Pfizer and BioNTech announced Monday that they have submitted a bivalent COVID-19 booster to the Food and Drug Administration for emergency use authorization for people ages 12 and older.
The updated vaccine formula is targeted to provide protection against both the original COVID-19 virus from 2020 and omicron subvariants BA.4 and BA.5 following a recommendation from the FDA in June to develop boosters targeting newer subvariants of the omicron strain.
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“In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus,” BioNTech CEO and co-founder Ugur Sahin said.
If approved, it would be the first booster targeted toward the newer omicron subvariants. As of Monday, the omicron subvariant BA.5 accounted for 88% of all COVID-19 cases in the U.S., according to the Centers for Disease Control and Prevention.
The Biden administration has previously said it is keen to provide updated boosters to the public beginning in early to mid-September, though doing so is contingent on the FDA giving the green light and a recommendation from the CDC.
In anticipation of a fall rollout, the Department of Health and Human Services has secured agreements with Moderna and Pfizer to purchase approximately 171 million bivalent vaccine doses.
Preclinical data from Pfizer and BioNTech showed that the booster provided “strong” protection against the omicron subvariants.
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The United Kingdom became the first country to approve a dual-strain vaccine earlier this month from Moderna that targets the original COVID-19 virus and the first omicron strain, known as BA.1, as a booster for adults ages 18 and older.
