The Baltimore factory hired to make the Johnson & Johnson COVID-19 vaccine dirty, did not follow proper manufacturing procedures and had poorly trained staff, which would cause contamination of the material that would be fired, they said Wednesday U.S. regulators.
The Food and Drug Administration issued a 13-page statement and report detailing the findings of its recent inspection of the now dormant BioSciences Emerging Factory.
Agency inspectors said a batch of bulk pharmaceuticals for J & J’s unique vaccine was contaminated with material used to make COVID-19 vaccines for another emerging customer, AstraZeneca. That batch, according to reports, was enough to make about 15 million doses of J&J vaccine, had to be expelled.
Other problems mentioned in the inspection report were peeling paint, black and brown debris on the floors and walls of the factory, inadequate cleaning and employees not following the procedures to prevent contamination.
Nothing manufactured at the factory has been distributed to J&J, the FDA noted. The nearly eight million doses of J&J vaccine administered in the U.S. came from Europe.
Both Emergent and Johnson & Johnson said Wednesday they are working to fix the problems as quickly as possible.
After quality issues surfaced late last month, J&J took control of the factory. The Biden administration is now working to move the manufacture of AstraZeneca vaccines to another factory. AstraZeneca vaccine is not yet authorized in the US
The Baltimore factory stopped all production late last week at the request of the FDA. The agency has not given emergency approval to the factory, which is needed before any vaccine material manufactured there can be distributed.
All the bulk vaccine substance that Emergent has manufactured is being stored, in addition to the first batches that were manufactured there and introduced into vials and packaged by other J&J contractors, which will be subjected to additional testing by the FDA, the agency said.
“We are doing everything we can to ensure that COVID-19 vaccines that are administered to people in this nation meet the agency’s high standards of quality, safety, and effectiveness,” the FDA said.
At the moment, the use of the J&J vaccine is on hold in the United States, as government health officials are investigating its possible connection to very rare blood clots. His decision on whether to allow the administration of the vaccine could come on Friday.
On Tuesday, the safety committee of the European Medicines Agency said its review found that blood clots are a very rare side effect, but that the benefits of the J&J vaccine outweigh that risk.
Emergent, a little-known drug manufacturing contractor, was given a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and molds around one of its facilities, according to records obtained by The Associated Press.
FDA inspectors began reviewing the Baltimore Emerging Factory on April 12 and ended the investigation Tuesday.
Inspectors reviewed images from security cameras showing employees carrying bags of unsealed medical waste at the factory, with the bags touching materials ready to be used to make batches of vaccines. The images also showed employees moving between the manufacturing areas of the two vaccines without documenting whether they changed protective gowns and showered in the middle, as needed.
The inspection report noted that Emergent did not sufficiently investigate the contamination of the discarded J&J batch later and did not appear to have done any additional cleaning after the contamination was discovered.
“There is no guarantee that other batches have not been subject to cross-contamination,” the report stated.
It was also noted that the factory had inadequate procedures to ensure that the vaccine substance met all quality and purity requirements.
It is unclear how long it will take companies to solve all the problems of the factory, known as Bayview.
J&J is committed to providing 100 million doses for the United States by the end of May and 1 billion doses worldwide by the end of the year.
“At this time, we cannot speculate on any potential impact this may have at the time of delivery of the vaccines,” J&J said in a statement.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.