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Moderna seeks FDA authorization for 4th dose of COVID shot

FILE - In this March 4, 2021 file photo, a vial of the Moderna COVID-19 vaccine rests on a table at a drive-up mass vaccination site in Puyallup, Wash., south of Seattle. Modernas COVID-19 vaccine brought in nearly $7 billion in the final quarter of 2021, and the drugmaker says it has signed purchase agreements for another $19 billion in sales this year. (AP Photo/Ted S. Warren, File) (Ted S. Warren, Copyright 2021 The Associated Press. All rights reserved.)

WASHINGTON – Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors.

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In a press release, the company said its request for approval for all adults was made ā€œto provide flexibilityā€ to the Centers for Disease Control and Prevention and medical providers to determine the ā€œappropriate useā€ of a second booster dose of the mRNA vaccine, ā€œincluding for those at higher risk of COVID-19 due to age or comorbidities."

U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to ā€œurgentlyā€ approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.

U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later.

Moderna said its request for an additional dose was based on ā€œrecently published data generated in the United States and Israel following the emergence of Omicron.ā€

On Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.