The Trump administration has also deployed a handful of Pentagon personnel to integrate into the plant’s Emerging quality control section. They are still there today.
At one point in February 2021, Emergent accidentally mixed active ingredients for J & J’s vaccine with those for AstraZeneca’s vaccine, said two people familiar with Emergent’s operations. One of those people said the batch of Emergent failed a test at the end of the month and the company sent the 15 million doses to J & J’s facility in the Netherlands for testing. additional. J&J performed a series of additional tests which confirmed the contamination. Biden officials said they only learned of the contaminated doses in the last week of March.
The FDA has cited Emergent several times over the years for its poorly trained staff and for combating mold and contamination at its facilities. After its April 2020 inspection of the Emergent Baltimore plant, the agency cited the company for problems with its training of employees handling an experimental anthrax vaccine. The FDA said the company “has failed to train employees” in the particular operations they perform in their job and in current good manufacturing practices, “according to the Associated Press. A person familiar with the FDA investigation said the agency’s quote was the lowest warning issued by the FDA.
Trump and Biden officials say there is little the federal government could have done to help Emergent speed up recruitment and quality control around the production of Covid-19 vaccines. Although the government has helped fund the development and testing of J & J’s projectile, it has no control over the operations of the Emergent plant or how the company manages its internal inspection units.
Since the news of the batch contamination broke, J&J has said it will dedicate additional staff and resources to the Emergent plant which will be working 24/7 on the issue. “Specifically, the company adds dedicated operations and quality leaders, and dramatically increases the number of manufacturing, quality and technical operations staff to work with the business specialists already at Emergent,” according to a recently released press release by J&J.
It is not known how many additional J&J staff have been assigned to the Baltimore plant in recent days.