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Moderna has asked the US Food and Drug Administration for authorization for a second Covid-19 booster shot for everyone 18 and older, they said on Thursday.
Moderna seeks to amend the FDA’s emergency use authorization for its COVID-19 vaccine, which would allow a fourth vaccine dose for any adults who have received an initial booster.
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 to the FDA for EUA of an additional booster of their COVID-19 vaccine on Tuesday, but it was only for adults aged 65 years old and older.
A study of health care workers in Israel published in the New England Journal of Medicine discovered that a fourth dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine was safe and boosted antibody levels similar to what was observed after a third dose.
Currently, fourth vaccine doses have been given the go signal in the US only for people who are immunocompromised. However, a few countries are already offering fourth doses.
The FDA responded that it will 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 announced.
