FDA to Toughen Vaccine Approval Rules, Dealing Blow to Trump’s Pre-Election Vaccine Claims

The FDA is expected to roll out tougher standards for an emergency authorization for a coronavirus vaccine as early as this week, dealing a blow to President Donald Trump’s claim that a vaccine could arrive ahead of the election, The Washington Post reports.

The guidance is expected to be much stricter than the emergency use authorization standards used to clear hydroxychloroquine and convalescent plasma.

The guidelines are still being reviewed by the White House but have already been shared with vaccine manufacturers.

Vaccine makers must monitor large-scale clinical trials for at least two months after participants received their second dose.

The vaccine would also have to be 50% more effective than a placebo.

Vaccine not likely by election:

The standard will likely make it improbable that a vaccine would arrive by the election.

“It’s hard to imagine how an [emergency use authorization] could possibly occur before December,” said Paul Offit, a member of the FDA’s advisory board on vaccines, told the Post.

Moderna and Pfizer both launched their trials in late July and reached 15,000 participants in August. The participants were expected to get their second dose three to four weeks later.

With two months of necessary follow-up, it is unlikely the companies will have enough data to get authorization before mid-November.

FDA trying to shore up vaccine confidence:

The new guidance is aimed at shoring up confidence in the coming vaccine.

The number of people who said they would take a vaccine when it is available has dropped from 72% in May to 50%.

Some say the FDA should not use an emergency authorization on a vaccine at all.

“Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.”


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