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Moderna is seeking an amendment of the US Food and Drug Administration’s emergency use authorization for its COVID-19 vaccine to allow for a fourth vaccine to adults 18 and older who have gotten an initial booster.
The move by Moderna comes days after Pfizer and BioNTech submitted a similar request for authorization of an additional booster shot, though that vaccine would only be eligible for adults 65 and older.
“The request to include adults over 18 years of age was made to provide flexibility for the US Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities,” the company announced.
"This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron.”
The FDA is planning to meet its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, next month "to have a transparent discussion about considerations for 2022 booster shots, including whether and when those boosters may be needed and for which populations, based on the available data and latest science on circulating or emerging virus variants.”
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