The Trump administration also deployed a handful of Pentagon employees to embed them in Emergent’s quality control space. They are still there today.
Sometime in February 2021, Emergent accidentally mixed ingredients for J & J’s vaccine with those for AstraZeneca’s shot, said two people familiar with Emergent’s operations. One such employee said the batch of Emergent failed a test at the end of the month and the company sent the 15 million cans to J & J’s Netherlands office for further testing. J&J performed a number of additional tests that confirmed the contamination. Biden officials said they didn’t find out about the contaminated cans until the last week of March.
The FDA has cited Emergent several times over the years for poorly trained personnel and how to deal with mold and contamination in their facilities. After inspecting the Emergent Baltimore facility in April 2020, the agency led the company over problems training staff to handle an experimental anthrax vaccine. The FDA said the company “failed to train employees on the specific operations they perform as part of their role and current good manufacturing practice.” according to The Associated Press. One person familiar with the FDA’s investigation said the agency’s quote was the lowest warning the FDA is handing out.
Both Trump and Biden officials argue that there was little the federal government could have done to help Emergent improve attitudes and quality control in making Covid-19 vaccines. While the government helped fund the development and testing of the J&J shot, it has no control over the operations at Emergent’s facility or how the company operates its internal inspection units.
Since the news of the batch contamination was released, J&J has announced plans to add additional staff and resources to the Emergent facility, which will be working on the issue around the clock. “Specifically, the company is adding dedicated operations and quality executives and significantly increasing the number of manufacturing, quality and technical operations people who work with the corporate specialists already at Emergent,” said a recently released statement from J & J.
It is unclear how many additional J&J employees have been assigned to the Baltimore plant in the past few days.