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Moderna has requested the US Food and Drug Administration for emergency use authorization for a second COVID-19 booster shot for adults, they said on Thursday.
The company said in their news release, “The request to include adults over 18 years of age was made to provide flexibility for the U.S. 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.”
They added, “This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron.”
Pfizer and BioNTech also submitted a request on Tuesday to the FDA for EUA of a second booster, but it was only for adults 65 and older.
A study shows that a fourth dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine was safe and boosted antibody levels similar to having received a third dose. The study was on health care workers in Israel and was published in the New England Journal of Medicine.
As of writing, second booster shots have been authorized in the US only for people who have weaker immune systems, but a few countries are already offering fourth doses.
The FDA responded that it will first convene its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, in April “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.” A date for the meeting is yet to be announced.
