Moderna seeks FDA approval for 4th dose COVID shot

This request is more extensive than Pfizer’s earlier request to the regulator for a booster shot for seniors.

The company stated in a press release that it requested approval for all adults “to give flexibility” to the Centers for Disease Control and Prevention and to medical providers to determine “appropriate use of a second booster dose” of the mRNA vaccination, “including for those who are at higher risk for COVID-19 because of age or comorbidities.”

U.S. officials are preparing to distribute additional booster doses in order to strengthen the vaccines’ defense against COVID-19-related death and serious disease. The White House is urging Congress to approve additional funding to the federal government in order to obtain more COVID-19 vaccines. This could be for booster shots or variant-specific vaccinations.

U.S. officials recommend that a primary series consisting of two doses each of the Moderna vaccine be administered, with a booster dose given months later.

Moderna stated that its request for an extra dose was based upon “recently published data from Israel and the United States following the emergence Omicron.”

Pfizer and BioNTech, their partner, asked the U.S. regulators Tuesday to approve an additional dose of their COVID-19 vaccination for seniors. They cited data from Israel that suggests older people would benefit.

 

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