The Baltimore plant hired to make Johnson & Johnson’s Covid-19 vaccine dirty, did not follow proper manufacturing procedures and had poorly trained staff, which led to contamination of the material in a batch of photographs, they said. said US regulators on Wednesday.
The Food and Drug Administration has issued a 13-page statement and report detailing the findings of its completed inspection only at the Emergent BioSciences plant.
Agency inspectors said a batch of bulk drugs for J & J’s single-command vaccine was contaminated with material used to make Covid-19 vaccines for another emerging customer, AstraZeneca. The batch, enough to make about 15 million doses of J&J vaccine, had to be discarded.
Other issues cited in the inspection report included peeling paint, black and brown residue on the floors and walls of the factory, inadequate cleaning and non-compliant employees to prevent contamination between vaccine batches and ingredients.
Nothing was distributed from the factory to J&J, the FDA said. The nearly 8 million doses of J&J vaccine given in the United States came from Europe.
Both Emergent and Johnson & Johnson said on Wednesday that they are working to fix the problems as soon as possible.
After the quality problems appeared at the end of last month, J&J took control of the factory. The Biden administration is now working to move the manufacture of the AstraZeneca vaccine to another factory. AstraZeneca has not yet applied for emergency permits for the use of its vaccine in the United States
The Baltimore plant shut down all production at the end of last week, at the request of the FDA. The Agency did not grant the factory the emergency approval that is required before the vaccine material manufactured there can be distributed.
All bulk vaccines from the Emergent plant, plus early batches made there and then put into vials and packaged by other J&J contractors, are stored and will be subjected to additional testing by the FDA, the agency said.
“We are doing everything we can to make sure that the Covid-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and efficacy,” the FDA said.
The use of the J&J vaccine is currently pending in the United States, as government health officials are investigating its possible link to very rare blood clots. Their decision to allow its resumption could come on Friday.
On Tuesday, the safety committee of the European Medicines Agency concluded that blood clots are a very rare side effect, but that the benefits of the vaccine outweigh this risk.
Emergent, a contractor little known for making drugs, has been given a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for issues ranging from poorly trained employees to cracked bottles and molds around one of its facilities, according to records obtained by The Associated Press.
After the J&J vaccine batch was contaminated, FDA inspectors began inspecting the Emergent plant on April 12 and completed the investigation on Tuesday.
Inspectors also reviewed security camera footage, which showed employees carrying bags of medical waste sealed in the factory, with bags touching materials ready to be used to make batches of vaccines.
The images also showed employees moving between the manufacturing areas for the two vaccines without documenting whether they changed protective clothing and went between them, as well as removing protective clothing from the warehouse next to the ingredients prepared for the vaccine, dropping clothes on the floor and then throwing in the trash cans.
The report noted that Emergent did not sufficiently investigate the contamination of the subsequently discarded J&J batch and did not appear to have done any further cleaning after it was discovered.
“There is no assurance that other batches have not been subjected to cross-contamination,” the report said.
He noted other problems at the factory, known as Bayview: inadequate vaccine procedures meet all quality and purity requirements, and floors and walls are too damaged to be properly sanitized. Also, the facility was too small and not properly designed for thorough cleaning, maintenance and operations, inspectors said.
It is not clear how long it will take companies to solve all the problems.
J&J is committed to delivering 100 million doses to the United States by the end of May and 1 billion doses globally by the end of the year.
“At this time, we cannot speculate on any potential impact it could have on the timing of our vaccine deliveries,” J&J said in a statement.