As the federal government scrambled to secure vaccine manufacturing capacity during the early days of the pandemic, it entrusted Emergent with a mammoth task — producing both Johnson & Johnson’s and AstraZeneca’s vaccines at its Baltimore facility. The company’s stock price soared on the announcement of a $628 million federal contract and on additional deals with the two drugmakers worth a combined $656 million.
But the documents released by the House investigators show that some of Emergent’s own managers feared the company was not up to the task.
In advance of a visit to the plant by F.D.A. officials in September 2020, a senior quality director warned executives that it would be critical to convince the agency that rapid improvements were underway. “We are not in full compliance yet- BUT- we are making batches NOW,” the director wrote.
In November 2020, one outside consultant to Emergent wrote that the firm’s manufacturing deficiencies constituted “a direct regulatory risk.”
During the September visit, the agency noted deficiencies. When officials returned in February 2021, Emergent employees sought to hide potential problems, according to the House report.
Previously, Emergent had placed yellow tags on containers holding part of a batch of Johnson & Johnson’s vaccine that was suspected to have quality problems. But employees removed the tags shortly before the F.D.A. visit and put them back on after the agency officials had left. Senior managers and an executive vice president of the company were aware of those actions, the House report found.
In an email obtained by the committee, an outside consultant to Emergent wrote that the purpose of removing the tags appeared to have been to “avoid drawing attention” to the potentially problematic containers.
House investigators wrote that “despite this apparent attempt to impede oversight,” the F.D.A. still identified serious quality concerns, but granted Emergent some leniency. In late March 2021, Emergent notified the Department of Health and Human Services about the contaminated doses. That set off a series of events that culminated with the Biden administration terminating Emergent’s vaccine production contract in November 2021.