Authorization for Bivalent Omicron Boosters

Insider sources say that the US Food and Drug Administration could authorize the new bivalent COVID-19 vaccines from Moderna and Pfizer/BioNTech as early as Labor Day, September 5^th. The vaccines contain mRNA for spike protein from the BA.4/BA.5 SARS-CoV-2 that currently dominating worldwide and the spike protein from the original strain from 2019 and early 2020.

According to Berkeley Lovelace Jr., “The FDA’s authorization will not be the final step before the shots can be distributed. The CDC must also sign off; the agency plans to convene its advisory panel, the Advisory Committee on Immunization Practices, on Sept. 1 and 2 to discuss Covid boosters, according to the agency.”

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(Source: NBC News, August 23^rd, 2022)