Pfizer asks FDA to approve COVID-19 vaccine that targets omicron, original virus

Pfizer and BioNTech announced Monday that they have requested U.S. Food and Drug Administration authorization for a COVID-19 vaccine booster that targets not only the original virus, but also the omicron coronavirus subvariants.

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According to Pfizer, tests have shown the booster works well against both the original virus and the omicron strain, which is responsible for more than 90% of new cases of the virus in the U.S.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” said Albert Bourla, chairman and chief executive officer of Pfizer.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”

A bivalent vaccine mixes two vaccines, targeted at different versions of a virus, into one shot.

If the FDA authorizes the use of the booster, distribution could begin “immediately.” The pharmaceutical company says the shot would be available for those ages 12 and older.

Widespread availability would begin as soon as this fall, ahead of the expected winter surge of the virus, Bourla said in a statement.