Pfizer and BioNTech have asked the FDA to authorize an updated version of their COVID-19 vaccine for this fall — this one designed specifically to target the omicron subvariants that are dominant in the U.S.
The new"bivalent" booster — meaning it's a mix of two versions of the vaccine — will target both the original coronavirus strain and the BA.4 and BA.5 omicron subvariants.
Following the FDA's guidance, the data the drugmakers are submitting represents a departure from what's been used in earlier vaccine authorizations. "We're going to use all of these data that we've learned through not only this vaccine but decades of viral immunology to say: 'The way to be nimble is that we're going to do those animal studies,", an immunobiologist at the University of Arizona College of Medicine in Tucson, told NPR recently."We're really not going out too far on a limb here."
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