Pfizer and BioNTech have applied for FDA authorization of their reformulated COVID-19 booster dose, which targets Omicron subtypes BA.4 and BA.5 as well as the original strain of SARS-CoV-2. Omicron cases are now dominant in the United States, but research has suggested that currently approved vaccines are less effective against the mutation and its subtypes. Human trials of the modified vaccine are only now about to kick off, according to the companies; however, animal studies yielded favorable results. The manufacturing partners are already making doses of the bivalent boosters and stand prepared to distribute them to the U.S. government ahead of a fall vaccination campaign. The goal is to blunt the effect of a potential surge in cases during the colder months. FDA is expected to sanction the new boosters in time for the booster drive. It also is likely to soon receive an application from Moderna for its bivalent vaccine.
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