Recent articles in trade publications and The Washington Post have attributed a delay in the release of millions of Moderna COVID-19 booster shots to a safety inspection at the Catalent plant in Bloomington.
According to The Post's Sept. 20 article, the Food and Drug Administration inspection focused on production issues at the plant that bottles and packages the vaccine.
A copy of the redacted inspection report states that procedures "to prevent microbiological contamination of drug products purporting to be sterile" were not written or followed. The report was not a final FDA determination regarding compliance, but contained recorded observations made Aug. 27-Sept. 2.
Between Aug. 11, 2021, and April 7, 2022, some batches were released "after exceeding the supplemental visible particles testing," an FDA observer wrote.
In response, Catelent provided an FDA statement that said because the inspection at the Bloomington plant was "still ongoing when FDA authorized the updated Moderna booster, FDA did not include this facility as an authorized manufacturing facility for the updated COVID-19 vaccine booster at that time. The agency has no concerns with the safety, effectiveness or quality of these batches."
On Aug. 31 of this year, the FDA authorized booster shots from Moderna and Pfizer that target new omicron strains of the coronavirus.
In an email to The Herald-Times, Catalent Pharma Solutions spokesperson Chris Halling said that "during its recent routine inspection of our Bloomington facility, the FDA found no issues related to the safety or efficacy of the Moderna booster batches. Production at the facility, including COVID-19 vaccines, has continued without interruption. Nevertheless, Catalent takes all observations very seriously, and we have already begun employing all necessary steps to address each observation as quickly as possible."
Catalent has locations across the U.S. and in Europe, China, Japan, Brazil, Argentina and Canada. The Bloomington location has grown since it first took over the facility in October 2017. The company announced a $350 million expansion of the Bloomington facility in April with the goal of hiring 1,000 more workers.
This article originally appeared on The Herald-Times: Catalent Bloomington inspection affects Moderna COVID booster release