"We're really not going out too far on a limb here." "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," Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine in Tucson, told NPR recently. Regulators will rely on those results - along with the human neutralizing antibody data from earlier BA.1 bivalent booster studies - to decide whether to authorize the boosters. Instead of waiting for results from human trials, the FDA asked the drug companies to initially submit only the results of tests on mice, as NPR reported last week. If the vaccine is authorized by the FDA, distribution could start "immediately" to help the country prepare for potential fall and winter surges of the coronavirus, Pfizer CEO Albert Bourla said in a statement.įollowing the FDA's guidance, the data the drugmakers are submitting represents a departure from what's been used in earlier vaccine authorizations. 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.
Pfizer and BioNTech said they have submitted pre-clinical data on vaccine efficacy to the FDA, but did not share the data publicly. More than 90% of cases are caused by the BA.4 and BA.5 subvariants, which took off this summer, but the vaccines being used were designed for the original coronavirus strain from several years ago. On Monday, the drugmakers Pfizer and BioNTech announced that they've asked the Food and Drug Administration to authorize an updated version of their COVID-19 vaccine - this one designed specifically to target the omicron subvariants that are dominant in the U.S. is one step closer to having new COVID-19 booster shots available as soon as this fall.
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