Coronavirus: FDA OKs updated Moderna, Pfizer booster shots that target omicron

Officials with the Food and Drug Administration on Wednesday authorized the emergency use of updated booster COVID-19 vaccine doses developed by Moderna and Pfizer-BioNTech that target two omicron subvariants.

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The updated boosters protect broadly against the original strain of COVID-19 and specifically against subvariants that have recently accounted for a majority of new coronavirus infections nationwide, according to the FDA and the Centers for Disease Control and Prevention. The Moderna shots will be available to people aged 18 and older, while the shots developed by Pfizer and BioNTech will be available to people who are at least 12 years old. People are eligible for booster vaccines two months after they’ve been fully vaccinated or received their last booster dose.

The decision means that the new booster doses could become available nationwide in the coming days. Federal officials told NPR that they plan to make the shots available beginning next week. An influential CDC advisory committee is scheduled to meet Thursday to discuss recommending use of the boosters.

The shots target the BA.4 and BA.5 subvariants of the omicron virus, which accounted for more than 90% of the COVID-19 cases seen in the U.S. from the week beginning Aug. 21, according to the CDC.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that officials have been preparing for the possibility that COVID-19 vaccines would need to be updated to better protect against variants of the virus circulating nationwide. He said the FDA has been working with 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,” he 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.”

Officials from Modern, Pfizer and BioNTech asked the FDA to consider authorizing their newly formulated booster shots last week.

As last week, just over 79% of the U.S. population has gotten at least one dose of any of the available COVID-19 vaccines, according to the CDC. Over 67% of Americans have been fully vaccinated, and more than 48% of those who have been fully vaccinated have gotten at least one booster shot, CDC data shows.

Since the start of the pandemic, officials have confirmed more than 94.4 million COVID-19 infections and reported over 1 million deaths nationwide, according to numbers compiled by Johns Hopkins University. More than 602.4 million COVID-19 cases have been reported worldwide, resulting in 6.4 million deaths, according to the university.

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