Vaccinators across 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 reported concerns at a facility contracted to fill Moderna’s new vaccines into vials.
Waiting comes from an indiana plant operated by Catalent, which is one of two companies bottling Moderna’s vaccine in the United States
Following a check, the FDA this month blamed Moderna’s contractor for failing to follow its quality control procedures and failing to “thoroughly investigate” batches found to be contaminated. Since September 2020, the company had received 179 complaints about impurities in its bottles.
The FDA inspection had blocked the emergency use authorization of all updated doses filled and completed by Catalent for Moderna.
However, citing “potential supply limitations”, Moderna submitted additional data to the regulator. ask to delete 10 batches of its vaccine from the Catalent factory.
The FDA granted this request on Tuesday. Moderna told the regulator it plans to “submit similar applications for additional batches on an ongoing basis” to release millions more doses.
“This clearance was based on the FDA’s determination that the lots met all applicable specifications, after careful review of information provided by Moderna on the manufacture of these lots. The agency has no safety concerns, efficacy or quality of these batches,” FDA spokesman Michael Felberbaum said in a statement.
News of the FDA’s decision was first reported by The Washington Post.
“We expect these availability constraints to be resolved in the coming days. We continue to be on track to meet our commitment to deliver 70 million doses of our updated bivalent vaccine by the end of this year. “said Moderna spokesperson Christopher Ridley. A declaration.
Chris Halling, 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 is continued without interruption”.
“Catalent takes all submissions very seriously, and we have already begun taking all necessary steps to respond to each submission as quickly as possible,” Halling said.
The delays have resulted in an unbalanced rollout of updated boosters since they were officially cleared for use September 1.
A spokesperson for the Department of Health and Human Services said 26 million doses of the updated vaccines have been distributed. Americans are eligible to receive either vaccine, “regardless of the primary vaccine they received.”
“We anticipate that Moderna’s supply will continue to increase in the days and weeks ahead. Pfizer’s updated COVID-19 vaccine is already widely available across the country,” the HHS spokesperson said. .
A Pfizer spokesperson said the company has supplied “more than 21 million doses”, equivalent to about 80% of the US supply so far. The company plans to ship “up to 100 million” doses by the end of November.
“Pfizer’s location in Kalamazoo, Michigan alone is currently manufacturing 10 to 15 million doses per week with considerable capacity to scale up,” said Julia Michelle Cohen, a spokeswoman for Pfizer.
National data on the number of vaccine doses shipped that went through the arms is expected to be released this Thursday, a Centers for Disease Control and Prevention official said in a recent online seminar organized by the COVID-19 Vaccine and Equity Project.
The first figures of the agency published Last week suggested vaccinations hit the highest levels since early May as updated boosters began rolling out.
The FDA decision also comes as the regulator said it was working to verify data submitted by Moderna as well as Pfizer and its partner BioNTech on the booster shot update for young children.
In planning documents shared with health services this weekthe CDC said it expects bivalent injections will soon be cleared for use “early to mid-October” for younger age groups.
Moderna’s vaccines could be a simpler option for family doctors and pharmacies, given that the company plans to use the same vaccine vials as adults for children up to six years old.
“A question that I’m going to answer right away, that might arise, is when are we going to have these vaccines for young children? And I think we can say that, for the five-year-old age group and more is a few in a few weeks,” FDA’s Dr. Peter Marks said during a virtual event with the National Foundation for Infectious Diseases. On Monday.
“And for younger kids, it’s probably later this fall into early winter when the data is coming in and we can look at it,” Marks said.