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Moderna is seeking FDA approval for 4th dose of COVID vaccine

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

The request is broader than competing pharmaceutical companies 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 for Centers for Disease Control and Prevention and healthcare providers” to determine the “appropriate use” of a second booster dose of the mRNA vaccine to determine. “including for those at higher risk of COVID-19 due to age or comorbidities.”

US officials have laid the groundwork for administering additional booster doses to bolster vaccines’ protection against serious illness and death from COVID-19. The White House has sounded the alarm that Congress must “urgently” approve more funds for the federal government to secure more doses of the COVID-19 vaccines, either for additional boosters or variant-specific immunizations.

US health officials currently recommend a first series of two doses of the Moderna vaccine, followed by 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 approve an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

A sign marks an entrance to a Moderna building in Cambridge, Mass.
Moderna said its request for approval for all adults was made “to provide flexibility for the Centers for Disease Control and Prevention and healthcare providers” to determine the “appropriate use” of a second booster.
Bill Sikes/AP
A local resident receives the booster shot of the Moderna coronavirus vaccine.
Earlier this week, Pfizer applied for approval for a booster shot for all seniors.
AP/Eugene Hoshiko

https://nypost.com/2022/03/17/moderna-seeks-fda-authorization-for-4th-dose-of-covid-shot/ Moderna is seeking FDA approval for 4th dose of COVID vaccine

JACLYN DIAZ

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