FDA Approves Pfizer and Moderna Bivalent Boosters

FDA has officially authorized new COVID-19 vaccine boosters from both Pfizer-BioNTech and Moderna. They contain two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2. These are authorized for individuals 12 and 18 years of age respectively.

The BA.4 and BA.5 lineages of the Omicron variant are currently causing most cases of COVID in the US and are predicted to circulate this fall and winter.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” says Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. "We sought input from our outside experts on the inclusion of an Omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently."