More than 10 million doses held back by the the U.S. Food and Drug Administration as a result of a safety inspection at a packaging plant in Indiana should soon become available nationwide, The Washington Post reported.
No issues were found at the plant, the newspaper reported, and FDA spokesman Michael Felberbaum said in a statement to the newspaper that the agency authorized the “distribution of numerous batches” of the updated vaccine Tuesday that were manufactured there.
“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,” Felberbaum told the Post.
Safety inspectors started raising concerns about production at the Indiana plant, including that “the facility was not sufficiently sterile,” and checked to see if vials packaged there may have been contaminated, the Post reported, citing “people with knowledge of the inspection.”
A spokesman for the plant operator, Catalent, Chris Halling, said in a statement to the newspaper that, “A recent FDA inspection at our Bloomington facility resulted in observations that Catalent is already addressing, as it seeks to continuously improve its operations. Production at the facility has continued without interruption.”
Moderna told the Post it is “working closely” with the government to deliver additional doses of its updated COVID-19 booster vaccine amid “high demand” in some parts of the country.
“We anticipate that these availability constraints will be resolved in the coming days,” Moderna spokesman Chris Ridley said. “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.”
Some states, including California, Arizona and Pennsylvania, as well as chain pharmacies like CVS and Walgreens that receive a separate distribution of COVID-19 vaccines from the federal government, have run into shortages of the new Moderna booster shots,
That hasn’t been the case in Utah, said Rich Lakin, the Utah Department of Heath and Human Services’ immunization director.
“All the doses we have ordered have been received by providers,” Lakin said. “We are waiting for our next allocation (from the federal government) to submit orders.” He said he doesn’t yet know when the state will place a new order for doctors, local pharmacies, health departments and others giving the shots.
Utah initially ordered more than 100,000 doses of the new booster vaccines from the federal government.
Both Moderna and Pfizer booster shots, the first to be reformulated to target the COVID-19 omicron subvariants BA.4 and BA.5 that are currently circulating, were authorized by the government at the end of August for those who received their initial vaccination series or a booster dose at least two months ago.
People must be at least 18 to receive Moderna’s updated booster, while Pfizer’s is available to those as young as 12.
Other than the age requirement, the new Pfizer and Modern booster shots are “interchangeable,” Lori Abeyta, a clinical specialist with Intermountain Healthcare, recently told the Deseret News. “There’s no preference between one over the other. They should just get the one that they’re able to easily attain.”