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The U.S. Food and Drug Administration (FDA) announced Wednesday that it has approved a new coronavirus booster shot targeting the highly contagious omicron variant.
“Today, the U.S. Food and Drug Administration amended the Emergency Use Authorizations (EUAs) for the Moderna COVID-19 vaccine and the Pfizer BionTech COVID-19 vaccine to allow the use of at least two bivalent formulations of the vaccine as one booster dose. , months after primary or booster vaccination,” the statement said.
The new shot, which the FDA calls an “updated booster,” contains “two messenger RNA (mRNA) components of the SARS-CoV-2 virus. One of the strains and the other is a common strain, between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2.”
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“COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious consequences of COVID-19 (hospitalization and death),” FDA Commissioner Robert Calif said in a statement. . “As we head into the fall and start spending more time indoors, all eligible individuals should consider receiving a booster dose with the bivalent COVID-19 vaccine to provide better protection against the currently circulating variant. I highly recommend it to anyone.”
According to the FDA, the updated Moderna single-dose booster is approved for individuals age 18 and older, while the Pfizer-BioNTech booster is approved for individuals age 12 and older.
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Both types of booster shots offer “better protection against COVID-19 caused by the Omicron variant,” it added.
“The Omicron variant BA.4 and BA.5 strains currently cause most cases of COVID-19 in the United States and are projected to be epidemic this fall and winter,” the FDA said.
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The FDA also announced it would “work expeditiously to evaluate future data and submissions to support the approval of bivalent COVID-19 boosters for additional age groups.”
“FDA is planning the potential need to modify the composition of the COVID-19 vaccine to address the variants that are circulating,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We sought input from outside experts on including Omicron components in our COVID-19 boosters to provide better protection against COVID-19. We have worked closely with vaccine manufacturers to ensure development is safe and efficient.”