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

By Karma Hasan and Catherine Dillinger | CNN

The US Food and Drug Administration has cleared the release of “multiple batches” of Moderna’s updated Covid-19 booster amid reports of supply issues in some areas.

Updated boosters from Pfizer/BioNTech and Moderna were made available earlier this month, soon after the FDA cleared them. However, some drugstore chains have reported problems keeping Moderna in stock.

“Government supplies of the updated Moderna COVID-19 booster are currently limited, resulting in varying product appointments across the country,” Walgreens said Tuesday. “Updated Pfizer COVID-19 booster remains available.”

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

FDA spokesman Michael Felberbaum said Tuesday that when the agency authorized the updated boosters, it was in the middle of an inspection of a facility where Moderna’s booster was manufactured, and thus “FDA did not include that facility as an authorized manufacturing facility for the updated COVID -19 booster vaccine at that time.” At this point, only Moderna batches from another facility were provided.

But on Tuesday, the agency said it had determined that “multiple batches” of the Moderna booster made at the first facility met the criteria for distribution “after a careful review of the information provided by Moderna about the production of these batches.” The agency has no concerns about the safety, effectiveness or quality of these batches,” Felberbaum said.

Moderna said it was 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 supply significant quantities of updated bivalent booster doses as we continue to see high demand in certain areas of the country,” the company said. “We expect these availability constraints to be resolved in the coming days.”