The Trump administration also deployed a handful of Pentagon personnel to integrate them into the Emergent QA section of the plant. They are still there today.
Sometime in February 2021, Emergent accidentally mixed the active ingredients in J & J’s vaccine with those in AstraZeneca’s vaccine, two people familiar with Emergent’s operations said. One of those people said that Emergent’s batch failed a test at the end of the month and the company shipped the 15 million doses to J & J’s facility in the Netherlands for further testing. J&J conducted a series of additional tests that confirmed the contamination. Biden officials said they did not learn of the contaminated doses until the last week of March.
The FDA has cited Emergent multiple times over the years for poorly trained staff and managing mold and contamination at its facilities. Following its April 2020 inspection of Emergent’s Baltimore plant, the agency cited the company for problems with training employees handling an experimental anthrax vaccine. The FDA said the company “failed to train employees’ in the particular operations they perform as part of their role and current good manufacturing practices,” according to The Associated Press. A person familiar with the FDA investigation said the agency’s citation was the lowest-level warning the FDA gives.
Both Trump and Biden officials argue that there is little the federal government could have done to help Emergent increase hiring and quality control around Covid-19 vaccine production. Although the government has helped finance the development and testing of J & J’s injection, it has no control over operations at the Emergent plant or how the company manages its internal inspection units.
Since news of the batch contamination broke, J&J has said it will dedicate additional staff and resources to the Emergent plant that will work 24 hours a day, 7 days a week on the issue. “Specifically, the company is adding dedicated operations and quality leaders, and significantly increasing the number of manufacturing, quality and technical operations staff to work with the company’s specialists already at Emergent,” according to a statement recently released by J&J.
It’s unclear how many additional J&J employees have been assigned to the Baltimore plant in recent days.