Vaccinators around the country are reporting weeks-long delays in shipments of Moderna’s updated COVID-19 vaccine boosters. The delays come after the Food and Drug Administration flagged concerns at a facility contracted to fill the Moderna’s new shots into vials.
The wait stems from an Indiana plant operated by Catalent, which is one of two firms that has been bottling Moderna’s vaccine in the U.S.
Following an inspection, the FDA this month faulted the Moderna contractor for falling short in its quality control procedures, and failing to “thoroughly investigate” batches discovered to be contaminated. Since September 2020, the company had received 179 complaints over impurities in its vials.
The FDA’s inspection had tied up emergency use authorization of all the updated doses filled and finished by Catalent for Moderna.
However, citing “potential supply limitations,” Moderna submitted additional data to the regulator asking to clear 10 batches of its vaccine from Catalent’s plant.
The FDA granted that request on Tuesday. Moderna told the regulator it plans to “submit similar requests for additional batches on a rolling basis” to free up millions more doses.
“This authorization was based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of these batches,” FDA spokesperson Michael Felberbaum said in a statement.
News of the FDA’s move was reported first by The Washington Post.
“We anticipate that these availability constraints will be resolved in the coming days. We continue to be on track to meet our committed delivery of 70 million doses of our updated, bivalent vaccine by the end of this year,” Moderna spokesperson Christopher Ridley said in a statement.
Chris Halling, a spokesperson for Catalent, said the FDA had “found no issues related to the safety or efficacy of the Moderna product” during its routine inspection, adding that production of the vaccines “has continued without interruption.”
“Catalent takes all observations very seriously, and we have already begun employing all necessary steps to address each observation as quickly as possible,” Halling said.
The delays have resulted in a lopsided rollout of the updated boosters since they were formally cleared for use on September 1.
Some states have moved to suspend ordering for the Moderna doses, citing the delays. Others have urged residents not to wait for the Moderna shots.
A spokesperson for the Department of Health and Human Services says 26 million doses of the updated shots have been distributed. Americans are eligible to receive either shot, “regardless of which primary vaccine they received.”
“We anticipate that Moderna supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available across the country,” said the HHS spokesperson.
A spokesperson for Pfizer said the company has supplied “more than 21 million doses,” which works out to some 80% of the U.S. supply so far. The company plans to ship “up to 100 million” doses by the end of November.
“Pfizer’s Kalamazoo, MI site alone is currently manufacturing 10-15 million doses per week with capacity to increase this considerably,” said Julia Michelle Cohen, the Pfizer spokesperson.
Nationwide data on how many the shipped doses of vaccine have gone into arms is expected to be released this Thursday, a Centers for Disease Control and Prevention official said at a recent webinar hosted by the COVID-19 Vaccine and Equity Project.
Early figures from the agency posted last week suggested vaccinations climbed to the highest levels since early May, as the updated boosters began to roll out.
The FDA’s move also comes as the regulator has said it is working to vet data submitted by Moderna as well as Pfizer and its partner BioNTech on updating booster shots for younger children.
In planning documents shared with health departments this week, the CDC said it expects the bivalent shots could soon be cleared for use “in early to mid-October” for younger age groups.
Moderna’s shots could be a simpler option for family doctors and pharmacies, given the company plans to use the same vaccine vials as adults for children down to six years old.
“One question that I’ll answer right now, that may come up is, when are we going to have these vaccines for younger children? And I think we can say that, for the age range of five and up, that’s a couple of weeks away,” the FDA’s Dr. Peter Marks told a virtual event with the National Foundation for Infectious Diseases on Monday.
“And for the youngest children, it’s probably later this fall to early winter as the data come in and we can review it,” said Marks.