(Bloomberg) — Some pharmacies are reporting shortages of Moderna Inc.’s new bivalent booster shot for COVID-19 as one factory used in producing the vaccine remains offline following a safety inspection.
The U.S. government supply of Moderna’s shot is currently limited, causing appointments for the product to vary across the country, a Walgreens Boots Alliance Inc. pharmacy spokesperson said in an emailed statement. Meanwhile, CVS Health Corp. says some of its drugstores have used all of the updated shots they received from the government, and the company is trying to get more doses.
Moderna has been coping without one of its vaccine-manufacturing facilities, which hasn’t been cleared by the Food and Drug Administration to make the new booster shots. The FDA said in a statement Tuesday it recently inspected a Catalent Inc. facility that contracted with Moderna to produce its shots.
Moderna tapped Catalent in June 2020 to fill and package its COVID vaccine at a Bloomington, Indiana, site. The FDA said that it would release some batches of Moderna’s vaccine made at the Catalent facility “following a careful review of information provided by Moderna about the manufacture of these batches.” The FDA hasn’t released any information on what inspectors found during the inspection.
“The safety of the American public is our top priority, and the FDA continues to work to ensure that batches of the updated Moderna COVID-19 vaccine, bivalent booster meet our expectations for safety, effectiveness and manufacturing quality,” the agency said in an emailed statement.
A Moderna spokesperson on Tuesday said the company is working closely with the U.S. government to deliver “significant amounts” of updated boosters amid “high demand in certain areas of the country.” Moderna expects the supply constraints to be resolved in the coming days and says it’s still on pace to deliver 70 million doses of its booster by the end of the year.
The shortage should be resolved in about two weeks, Arizona’s interim health director Don Herrington said in a blog post this week, citing information that the Centers for Disease Control and Prevention provided local health officials. A spokesperson for the CDC referred questions to the Department of Health and Human Services, which didn’t immediately respond to a request for comment.
New formulations targeting the original coronavirus strain and the omicron BA.4 and BA.5 variant started rolling out this month, testing Americans’ demand for another round of shots. Immunization rates have declined with every new booster offered.
Pharmacies aren’t seeing any supply issues with Pfizer Inc. and BioNTech SE’s updated COVID vaccine. Pfizer said it has shipped more than 21 million doses of its booster and plans to provide up to 100 million by the end of November.
As of Sept. 14, the U.S. government had made about 35 million booster shots available for states and jurisdictions to order, of which 30 million were Pfizer’s shot and 5 million were Moderna’s, according to emails sent to local health departments by HHS.
While Moderna “continues to ramp up production,” the government is adjusting ordering thresholds in coming weeks to focus supply on pharmacies, prioritizing locations that “cannot switch to Pfizer in the short term and need immediate resupply,” according to one of the emails that was reviewed by Bloomberg.
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