Vaccinators across the country are reporting weeks-long delays in shipments of Moderna’s updated COVID-19 vaccine booster. The delay comes after the Food and Drug Administration raised concerns about a facility contracted to fill Moderna’s new shots into vials.
The wait begins An Indiana The plant, operated by Catalent, is one of two companies bottling Moderna’s vaccine in the United States
Following an inspection, FDA This month Moderna blamed the contractor for failings in its quality control procedures and for failing to “thoroughly investigate” batches discovered to be contaminated. As of September 2020, the company has received 179 complaints for impurities in its vials.
FDA’s inspection was associated with emergency use approval of all updated doses filled and completed by Catalent for Moderna.
However, Moderna submitted additional information to the regulator, citing “potential supply constraints.” Asking to clean up 10 batches of vaccine from Catalent’s plant. FDA granted That request on Tuesday.
“This approval was based on FDA’s determination that the batches met all applicable specifications, after a careful review of the information provided by Moderna regarding the manufacture of these batches. The company has no concerns about the safety, efficacy or quality of these batches,” FDA spokesman Michael Felberbaum said in a statement. said
News of the FDA’s action was first reported by The Washington Post.
Moderna did not return multiple requests for comment.
The delay has resulted in a one-way rollout of updated boosters since they are officially cleared for use September 1.
Moved to some states Order suspended For Moderna dosage, delay cited. Others urged residents don’t wait For the Moderna shot.
A Department of Health and Human Services spokeswoman said 26 million doses of the updated shots have been distributed. Americans are eligible for any shot, “regardless of the primary vaccine they received.”
“We expect that Moderna supplies 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 Pfizer spokeswoman said the company has delivered “more than 21 million doses,” which works out to about 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 is currently producing 10-15 million doses per week, which has the capacity to grow substantially,” Pfizer spokeswoman Julia Michelle Cohen said.
Nationwide data on how many shipped doses of the vaccine have gone into arms are expected to be released this Thursday, a Centers for Disease Control and Prevention official said in a recent Web Seminar Hosted by the COVID-19 Vaccine and Equity Project.
Preliminary statistics from the Post Agency last week Recommended vaccinations climbed to the 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 examine data submitted by Moderna as well as Pfizer and its partner BioEntech on updating booster shots for young children.
In the planning document shared with the Department of Health this weekThe CDC said it expects the bivalent shots to be cleared for use in younger age groups as soon as “early October.”
While Moderna’s shots could be an easier option for family doctors and pharmacies, the company plans to use the same vaccine vials for children under six as adults.
“One question I would answer right now is, when are we going to give this vaccine to young children? And I think we can say that, for ages five and older, it’s a few weeks away,” said Dr. Peter of the FDA. Marks said at a virtual event with the National Foundation for Infectious Diseases on monday.
“And for the youngest kids, maybe after this fall the data comes in early winter and we can review that,” Marks said.
