Calls mount on FDA to formally endorse Covid vaccines as Delta surges

www.politico.com
4 min read
fairly difficult
"I don't think there's anything that can move the needle more in the U.S.," said Eric Topol, a professor of molecular medicine at Scripps Research, about the unvaccinated who are eligible to get the shot.
More than 183 million doses of the Pfizer vaccine and 135 million doses of Moderna's have been administered in the U.S., according to the CDC, and their rollout has correlated with a steep decline in Covid-19 cases since January. The vast majority of Covid-related hospitalizations and deaths are now occurring among unvaccinated populations.

"That's as good as gets when it comes to having data on safety and efficacy," said Céline Gounder, an infectious disease specialist and epidemiologist at New York's Bellevue Hospital. "We have it in real life — what more can people ask for?"

Still, it's unclear how much full licensure of the vaccines will spur unvaccinated Americans to get their shots. Polling released June 30 by the Kaiser Family Foundation showed that nearly a third of unvaccinated adults — and about half of those who said they're taking a "wait and see" approach to the vaccine — said they'd be more likely to get it if the FDA fully approved one of the shots.

FDA spokesperson Abby Capobianco said the agency is working quickly to assess the companies' applications, though she declined to offer a timeline for approval.

"Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA's rigorous standards for safety, effectiveness, and manufacturing quality," she said.

Pfizer and Moderna each submitted their applications on a rolling basis, meaning they'd submit sections to the FDA as they're finished as opposed to waiting for the entire document to be completed. Both companies are…
Lauren Gardner
Read full article