The Baltimore factory hired to help make Johnson & Johnson’s Covid-19 vaccine was dirty, did not follow proper manufacturing procedures, and had poorly trained personnel, resulting in contamination of material that ended up in a series of injections US regulators said Wednesday.
The Food and Drug Administration has released a statement and 13-page report detailing the findings of the just-completed inspection of the unused Emergent BioSciences plant.
Agency inspectors said a batch of the bulk drug for J & J’s single vaccine was contaminated with material used to make Covid-19 vaccines for another Emergent customer, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be discarded.
Other issues identified in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning, and workers not following procedures to avoid contamination between vaccine lots and ingredients.
Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the US came from Europe.
Both Emergent and Johnson & Johnson said on Wednesday that they are working to resolve the issues as quickly as possible.
After quality problems surfaced late last month, J&J took over the factory. The Biden government is now working to move production of AstraZeneca vaccines to another plant. AstraZeneca has not yet applied for an emergency permit for the use of its vaccine in the US.
The Baltimore plant ceased all production late last week at the request of the FDA. The agency has not given the factory emergency approval, which is necessary before the vaccine material made there can be distributed.
All bulk vaccine substances at Emergent’s plant, plus early batches made there and then bottled and packaged by other J&J contractors, will be stored and will undergo additional testing by the FDA, the agency said.
“We are committed to ensuring that the Covid-19 vaccines given to the people of this country meet the agency’s high standards for quality, safety and effectiveness,” said the FDA.
Currently, use of the J&J vaccine has been suspended in the US as government health officials are investigating the possible link to very rare blood clots. Their decision whether or not to resume its use could come Friday.
On Tuesday, the European Medicines Agency’s safety committee concluded that the blood clots are a very rare side effect, but that the benefits of the vaccine outweigh that risk.
Emergent, a little-known drug manufacturing contractor, was instrumental in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for issues ranging from poorly trained workers to cracked bottles and mold around one of its facilities, according to data obtained by The Associated Press.
After the batch of J&J vaccine was contaminated, FDA inspectors began checking the Emergent plant on April 12 and ended their investigation on Tuesday.
The inspectors also viewed images from security cameras, which showed workers carrying unsealed bags of medical waste around the plant, with the bags touching materials ready to be used to make batches of vaccines.
The images also showed that workers walked between the production areas for the two vaccines without documenting whether they changed protective coats and showered in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothing on the floor and then put it in the open trash cans.
The report noted that Emergent had not sufficiently investigated the contamination from the later discarded J&J batch and did not appear to have performed additional cleaning after it was discovered.
“There is no guarantee that other batches have not been subject to cross-contamination,” the report said.
It noted other problems at the plant known as Bayview: inadequate procedures to ensure the vaccine met all quality and purity requirements, and floors and walls too damaged to be properly disinfected. The plant was also too small and not well designed for thorough cleaning, maintenance and operations, inspectors said.
It is unclear how long it will take for the companies to resolve all issues.
J&J has pledged to provide 100 million doses to the US by the end of May and 1 billion doses worldwide by the end of the year.
“At this point in time, we cannot speculate about the potential impact this could have on the timing of our vaccine deliveries,” J&J said in a statement.