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Moderna seeks FDA authorization for 4th dose of COVID shot

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

The demand is wider than the request of the competing pharmaceutical company Pfizer earlier this week for the regulator to approve a booster dose for all seniors.

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

U.S. officials have laid the groundwork for additional boosters to boost vaccine protection against serious illness and death from COVID-19. The White House is sounding the alarm that Congress needs to “urgently” approve more funding for the federal government to secure more doses of COVID-19 vaccines, whether for additional vaccines or special vaccinations.

U.S. health officials are currently recommending a main 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 appearance of Omicron”.

On Tuesday, Pfizer and a BioNTech partner asked U.S. regulators to approve an additional booster dose of their COVID-19 vaccine for the elderly, saying data from Israel suggest the elderly will benefit.

Copyright © 2022 by the Associated Press. All rights reserved.



Moderna seeks FDA authorization for 4th dose of COVID shot Source link Moderna seeks FDA authorization for 4th dose of COVID shot

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