Moderna seeks FDA authorization for 4th dose of COVID shot

Drugmaker Moderna requested the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

The request is broader than rival pharmaceutical firm Pfizer’s request earlier this week for the regulator to approve a booster shot for all seniors.

In a press launch, the corporate stated its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical suppliers to find out the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities.”

Moderna COVID-19 vaccine vials seen on a table
Moderna COVID-19 vaccine vials

Jdidi Wassim/SOPA Images/LightRocket through Getty Images

U.S. officers have been laying the groundwork to ship extra booster doses to shore up the vaccines’ safety in opposition to severe illness and demise from COVID-19. The White House has been sounding the alarm that it wants Congress to “urgently” approve extra funding for the federal authorities to safe extra doses of the COVID-19 vaccines, both for added booster photographs or variant-specific immunizations.

U.S. well being officers at the moment suggest a major collection of two doses of the Moderna vaccine and a booster dose months later.

Moderna stated its request for an extra dose was based mostly on “recently published data generated in the United States and Israel following the emergence of Omicron.”

On Tuesday, Pfizer and its companion BioNTech requested U.S. regulators to authorize an extra booster dose of their COVID-19 vaccine for seniors, saying information from Israel suggests older adults would profit.

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