Moderna yesterday announced that it has submitted an application to the Food and Drug Administration (FDA) for emergency use of its bivalent (two-strain) COVID booster vaccine that targets the BA.4/BA.5 Omicron subvariants, following a similar move this week from Pfizer and BioNTech.
Moderna on track to deliver in September
In a statement, Moderna said its application is for a 50-microgram booster dose for adults ages 18 and older. It targets the original SARS-CoV-2 strain, plus the Omicron BA.4 and BA.5 subvariants.
BA.5 is still the dominant subvariant, and with circulation still at high levels in many parts of the country, US health officials are looking toward more finely-tuned boosters as a way to blunt possible surges in the fall as schools resume and as more people gather indoors.
The Biden administration has signaled that it will offer updated boosters to people ages 12 and older soon after Labor Day, according to the New York Times. The Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices is slated to meet on Sep 1 and Sep 2 to review the data and make recommendations.
As with Pfizer-BioNTech’s bivalent booster, which the companies submitted for emergency use authorization (EUA) consideration on Aug 22, Moderna submitted preclinical and manufacturing data, as well as clinical data for the bivalent BA.1 booster that it began developing earlier.
The company said a phase 2/3 trial of the BA.4/BA.5 targeted booster is already under way and that it has rapidly scaled up manufacturing to be ready, if authorized, to deliver doses in September.
Center for Infectious Disease Research and Policy, University of Minnesota