Moderna seeks FDA clearance for 4th dose of COVID

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

WASHINGTON (AP) — Drugmaker Moderna on Thursday asked the Food and Drug Administration 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 give flexibility” to the Centers for Disease Control and Prevention and medical providers to determine “appropriate use.” a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities.”

US officials have set the stage for providing additional booster doses to bolster vaccine protection against serious illness and death from COVID-19. The White House has sounded the alarm that it needs Congress to “urgently” approve more funding for the federal government to get more doses of COVID-19 vaccines, either for injections of additional boosters or for variant-specific vaccinations.

US health officials are currently recommending a two-dose primary series 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 allow an additional booster dose of their COVID-19 vaccine for older adults, saying data from Israel suggests older adults would benefit.

Zeke Miller, The Associated Press


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