Vaccinators across the country are reporting weeks-long delays in shipping Moderna’s updated COVID-19 vaccine boosters. The delay comes after the Food and Drug Administration raised concerns at a facility contracted to fill the modern new injectables into vials.
Waiting stems from in Indiana a plant operated by Catalent, which is one of two companies bottling Moderna’s vaccine in the US
After inspection, FDA this month blamed contractor Moderna for failing its quality control procedures and failing to “thoroughly investigate” batches found to be contaminated. Since September 2020, the company has received 179 complaints about impurities in the bottles.
The FDA’s inspection tied emergency use approval to all updated doses filled and completed by Catalent for Moderna.
However, citing “potential supply constraints”, Moderna submitted additional data to the regulator asks to be cleaned 10 batches of his vaccine from Catalent’s factory. FDA approved that request on Tuesday.
“This approval is based on the FDA’s determination that the batches meet all applicable specifications, after careful review of the information Moderna submitted about the production of these batches. The agency has no concerns about the safety, efficacy or quality of these batches,” FDA spokesman Michael Felberbaum said in announcement.
News of the FDA’s move was first reported The Washington Post.
Moderna did not respond to multiple requests for comment.
The delays resulted in the smooth introduction of the updated boosters as they were formally approved for use September 1st.
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 any vaccine, “regardless of which primary vaccine they received.”
“We expect that Moderna’s supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available nationwide,” an HHS spokesperson said.
A Pfizer spokesman said the company had shipped “more than 21 million doses,” covering 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 Kalamazoo, MI site alone currently produces 10-15 million doses per week with the capacity to increase this significantly,” said Julia Michelle Cohen, Pfizer spokeswoman.
Nationwide data on how many doses of the vaccine have been delivered are expected to be released this Thursday, a Centers for Disease Control and Prevention official said at a recent webinar host of the COVID-19 Vaccine and Equity Project.
The agency’s first figures have been published last week suggested vaccinations climbed to their highest levels since early May as updated boosters began to roll out.
The FDA’s move also comes as the regulator said it is working to verify data submitted by Moderna, as well as Pfizer and its partner BioNTech to update booster doses for younger children.
In planning documents shared with health departments this weekThe CDC said it expects the bivalent shots could soon be approved for use in “early to mid-October” for younger age groups.
Moderna’s shots could be a simpler option for family doctors and pharmacies, as the company plans to use the same vials of vaccine as adults for children up to six years old.
“One question I’ll answer right away that might come up is, when are we going to have these vaccines for younger children? And I think we can say that for ages five and older, it’s a few weeks,” said Dr. Peter Marks of the FDA at a virtual event with the National Foundation for Infectious Diseases at Monday.
“And for the youngest kids, it’s probably later this fall to early winter as the data comes in and we can review it,” Marks said.