Moderna, Pfizer Want FDA to OK Second Boosters

Ralph Ellis

March 18, 2022

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Moderna and Pfizer are seeking FDA approval for second COVID-19 booster shots.

On Thursday, Moderna formally requested the FDA grant emergency authorization for a second booster shot of its COVID-19 vaccine for all adults over 18 who've received approved vaccines.

Earlier this week, on Tuesday, Pfizer and its partner BioNTech also requested authorization for a second booster shot, but only for people over 65 who've been vaccinated.

In news releases, Moderna and Pfizer said their requests were based in part on data from Israel, after the emergence of the Omicron variant, that showed a second booster lowers rates of infection and severe illness.

Moderna said it sought authorization for everybody over 18 to give government health authorities "flexibility" in deciding which age groups would most benefit from the booster.

The FDA might grant authorization quickly if the pharmaceutical companies' data doesn't have to be reviewed by outside vaccine experts, The Washington Post reported. The CDC director would ultimately determine which age groups should get the second booster dose.

The requests were filed as studies show that the vaccines get less effective over time.

A study published in February by the CDC showed that booster shots of the Pfizer/BioNTech and Moderna COVID-19 vaccines got less effective after 4 months but still did a good job of keeping people out of the hospital during the Omicron surge.

While the Omicron variant was dominant, the vaccines were 87% effective against emergency room visits and 91% effective against hospitalizations 2 months after the booster, the study showed. Four months after the booster shot, effectiveness dropped to 66% against ER visits and 78% against hospitalizations.

At this time, the CDC recommends vaccination and a booster for everyone 12 and older and two doses for those 5 to 11. People with weakened immune systems are already encouraged to get another dose.

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