FDA grants Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for ages 12 years and older
Pfizer Inc. and BioNTech SE announced that the FDA granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older
An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to FDA in early October. The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.
The Omicron BA.4 and BA.5 subvariants together are the prevalent variants of concern in the U.S., prompting the FDA to instruct manufacturers to develop a variant-adapted vaccine that also addresses the spike protein of the Omicron BA.4/BA.5 subvariants. Pfizer and BioNTech’s bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical spike protein amino acid sequences, both can be targeted at once with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.