Moderna is seeking FDA approval for the 4th dose of COVID shot

WASHINGTON (AP) – Pharmaceutical manufacturer Moderna on Thursday asked the Food and Drug Administration to approve 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 that the regulator approve a booster shot for all seniors.

In a press release, the company said that 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 another booster dose of the mRNA vaccine, ” including those at higher risk for COVID-19 due to age or comorbidities. “

U.S. officials have laid the groundwork for providing additional booster doses to strengthen vaccines’ protection against serious illness and death from COVID-19. The White House has sounded the alarm that it needs Congress to “quickly” approve more funds for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.

US health authorities are currently recommending a primary series of two doses of the Moderna vaccine and a booster dose months later.

Moderna said their request for an additional dose was based on “recently published data generated in the United States and Israel following the advent 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 from it.

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