Posted by on September 21, 2022 5:43 pm
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FDA releases additional doses of Moderna’s COVID-19 booster amid shortages

A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore. on Dec. 27, 2021. Jenny Kane/AP

FDA releases additional doses of Moderna’s COVID-19 booster amid shortages

Abigail Adcox September 21, 04:59 PMSeptember 21, 04:59 PM Video Embed

The Food and Drug Administration is releasing additional doses of Moderna’s omicron-specific COVID-19 boosters that were previously withheld from the government’s initial rollout earlier this month while the agency conducted safety inspections at an Indiana packaging plant.

Ten batches of the new shots, equivalent to millions of doses, manufactured at a facility in Bloomington, Indiana, will go out for distribution as some providers report shortages of Moderna’s booster and instead offer Pfizer-BioNTech’s vaccine.

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“As part of our regulatory oversight work, the agency recently conducted an inspection at a Catalent manufacturing facility that was contracted by Moderna to produce batches of its updated COVID-19 vaccine booster. Because this inspection was still ongoing when FDA authorized the updated Moderna booster, FDA did not include this facility as an authorized manufacturing facility for the updated COVID-19 vaccine booster at that time,” the FDA said in a statement.

A recent inspection from the FDA as part of its “regulatory oversight work” raised concerns that the Indiana plant operated by Catalent, which helps bottle and package Moderna’s vaccine, was not adequately sterilized. The FDA has since determined that there were no issues with Moderna’s updated boosters, authorizing their release.

“The agency has no concerns with the safety, effectiveness, or quality of these batches,” the FDA added.

A spokesman for Catalent, Chris Halling, said that production has not been affected during the inspection process.

“A routine recent FDA inspection at our Bloomington facility resulted in observations that Catalent is already addressing, as it seeks to continuously improve its operations. Production at the facility has continued without interruption. We will respond to the FDA by the deadline,” Halling said.

Booster shots from Catalent’s plant had not been a part of the federal government’s rollout earlier this month after the FDA authorized the new shots by Moderna and Pfizer-BioNTech on Aug. 31. The U.S. secured 66 million doses of Moderna’s booster and 105 million of Pfizer-BioNTech’s earlier this year in anticipation of a fall booster campaign. Smaller quantities of Moderna’s updated booster, coupled with production delays, have led to some supply shortfalls in recent weeks.

Matt Blanchette, a spokesman for CVS, said that some of its pharmacies have run out of Moderna’s booster.

“We’re working with the government to acquire more Moderna doses and continue to offer Pfizer and limited Moderna appointments at CVS.com and via the CVS Pharmacy app. Appointments are updated as supply is received,” said Blanchette.

Walgreens has also reported similar issues, causing appointments for Moderna’s updated booster to vary across the country, said Stephanie Corcilius, a spokeswoman for Walgreens.

“We are currently working to reschedule some appointments where supply has been interrupted. The updated Pfizer COVID-19 booster remains available. We are not experiencing any impacts to the Pfizer product supply at this time,” said Corcilius.

Local health departments administering the shots have also experienced lower supply levels of Moderna’s updated booster. Floyd County Health Department in Indiana announced Tuesday that it has nearly exhausted all its supplies of Moderna’s booster and does not expect another shipment until the end of the month, encouraging people to get Pfizer’s booster in the meantime. Washington, D.C., reported earlier this month that doses of Moderna were back in stock at its COVID-19 centers after a temporary shortage.

Only 25 million of the over 170 million updated boosters the government purchased have been sent out so far, with the majority being Pfizer-BioNTech’s booster candidate, the Administration for Strategic Preparedness and Response told Reuters. The production delays are just another snag in the Biden administration’s booster campaign as it struggles to get people to opt in for the new shots.

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The updated booster recipe targets both the original strain of the virus from 2020 and omicron subvariants BA.4 and BA.5. People who are eligible to receive the updated booster can get either Pfizer-BioNTech’s or Moderna’s regardless of which manufacturer’s vaccine they previously received, though Moderna’s has only been authorized for people 18 and older, while Pfizer-BioNTech is approved for those 12 years and older.

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