Moderna Covid-19 booster shortage leads to fewer appointments in pharmacies

Some US pharmacies and other vaccine providers are only offering the new Covid-19 booster shot from Pfizer inc

and BioNTech SE,

after a manufacturing quality issue at a job shop caused a shortage of Moderna inc

new refresher shot.

In recent days, federal officials have informed state officials that there is a limited supply of Moderna’s updated booster shots, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

A Moderna spokesman said the company expects the restrictions issues to be resolved in the coming days. “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 areas of the country,” the spokesman said.

According to Moderna, the supply of his booster shot could improve within a few days.


Photo:

Hannah Beier for the Wall Street Journal

Some pharmacies and other vaccination sites have either canceled appointments or stopped making new appointments for people who wish to receive a Moderna booster shot. At CVS Health corp

some dispensaries have used up all of their Moderna booster shots and are continuing to offer Pfizer shots while they work to acquire more Moderna doses, a CVS spokeswoman said.

California-based health care system Kaiser Permanente is urging people to get the Pfizer boosters if they’d rather not wait for new shipments of Moderna’s shot, a spokesman said. The Lehigh Valley Health Network in Pennsylvania has stopped booking appointments for the Moderna booster as it awaits more doses and is offering the Pfizer vaccine, a spokesman said.

The Centers for Disease Control and Prevention has said adults can get a new, updated booster shot from either Pfizer or Moderna, regardless of which vaccine they received for their original series.

The supply crisis for Moderna marks an early stumble in the US campaign to roll out updated booster shots to tens of millions of people ahead of a possible spike in Covid-19 cases this fall and winter as people spend more time indoors.

The FDA has approved newly modified Covid-19 boosters to target the latest versions of the Omicron variant. But as WSJ’s Daniela Hernandez explains, an important part of the decision-making process has been changed with these new recordings. Photo: Laura Kammermann

Some people who have attempted to book appointments online to get the Moderna booster are being told there are no time slots available, said Dr. Plescia. If people try again and pick the Pfizer shot, they should be able to get appointments, he said.

Cambridge, Massachusetts-based Moderna said supplies of its booster vaccine could improve within days after the Food and Drug Administration this week approved the release of about 10 million doses that had been held up because of the production problem.

The company still expects to ship 70 million doses of its updated booster shot by the end of this year under the terms of a federal supply agreement, the Moderna spokesman said.

The FDA approved the use of new, updated booster shots from Moderna and Pfizer with their partner BioNTech in late August, designed to better target the latest versions of the Omicron variant of the coronavirus. The updated Moderna booster is legal for ages 18+ and the Pfizer BioNTech booster is legal for ages 12+.

New York-based Pfizer has shipped more than 21 million doses of its updated booster shot to the United States and plans to ship more than 100 million by the end of November, a spokeswoman said.

According to the CDC, about 4.4 million Americans have received an updated booster dose, which is about 2% of those who have completed a primary series.

The Moderna shortage came after the FDA conducted an inspection of a Catalent in August inc

Pharmaceutical plant in Bloomington, Indiana that fills and packages Moderna’s vaccine for distribution.

FDA inspectors found several potential violations of drug manufacturing standards at the Catalent plant, according to an inspection document the FDA released online this week. The inspectors said Catalent failed to properly investigate findings of visible particles in certain products. The report published online is partially redacted and did not make it clear which products were affected.

A Catalent spokesman said the FDA has not identified any issues related to the safety or efficacy of the Moderna booster lots. Production at the plant, including the Covid-19 vaccines, has continued without interruption. The company is taking steps to address the FDA inspection findings, the spokesman said.

However, as a result of the inspection, the Aug. 31 FDA approval for Moderna’s new booster vaccine did not include millions of doses manufactured at Catalent’s facility and they were not distributed. Prior to this week, the only Moderna cans distributed were made at a different facility.

Due to concerns about supply restrictions, Moderna asked the FDA to review some of the lots of its new booster shot that were being held at Catalent’s facility.

The FDA reviewed 10 batches — about 10 million doses in all — and found them eligible for clearance, according to a Sept. 20 letter from the FDA posted on its website. The FDA will consider releasing additional batches.

“This approval was based on FDA’s determination that the batches met all applicable specifications after carefully reviewing the information provided by Moderna regarding the manufacture of these batches,” said an FDA spokesman. “The agency has no concerns about the safety, efficacy or quality of these batches.”

Separately, Moderna said Friday it has asked the FDA to approve use of its updated booster shot in children ages 6 to 17. The company expects to complete an application to use the booster vaccine in children 6 months to 5 years later this year.

—Jared S. Hopkins contributed to this article.

Write to Peter Loftus at [email protected]

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