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US FDA authorizes Pfizer and Moderna’s updated COVID-19 boosters targeting omicron subvariants

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

The US Food and Drug Administration (FDA) granted emergency use authorization for updated COVID-19 vaccine booster shots from Moderna and Pfizer on Wednesday.

Both jabs are bivalent vaccines that combine the companies’ original vaccine with one that targets the BA.4 and BA.5 omicron subvariants dominating the US, CNN and The Washington Post report.

The boosters are scheduled to be reviewed by Centers for Disease Control and Prevention (CDC) advisers on Thursday.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical. 
    
“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. 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. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

For each of the bivalent COVID-19 vaccines authorized today, the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. Furthermore, data pertaining to the safety and effectiveness of the current mRNA COVID-19 vaccines, which have been administered to millions of people, including du

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