Trump stoked concerns of politicizing the regulatory approval process with an
announcement on Sunday of an emergency use authorization for plasma from recovered
COVID-19 patients to treat current patients before its benefits have been assessed in
randomized, placebo-controlled clinical trials.

Trump had tweeted on Saturday that “deep state” elements at the FDA were delaying
progress on drugs and vaccines until after the Nov. 3 election in order to hurt his
reelection bid.

Safe and effective vaccines are seen as essential to ending the pandemic that has
claimed the lives of more than 800,000 people worldwide, over 177,000 of them in the
United States.

But vaccine experts worry that the White House may apply pressure on the FDA to push
out a vaccine via an EUA before it has been fully tested - a pathway that has never
been used to approve a vaccine intended for widespread use.
“I would be very worried about using an EUA mechanism for something like a vaccine.
It’s very different from plasma therapy,” said Dr. Peter Hotez, an infectious
disease expert and vaccine researcher at Baylor College of Medicine.

Fauci said the FDA’s guidance on vaccines - both for full approval and for an EUA
- explicitly requires a demonstration that it is both safe and effective.
An EUA is typically used for products to “diagnose, prevent and treat serious or
life-threatening diseases where the known benefits outweigh the potential risks of
the product,” Fauci said.