U.S. regulators said Wednesday that the Baltimore plant hired to help make Johnson & Johnson’s Covid-19 vaccine was dirty, did not follow proper manufacturing procedures and had poorly trained staff. .
The Food and Drug Administration released a 13-page statement and report outlining the findings of the recently completed inspection of the idle Emergent BioSciences factory.
The agency’s inspectors said a batch of bulk medicines for J & J’s single-vaccine vaccine was contaminated with material used to make Covid-19 vaccines for another emerging customer, AstraZeneca. The group, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.
Other problems cited in the inspection report include paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine groups and ingredients.
Nothing manufactured in the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the US come from Europe.
Both Emergent and Johnson & Johnson said Wednesday that they are working to resolve the issues as quickly as possible.
After quality problems arose late last month, J&J took over the factory. The Biden administration is now moving AstraZeneca vaccine production to another factory. AstraZeneca has not yet requested emergency permission to use its vaccine in the US
The Baltimore plant stopped production late last week at the request of the FDA. The agency did not give the factory emergency permission, which is necessary before any vaccine made there can be distributed.
The agency stored all the major vaccine in Emergent’s factory, plus early quantities made there and then placed in vials and packaged by other J&J contractors, and will be additionally tested by the FDA.
“We are doing everything in our power to ensure that the Covid-19 vaccines given to the people of this country meet the high standards of the Agency for Quality, Safety and Efficiency,” the FDA said.
Currently, the use of the J&J vaccine in the US is being suspended while government health officials are investigating the possible link with very rare blood clots. They decide whether to resume use can come Friday.
The European Medicines Agency’s safety committee on Tuesday concluded that blood clots are a very rare side effect, but that the benefits of the vaccine outweigh the risks.
Emergent, a little-known drug manufacturing contractor, has played a key role in the Trump administration’s response to the coronavirus. According to FDA, the FDA has been repeatedly cited for problems ranging from poorly trained employees to burst vials and mold around one of the facilities.
After the J&J vaccine group became infected, FDA inspectors began investigating the Emergent factory on April 12 and completed their investigation on Tuesday.
The inspectors also checked the footage from the security camera, which shows workers carrying unsealed bags of medical waste around the factory, with the bags touching material ready to be used to make vaccines.
The footage also showed workers moving between the production areas for the two vaccines without documenting whether they change protective coats and showering in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothes on the floor and then throw it in open bins.
The report notes that Emergent did not adequately investigate the contamination of the later discarded J&J bundle and apparently did no additional cleaning work after it was discovered.
“There is no assurance that other groups have not been subjected to cross-contamination,” the report said.
Other problems in the factory, known as Bayview, have been noted: inadequate procedures to insure the vaccine meet all quality and purity requirements, and floors and walls are too damaged to be properly cleaned. The plant was also too small and not properly designed for thorough cleaning, maintenance and work.
It is unclear how long it will take the businesses to solve all the problems.
J&J has promised to deliver 100 million doses to the US by the end of May and 1 billion doses worldwide by the end of the year.
“At this time, we can not speculate on the potential impact this could have on the timing of our vaccine delivery,” J&J said in a statement.