Moderna seeks FDA approval to authorize booster shots

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Moderna seeks FDA approval to authorize booster shots

Moderna filed an application Wednesday with the Food and Drug Administration seeking emergency use authorization of vaccine booster shots for all Americans ages 18 and up.

The vaccine manufacturer announced the EUA request in a statement on its website Wednesday afternoon. The FDA’s regulators approved last month a third Moderna shot for seniors and others at high risk from the virus who got their second dose more than six months prior.

The company’s booster vaccine for adults “regardless of occupational risk factors” is already authorized in many international markets, Moderna said.

If ultimately approved, the authorization would pave the way for tens of millions of Americans to get a third vaccine dose that’s the equivalent of half of one of the initial shots.

The Pfizer-BioNTech booster shot, meanwhile, was granted emergency approval by the FDA for vulnerable populations in late September. But regulators rejected a more widespread rollout amid questions whether healthy young people needed the additional dose when much of the world remains unvaccinated. Pfizer last week asked federal regulators to expand booster eligibility to all Americans.

Syringes filled with doses of Moderna's COVID-19 vaccine.
Last month, the FDA approved a third Moderna shot for seniors and others at high risk from COVID-19.
Arnd Wiegmann/REUTERS

A panel of Centers for Disease Control and Prevention experts is set to convene Friday to discuss data regarding Pfizer’s request for the booster shots to be doled out to all Americans rather than just those at high risk.

The FDA, meanwhile, is aiming to authorize booster doses of the Pfizer-BioNTech vaccine as early as Thursday, the New York Times reported, citing sources familiar with the agency’s plans.

At least 30 to 40 percent of vaccinated adults remain excluded from booster eligibility, while more than 30 million people have received them, according to estimates cited by the newspaper.

A woman receives a booster shot of Moderna's COVID-19 vaccine.
At least 30 to 40 percent of vaccinated adults remain excluded from booster eligibility.
Arnd Wiegmann/REUTERS

Health officials in New York City announced Monday that all adults who got a Moderna or Pfizer booster at least six months earlier were eligible for boosters. Those who got the single-shot Johnson & Johnson vaccine should wait at least two months.

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