After quietly withholding millions of Moderna’s newly formulated COVID-19 booster doses because of manufacturing issues at a Catalent factory in Indiana, the United States has reportedly released the shots.
The news comes after unexplained supply problems with the Moderna booster, which was authorized for use by the FDA on Aug. 31, the same day that the regulator also signed off on the COVID-19 booster by Pfizer.
On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent.
Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product.
The company also used equipment for purposes beyond its design. And the FDA pinged Catalent for failing to address customer complaints, which included 179 reports of particulate matter in drug vials.
"A recent FDA inspection at our Bloomington facility resulted in observations that Catalent is already addressing, as it seeks to continuously improve its operations," a Catalent spokesperson said in an emailed statement. "Production at the facility has continued without interruption."
The issue appears to have caused a hiccup for Moderna's updated booster rollout. In recent weeks, various reports have flagged shortages of the new vaccine. On Tuesday, the Washington Post reported that the supply issue was tied to the Catalent plant.
“We continue to see high demand in certain areas of the country,” a Moderna spokesperson told MarketWatch in an email. “We anticipate that these availability constraints will be resolved in the coming days.”
Catalent’s growth and scale up during the pandemic has been rapid. In April of this year, the company announced a $350 million expansion of the Bloomington facility to grow its capacity to produce and package drug products. The investment will eventually help create more than 1,000 jobs, the company said.
In November of 2021, Catalent also purchased three parcels of land just south of the Bloomington plant for $1.2 million to allow for the expansion, the company said.
Early in the pandemic, Catalent agreed to manufacture vaccines for both Moderna and Johnson & Johnson. The first sign of trouble at the Bloomington plant came in September of 2020, when the FDA cited (PDF) the company for a lack of procedures to prevent contamination.
The U.S. has been plagued by manufacturing problems surrounding the COVID-19 vaccine. At an Emergent facility in Baltimore, hundreds of millions of doses of AstraZeneca and J&J vaccines were discarded because of suspected cross contamination.