Two top executives at Emergent BioSolutions, the manufacturing plant that had to toss 15 million doses of Johnson & Johnson's COVID-19 vaccine after mixing it up with ingredients of AstraZeneca's vaccine, testified before Congress May 19 on the company's COVID-19 contracts and manufacturing processes.
Five takeaways from their testimony:
- Emergent CEO Robert Kramer told the House panel that the plant could resume manufacturing Johnson & Johnson's vaccine within a matter of days. He said the company has been working with the FDA and is close to correcting all of the issues cited by the agency, The Hill reported.
"We have made significant progress against all of those commitments, we are very close to completing them, and I would expect we would be in a position to resume production within a matter of days," he said.
- There are more than 100 million doses of Johnson & Johnson's vaccine on hold at the facility waiting for FDA approval. The FDA is conducting additional testing on the doses after finding multiple safety violations at the Emergent plant, CNBC reported.
An FDA spokesperson told CNBC: "We are working closely with the companies for whom products were manufactured in order to come to resolution on the disposition of the products." - Emergent officials blamed the government for not being prepared to handle the COVID-19 pandemic and enlisting the company to help produce vaccines on short notice, Politico reported. They also blamed AstraZeneca for sending flawed manufacturing processes that required them to make 80 process changes.
"It was very difficult, very complicated, and it did result in the number of lost production lines," Mr. Kramer told the panel, according to Politico.
But lawmakers argued that Emergent had received multiple warnings about its potential manufacturing issues before the 15 million vaccine doses were ruined. They said Emergent should have been better prepared, especially after the FDA flagged the issues, Politico reported.
In June 2020, when Emergent was awarded the contract, the federal government identified "significant risks" at the plant concerning staffing and compliance, NPR reported. Ten months later, the FDA found that staff training was still an issue.
- Mr. Kramer acknowledged in his testimony that there were unsanitary conditions, including mold, at the plant, and that staff was inadequately trained, according to The Hill.
Some employees at the plant failed to shower or change clothes, which is required when working in the facility and likely played a part in the spoiling of the vaccine doses, according to a memo released by the House, CNBC reported.
Inspections conducted last year also found problems with mold, poor disinfection of equipment and inadequate employee training.
"No one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine. I apologize for the failure of our controls," Mr. Kramer said, according to The New York Times. - Fuad El-Hibri, founder and chairman of Emergent, denied that the relationship between the company and Robert Kadlec, former assistant secretary for preparedness and response under former President Donald Trump, was responsible for Emergent being awarded the $628 million contract by the federal government, The Hill reported.
"This is simply not true," Mr. El-Hibri told the panel. "Emergent’s relationship with Dr. Kadlec was appropriate. And Emergent’s contracts with the U.S. government, including those associated with the COVID-19 response, have all been subject to standard government contracting procedures, overseen by independent career government contracting officers."