By Alice Seeley
On March 17, Moderna announced that it requested emergency use authorization from the Food and Drug Administration for a second COVID-19 booster shot for all adults. Currently, a single booster dose of Moderna’s mRNA vaccine is only authorized for emergency use.
The two-dose Moderna vaccine was granted emergency use approval in December 2020 and received full FDA approval in January 2021. Then in November 2021, the FDA authorized a booster shot of the mRNA vaccines. Adults who are immunocompromised are already authorized to receive fourth doses of the mRNA vaccines. Moderna’s request for authorization came shortly after Pfizer announced that it also asked for emergency authorization for a second booster for adults 65 and older.
In a press release, Moderna 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.”
Moderna’s request is based on “recently published data generated in the United States and Israel following the emergence of Omicron.” Moderna stated that “real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine.”
It is not clear how long it will take for the FDA to decide. The process could move quickly if the FDA concludes the data is clear and does not have to be reviewed by a panel of outside vaccine experts. CDC advisers would then decide who should be eligible for a second booster dose. The CDC director would have the final say on those recommendations.
The FDA will have a meeting of its advisory committee of vaccine experts next month to discuss how to approach COVID booster shots. The committee will discuss if booster shots are necessary and, if so, for what age groups.
