Pfizer and BioNTech have submitted their application to the US Food and Drug Administration for emergency use authorization of their bivalent Covid-19 vaccine for use in people age 12 and older, the companies said in a statement on Monday.
This updated formulation will combine the original vaccine with one that targets Omicron sublineages BA.4 and BA.5, and would be administered as a 30 microgram dose. The companies say they are following “guidance from the FDA” and are including clinical data of their bivalent BA.1 vaccine and pre-clinical and manufacturing data from the bivalent BA.4/5 vaccine for the submission.
“FDA will be using the totality of the available evidence to authorize the fall bivalent boosters,” FDA spokesperson Abigail Capobianco said in a statement emailed to CNN last week. “There are data on many millions of individuals who have received the prototype component as a booster. As for the BA.4/5 component, a combination of nonclinical data obtained in mice, data from prior variant vaccines (including those to beta, delta, and omicron BA.1), along with our extensive knowledge of the safety and efficacy of the mRNA platforms will be used for this decision-making.”