Moderna seeks FDA authorization for a second booster dose of its coronavirus vaccine for all adults - The Washington Post

Biotechnology company Moderna on Thursday asked the Food and Drug Administration to allow adults 18 and older to receive a second booster shot of the company’s mRNA vaccine amid concerns that immune protection from the vaccines wanes over time.

Moderna’s application is substantially broader than what Pfizer and its German partner, BioNTech, sought earlier in the week — FDA authorization for a second booster shot for adults 65 and older.

The applications by the makers of the two messenger RNA vaccines, which account for almost all of the vaccines distributed in the United States, are sure to intensify the debate about the durability of the protection afforded by the coronavirus vaccines — a topic that has divided the scientific community.

Both Pfizer-BioNTech and Moderna have said their requests to allow for a second booster shot are based in part on recent data from Israel that shows decreased vaccine efficacy during the omicron surge. Moderna, whose booster application was first reported by the New York Times, is still conducting clinical trials for an omicron-specific booster shot.

Studies and real-world data show that booster protection remains strong against severe illness and death but wanes against infections after several months.

In a recent interview, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said U.S. data so far shows that protection against severe illness remains robust four to five months after a booster, falling somewhat from 91 percent effectiveness in preventing severe illness to 78 percent.

Moderna said in a statement Thursday that it requested the second booster shot be authorized for all adults to give the Centers for Disease Control and Prevention and doctors more flexibility in deciding which patients might be good candidates for an additional dose of the vaccine.

The decision from the FDA could come relatively quickly, especially if officials conclude the data is straightforward and does not have to be reviewed by a panel of outside vaccine experts. CDC advisers would then weigh in on who should be eligible for a second booster dose, and the CDC director would have the final say on those recommendations.

The two-dose Moderna vaccine received full FDA approval for adults in January after getting emergency use authorization in December 2020. The FDA authorized a booster shot of the messenger RNA vaccines in November.

“Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine,” the company said in a statement.

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