Vaccinators across the country are reporting weeks-long delays in shipments of updated COVID-19 vaccine boosters from Moderna. The delays come after the Food and Drug Administration flagged concerns at a facility contracted to fill vials with Moderna’s new injections.
The wait stems from an Indian plant operated by Catalent, which is one of two companies that have been bottling Moderna’s vaccine in the US.
After an inspection, fda this month blamed Moderna’s contractor for failing to adhere to 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 its vials.
The FDA inspection had attached the emergency use authorization of all updated doses filled and terminated by Catalent for Moderna.
However, citing “potential supply constraints,” Moderna submitted additional data to the regulator. asking for clarification 10 batches of your vaccine from the Catalent plant. fda granted that request on Tuesday.
“This authorization was based on the FDA’s determination that the lots met all applicable specifications, after a careful review of the information provided by Moderna on the manufacture of these lots. The agency has no concerns about the safety, efficacy or quality of these batches”. FDA spokesman Michael Felberbaum said in a statement.
News of the FDA move was first reported by washington post.
Moderna did not respond to multiple requests for comment.
The delays have resulted in an unbalanced implementation of the updated boosters since they were formally authorized for use. On September 1.
A spokesman for the Department of Health and Human Services says that 26 million doses of the updated vaccines have been distributed. Americans are eligible to receive either vaccine, “regardless of which primary vaccine they have received.”
“We anticipate that Moderna’s supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is now widely available across the country,” the HHS spokesperson said.
A Pfizer spokesman said the company has supplied “more than 21 million doses,” which is 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 manufactures 10 to 15 million doses per week with the capacity to increase this considerably,” said Julia Michelle Cohen, a Pfizer spokeswoman.
Nationwide data on how many shipped doses of vaccine have gone into weapons is expected to be released Thursday, an official with the Centers for Disease Control and Prevention said at a recent meeting. webinar organized by the COVID-19 Vaccine and Equity Project.
The first figures of the agency published In the past week suggested vaccines rose to the highest levels since early May, when the updated boosters began rolling out.
The FDA move also comes as the regulator has said it is working to review data submitted by Moderna, Pfizer and partner BioNTech on updating booster shots for younger children.
In planning documents shared with health departments this weekthe CDC said they hope the bivalent injections could soon be licensed for use “from early to mid-October” for younger age groups.
Moderna’s injections could be an easier option for family doctors and pharmacies, since the company plans to use the same vials of vaccines as adults for children up to six years old.
“One question that I’m going to answer right now, that may come up is, when are we going to have these vaccines for younger kids? And I think we can say that, for the age range of five and up, that’s a couple of within a few weeks,” FDA’s Dr. Peter Marks said at a virtual event with the National Foundation for Infectious Diseases on Monday.
“And for younger kids, it’s probably later this fall or early winter when the data comes in and we can review it,” Marks said.