Moderna requests FDA authorization for fourth COVID-19 shot

(Washington, DC) — Drugmaker Moderna on Thursday asked the Food and Drug Administration to allow a fourth injection 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 to the regulator to approve a booster shot for all seniors.

In a press release, the company said the request for approval for all adults was made “to provide flexibility” for 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 those at higher risk for COVID-19 due to age or co-morbidities.”

US officials have laid the groundwork for delivering additional booster doses to bolster vaccines’ protection against serious illness and death from COVID-19. The White House has raised 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 are currently recommending 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 after the rise of Omicron.”

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

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