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Report: FDA Considers Authorizing Another Round of Updated COVID-19 Booster Shots for Some

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The Food and Drug Administration is reportedly preparing a decision on whether another round of updated COVID-19 booster shots should be authorized for certain populations.

People familiar with the agency’s discussions told The Wall Street Journal that the decision, which would apply to the elderly and other Americans at high risk for severe COVID-19, could come within a few weeks.

The Wall Street Journal reported that the FDA is considering authorizing a second omicron-specific booster shot for people aged 65 and older or who have weakened immune systems. One source said that the decision is not yet final, noting that officials could change their minds.

An FDA spokesperson said in a statement to U.S. News that “we hope that simplifying the COVID-19 vaccine regimen in the not too distant future will lead to the vaccination of more individuals in the coming years as we learn to live alongside SARS-CoV-2 – potentially reducing serious outcomes, including hospitalization and death,” referring to the virus that causes COVID-19 by its scientific name.

“We continue to closely monitor the emerging data in the United States and globally, and we will base any decision on additional updated boosters upon those data,” the agency spokesperson said. “Importantly, individuals who have not yet received an updated (bivalent) booster are encouraged to speak with their health care provider and consider receiving one.”

While uptake of the updated booster so far has been low – just 16% of the U.S. population has rolled up their sleeves for the shot – some recipients are eager to get another boost.

The Biden administration has been eyeing a shift to an annual COVID-19 booster shot schedule to potentially begin in the fall. But the FDA previously acknowledged that “two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals).”

According to a recent survey from the Kaiser Family Foundation, 15% of all adults said they are waiting on the Centers for Disease Control and Prevention to issue new guidance on the next coronavirus shot. The CDC would have to recommend the shots after the FDA’s authorization for them to become widely available.

The developments come after health officials in Canada and the United Kingdom this month recommended another COVID-19 booster shot in the spring for people at high risk for severe disease.

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