As Delta Surges, FDA Pressured to Fully Approve COVID Vaccines

11 months ago 26

July 9, 2021 -- More and more experts are urging the FDA to grant full approval to the Pfizer and Moderna COVID-19 vaccines because it might jump-start the stalled national vaccination program and slow down the surge of the Delta variant infection.

The FDA granted emergency use authorization in December to those two vaccines, which are based on mRNA technology. Both companies have applied for full approval but it’s unclear when the FDA will act.

Eric Topol, a professor of molecular medicine at Scripps Research, and editor-in-chief of WebMD’s sister site, Medscape, is one scientist urging full approval soon.

In a guest essay in The New York Times, he wrote that people taking a wait-and-see attitude toward the vaccine might get a shot if the FDA granted full approval. Also, people might take the step if required by their employers.

“Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” Topol wrote. “Others may not get immunized unless their employers require it, and many organizations -- including, reportedly, the military -- are waiting for the vaccines to be fully approved before instituting such mandates.”

Topol said the rapid spread of the Delta variant is one reason for the FDA to move more quickly.

“The agency should make full approval its number one priority, and its leadership should communicate its plans to the public,” he wrote.

The CDC says 183 million doses of the Pfizer vaccine and 135 million doses of the Modern vaccine have been administered in the United States since December. Infections, hospitalizations, and deaths have dropped sharply since.

“That’s as good as it gets when it comes to having data on safety and efficacy," said Céline Gounder, MD, an epidemiologist at New York's Bellevue Hospital, ac...

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