Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 years and older.
And on the same day, Moderna, Inc. has also received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Omicron-targeting bivalent COVID-19 booster vaccine.
Moderna's updated, bivalent booster is expected to be available at vaccination sites nationwide in the coming days. Doses of Moderna's Omicron targeting booster vaccine have been purchased by the U.S. Government's Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological Nuclear Defense (JPEO-CBRND) and the Army Contracting Command
Pfizer will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 12 years of age and older are anticipated to start subject to and after the Centers for Disease Control and Prevention (CDC) endorse a potential recommendation by the Advisory Committee on Immunization Practices (ACIP). Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
Around 109 million people in the U.S. have received their first booster dose, according to the CDC, with about 23 million having received a second.
Public health experts are hoping the revamped vaccines will improve the nation’s booster rate, which has stagnated in recent months, The Wall Street Journal reports.
