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FDA releases more doses of Moderna’s updated Covid-19 boosters amid reports of ‘limited’ supply



CNN

The US Food and Drug Administration has authorized the release of “numerous batches” of Moderna’s updated Covid-19 booster amid reports of delivery problems in some areas.

Updated boosters from Pfizer/BioNTech and Moderna were made available early this month, shortly after the FDA approved them. However, some pharmacy chains have reported problems keeping Moderna’s shots in stock.

“Government offerings of the updated Moderna COVID-19 booster are currently limited, so product agreements may vary by country,” Walgreens said Tuesday. “The updated Pfizer COVID-19 booster remains available.”

Rite Aid said on Tuesday, “We have received limited supplies of the Moderna COVID-19 booster and expect to receive additional supplies in the coming weeks. We are actively working to increase inventory of COVID-19 boosters and have adequate stock of Pfizer-updated boosters in all stores.”

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FDA spokesman Michael Felberbaum said Tuesday that when the agency approved the updated boosters, it was in the midst of an inspection of a facility where the Moderna booster is made, and so “FDA has not listed this facility as an authorized manufacturing facility for the updated COVID-19.” -19 -19 vaccine booster at that time.” At that time, only Moderna batches from another facility were made available.

But on Tuesday, the agency said it had determined that “numerous batches” of the Moderna booster made at the first facility met the criteria for distribution “after a careful review of information provided by Moderna about the production of The agency is not concerned about the safety, effectiveness, or quality of these batches,” Felberbaum said.

Moderna said it is still on track to deliver 70 million doses of its updated vaccine by the end of 2022.

“We are working closely with the US government to provide significant quantities of updated bivalent booster doses as we continue to see high demand in certain parts of the country,” the company said. “We expect these availability restrictions to be resolved in the coming days.”

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Uptake of Covid-19 vaccine boosters was low long before the updated boosters were available. To date, less than half of the people in the US who received their first series and qualify for a booster — and less than a third of the total population — had received their booster shot.

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The federal government has not released data on how many people received the new injections, but the authorization of the updated boosters may have prompted more people to roll up their sleeves. Federal health officials have urged people to get an updated Covid-19 booster when they get a flu shot this fall, and the government recently launched an ad campaign targeting people 50 and older.

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