Moderna Seeks FDA Authorization for Fourth COVID-19 Shot
(Washington, D.C.) — Drugmaker Moderna asked 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 company 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” to the Centers for Disease Control and Prevention and medical providers to determine 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.”
U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines’ protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to “urgently” approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.
U.S. Health officials suggest a primary dose of Moderna with 2 doses and then another booster dose several 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.”
Pfizer and BioNTech asked U.S. regulators Tuesday to allow an additional dose of the COVID-19 booster vaccine for senior citizens. They cited data from Israel that suggests this would help older people.
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