaccine works, the agency also is likely to look for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people.

These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable any vaccine will be authorized before the election. The agency has previously said any vaccine would have to be 50 percent more effective than a placebo. ...

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