Moderna seeks FDA authorization for 4th dose of COVID shot

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

Associated Press
Zeke Miller

March 17, 2022

A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore., Monday, Dec. 27, 2021. U.S. regulators have granted full approval to Moderna’s COVID-19 vaccine after reviewing additional data on its safety and effectiveness. The decision Monday, Jan. 31, 2022 by the Food and Drug Administration comes after many tens of millions of Americans have already received the shot under its original emergency authorization. Full approval means FDA has completed the same rigorous, time-consuming review for Moderna’s shot as dozens of other long-established vaccines. (AP Photo/Jenny Kane)

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.

In a press release, the company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities.”

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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 “urgently” 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 “recently published data generated in the United States and Israel following the emergence of Omicron.”

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.

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