Emerging CEO Robert Kramer apologized at a Congressional hearing Wednesday for problems at the company’s Baltimore plant that resulted in the contamination of a batch of vaccine earlier this year.
Emergent attributed some of the problems to the need to produce two large-scale Covid-19 vaccines, which the company said has strained the capacity of its equipment. The factory also manufactured AstraZeneca AZN 0,39%
Covid-19 vaccine from PLC.
Emergent described some of the problems and its plan to address them in a letter to the U.S. Food and Drug Administration, responding to the agency’s findings of various deficiencies during an inspection in April.
A subcommittee of the US House Committee on Oversight and Reform released the April 30 letter ahead of its hearing on Emergent.
Emergent was producing a key bulk vaccine ingredient for Johnson & Johnson’s Covid-19 vaccine, but an accident led to the contamination of material that could have given up to 15 million doses in January and February.
The contamination came from viral material similar to that used in the production of the AstraZeneca vaccine at the same plant, according to a note from Democratic House committee staff to members.
The incident ruined J&J’s batch of vaccine ingredients and resulted in production of the J&J vaccine being stopped, as well as the decision to relocate production of AstraZeneca’s vaccine elsewhere. In addition, J&J took over the manufacturing of the Emergent plant.
At the hearing, Kramer said the company agreed last year with the federal government to manufacture the J&J and AstraZeneca vaccines, although the plant has not previously produced vaccines at full capacity.
“The increase in production of two new vaccines on a very large scale at the same facility is unprecedented,” he said in a remote online testimony.
Inspection of the Emergent factory by the FDA found that it was not maintaining conditions of cleanliness and hygiene and had not taken appropriate measures to avoid contamination. The inspection found that the building and equipment, including refrigerators, were not large enough to support large-scale manufacturing in a way that would ensure clean conditions.
Emergent, in its April 30 response, said, “The sudden surge towards large-scale manufacturing activities for two different Covid-19 vaccine drugs has strained the capacity of Emergent’s refrigerators.”
The company said it cleaned and organized them and would purchase additional refrigerators.
The company also said that its plant “saw a dramatic increase in demand for storage and warehousing as the facility was operating at full capacity for the first time. The company said it had changed procedures to mitigate the risk of contamination.
During the hearing, Democratic committee members generally criticized Emergent for the contamination issue. Rep. James Clyburn (D., SC), who is chairman of the House special committee on the coronavirus crisis, said the destruction of millions of doses of J&J vaccine was “due to Emerging’s inability to maintain its facilities, to adequately train its personnel and to ensure that the appropriate protocols have been followed. “
Several Republican members of the committee, however, defended Emergent. Rep. Mark Green (R., Tenn.) Said that Emergent had successfully delivered drugs and vaccines for other illnesses, including overdose treatment. Speaking to Mr Kramer, he said: “You are a reputable company that has done the job of yeoman to protect this nation through biodefense.”
Emergent, based in Gaithersburg, Md., Said in a statement Wednesday that its role in responding to the Covid-19 pandemic is “unlike anything we’ve faced before.” The company said it was focusing on releasing a vaccine ingredient that is currently under evaluation and resuming vaccine production.
The House committee also released documents showing that Emergent billed the federal government $ 27 million per month in reservation fees to be ready to manufacture vaccines.
The government has paid Emergent $ 271 million of these fees to date, but has partially stopped payment since learning of the contamination, Democratic committee staff said in the memo to members.
Write to Peter Loftus at [email protected]
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