WASHINGTON – Johnson & Johnson vaccine was contaminated by ingredients from another company’s vaccine at a manufacturing plant in Baltimore, federal officials confirmed Wednesday, ruining a batch of raw vaccine representing millions of doses and prompting a review.
However, Johnson & Johnson said in a statement it was still on track to deliver the 20 million doses it promised the federal government by Wednesday and was on track to deliver another 24 million doses by the end of April.
The mixing of ingredients for coronavirus vaccines for Johnson & Johnson and AstraZeneca occurred at a plant operated byEmergent, which has not yet been certified by the Food and Drug Administration to produce Johnson & Johnson vaccine.
Emergent is a contract manufacturer for bulk vaccine substance for both Johnson & Johnson and AstraZeneca. It also has federal agreements for production of medicines to combat bioterror threats.
Emergent did not respond to requests for comment Wednesday.
Johnson & Johnson’s vaccine was granted emergency use authorization by the FDA in February. AstraZeneca, after a number of clinical trial problems, has not yet been authorized in the United States.
None of the contaminated vaccine made it out of the plant, a federal official said. It had not reached the “fill-and-finish”‘ stage of production, which involves final formulation and filling vials after bulk vaccineis shipped to a Catalent plant in Indiana.
“We are going to make sure that we understand what happened,” said a health official who spoke on the condition of anonymity because he was not authorized to discuss the situation. “We have to work through and find out what is going on.”
Johnson & Johnson provided no details in a statement but said it was beefing up staff and oversight of vaccine manufacturing at the plant.
It has been shipping raw ingredients from Europe pending certification of the Emergent facility.
“Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson coronavirus vaccine,” the company said in a statement.
The New York Times first reported the incident. It said about 15 million doses worth of bulk vaccine were ruined and said it was attributed to human error.
Johnson & Johnson did not confirm the estimate of volume that was ruined. But at Johnson & Johnson’s $10-a-dose price for the finished product, the value would be up to $150 million.
A federal official said the cross-contamination was caught on routine quality control checks by Johnson & Johnson. “The issue is whether manufacturing processes at the plant are suboptimal,” said the official. “Nothing got out of the plant.”
The discoverywas made a few days ago, setting off a flurry of meetings involving the Food and Drug Administration, Johnson & Johnsonand the Biomedical Advanced Research and Development Authority in the Department of Health and Human Services.