FDA Approves Bivalent COVID-19 Vaccines from Moderna and Pfizer/BioNTech

August 31, 2022

The US Food and Drug Administration (FDA) has approved both bivalent COVID-19 vaccine boosters from Moderna and Pfizer/BioNTech. The boosters contain spike pro mRNA from the original SARS-CoV-2 virus and the BA.4/BA.5 omicron strains currently dominant worldwide. The approval comes as the agency waits for more human data to come in.

According to Zachary Brennan, “To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) at least 3 months after the first booster dose. After 28 days, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.”

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(Source: endpoints News, August 31st, 2022)

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