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September 08 2022

Updated COVID-19 Booster Shots

Earlier this week, the Food and Drug Administration (FDA) authorized the bivalent Pfizer-BioNTech and Moderna COVID-19 booster formulations of the vaccines for people ages 12 years and older. The bivalent vaccines are being referred to as “updated boosters.”

The updated Modera COVID-19 booster is authorized for individuals ages 18 years and older, while the updated Pfizer-BioNTech booster is authorized for individuals ages 12 years and older.

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations. 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.”

This new booster includes Omicron BA.4 and BA.5 spike protein in the vaccine composition. In a recent article, CNN Medical Analyst Dr. Leana Wen noted that this updated vaccine formula is not unusual, as it’s done every year with the flu vaccine.

The Center for Disease Control and Prevention (CDC) also recommended the shot, following FDA authorization, and has started the rollout process across the U.S. This updated COVID-19 booster replaces the previously offered shots. Anyone ages 12 years and older is now considered “up-to-date” after receiving the new COVID-19 booster.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” said CDC Director Rochelle P. Walensky, M.D., M.P.H. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The CDC recommends everyone ages 6 months and older receive the COVID-19 vaccine, and everyone ages 5 years and older receive a booster dose. This week’s news updates the guidance for people ages 12 years and older to receive the updated booster dose.

Sources:

“Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose.” FDA.GOV 31 August 2022.

“CDC Recommends the First Updated COVID-19 Booster.” Centers for Disease Control and Prevention. 1 September 2022.

“Who should get the updated coronavirus vaccine booster now—and who should wait?.” CNN. 8 September 2022.