Updated COVID-19 booster shots aimed at providing immunity to variantsCertified Pediatric Nurse Practitioner Mallory Gray draws up a dose of Pfizer-BioNTech COVID-19 vaccine during DeKalb Pediatric Center’s vaccine clinic on May 12, 2021. On May 10, 2021 the U.S. Food and Drug Administration expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents age 12 through 15. Photo by Dean Hesse.
Update: The CDC approved the recommendation on Sept. 1. Here is our earlier story…
Atlanta, GA — On Wednesday, Aug. 31, the United States Food and Drug Administration authorized updated COVID-19 booster doses from Pfizer and Moderna for the first time since the vaccines received emergency use authorization.
The booster doses are bivalent vaccines that combine Pfizer and Moderna’s original vaccine with one that targets the Omicron variant, CNN reported.
The shots can be administered after they are recommended by the Centers for Disease Control and Prevention, which is set to occur on Thursday. Then the CDC director has to sign off on the recommendation, according to CNN.
“The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant,” a press release from the FDA states.
The FDA authorized the updated boosters for use as a single dose at least two months following primary or booster vaccination. The updated Moderna vaccine is authorized for individuals 18 and older, and the updated Pfizer vaccine is authorized for those 12 and older.
Individuals too young to receive an updated booster will still be able to be boosted with the earlier vaccine, CNN reported.
“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 FDA has been planning for the potential of modifying the vaccines to address circulating variants, said Peter Marks, M.D., Ph.D., 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. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” Marks said. “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.”
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