Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine.
Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older.
In its submission, Moderna included data gathered from the U.S. and Israel after the emergence of the omicron variant.
Data on the efficacy of a fourth dose of Moderna’s vaccine against omicron were recently published in NEJM. The researchers, considering data from the Moderna and Pfizer-BioNTech vaccines, concluded that a fourth dose of mRNA vaccine appears to be “immunogenic, safe, and somewhat efficacious (primarily against symptomatic disease).”
In January, early data from Israel’s Sheba Medical Center indicated that an additional booster of COVID-19 vaccine from Pfizer and BioNTech drove to a fivefold increase in antibodies one week after administration of the vaccine.
FDA approved Moderna’s COVID-19 vaccine on January 31. A primary series of the vaccine consists of two 100 µg doses of the vaccine.
The agency permitted a 50 µg booster dose of the vaccine under emergency use authorization. FDA also allows a 100 µg booster for moderately to severely immunocompromised individuals.
Moderna’s most recent request would amend the emergency use authorization pertaining to booster doses of the vaccine.
Moderna continues to develop an omicron-specific booster known as mRNA-1273.529 and a bivalent omicron-specific booster known as mRNA-1273.214.
In April, the FDA will convene a meeting of its advisory committee, the Vaccines and Related Biological Products Advisory Committee.