FDA PLANS TO TIGHTEN VACCINE STANDARDS

Move would make clearance unlikely before Election Day

WASHINGTON

The Food and Drug Administration is expected tighten a 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 decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Donald Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s pressure on federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.

Polls show that the 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; it was 72 percent in May.

The guidance, which is 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 made missteps in its handling of those clearances.

In the case of vaccines, the FDA is expected to ask manufacturers seeking emergency authorization — a 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.

The agency also is looking for at least five severe cases of COVID-19, the illness caused by the novel coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people, as a sign the vaccine works. These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it improbable for any vaccine to be authorized before the election.

The guidance is one way of trying to shore up confidence in the agency. FDA allies, intent on building trust, are also spotlighting agency career scientists, noting that the one overseeing the vaccine-approval process has threatened to quit if he is pressured to greenlight a vaccine before he is convinced it is safe and effective.

But, administration critics note, such efforts are undercut by continued revelations about administration actions to pressure government scientists and regulators, and curb their independence.

In addition, the FDA guidance is unlikely to satisfy some critics, who say the agency should not use an emergency authorization for a vaccine at all.