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Moderna has filed a request before the US Food and Drug Administration for authorization for a second COVID-19 booster shot for adults, they said on Thursday.
Moderna requested to amend the FDA’s emergency use authorization for its COVID-19 vaccine, which allows a fourth vaccine dose for any adults who have received an initial booster.
The company revealed 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.”
On Tuesday, Pfizer and BioNTech also submitted a request to the FDA for EUA of an additional booster of their COVID-19 vaccine, but it was only for adults aged 65 years old and older.
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, a study says. The study was on health care workers in israel and was published in the New England Journal of Medicine.
Currently, second booster shots have been given approval 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 the Vaccines and Related Biological Products Advisory Committee — its independent vaccine advisers — 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 has not been revealed.
