September 1, 2022

FDA authorizes updated COVID-19 booster vaccines

By: Lauren McCaffrey

Editor's Note

The Food and Drug Administration (FDA) authorized updated versions of the Moderna and Pfizer-BioNTech vaccines with the goal of protecting against the recent Omicron variant, NPR August 31 reports. The updated booster, called a bivalent vaccine, offers protection from both the original strain of COVID-19 and the most recent Omicron BA.4 and BA.5 subvariants.

According to the World Health Organization, nearly 80% of COVID-19 cases worldwide are caused by the BA.5 subvariant.

"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 have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently," said Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

The Moderna vaccine is authorized for a single booster dose in people 18 years and older, and the Pfizer-BioNTech booster is authorized for people 12 years and older. Two months after people complete the initial vaccination or booster shot, they are eligible for the new booster. The boosters will be available starting next week.

A day after the FDA cleared updated versions of the COVID-19 vaccines that incorporate protection against the later subvariants, the EU did the same. While new COVID-19 cases and deaths have been dropping globally, experts still expect a surge of hospitalization and deaths during the winter months.


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