U.S. regulators said Wednesday the Baltimore plant contracted to contaminate Johnson & Johnson’s COVID-19 vaccine, did not follow proper manufacturing procedures and had poorly trained personnel.
The Food and Drug Administration released a 13-page statement and report outlining the findings of the recent inspection of the now vacant Emerging BioSciences Factory.
The agency’s inspectors said a large amount of drug material for J & J’s single-vaccine vaccine was contaminated with material used to make COVID-19 vaccines for another emerging customer, AstraZeneca. The group, which was allegedly enough to make about 15 million doses of J&J vaccine, had to be discarded.
Other problems cited in the inspection report are paint, black and brown residue on floors and walls in the factory, inadequate cleaning and employees who did not follow procedures to prevent contamination.
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.
Production stopped
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. The AstraZeneca vaccine has not yet been approved 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.
All of the largest vaccine Emergent has made, plus early quantities made there and then placed in vials and packaged by other J&J contractors, is stored and will be additionally tested by the FDA, the agency said.
“We are doing everything in our power to ensure that the COVID-19 vaccines given to the people of this country have met 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 the vaccine can be approved can come Friday. The factory inspection is not related to the continuous evaluation.
The European Medicines Agency’s safety committee said on Tuesday that its review had blood clot is a very rare side effect, but that the benefits of the J&J 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.
Potential for pollution
FDA inspectors began inspecting the Emergent plant in Baltimore on April 12 and completed their investigation Tuesday.
The inspectors checked the footage from the security camera which showed how workers carry unsealed bags of medical waste in the factory, with the bags of material ready to be used to make vaccine groups. The footage also showed employees moving between the two vaccines between the production areas without documenting whether they change protective coats and shower in between.
The inspection report noted that Emergent did not adequately investigate the contamination of the later disposable J&J bundle and apparently did no additional cleaning work after the contamination was discovered.
“There is no assurance that other groups have not been subjected to cross-contamination,” the report said.
It also noted that the factory had inadequate procedures to ensure that the vaccine met all quality and purity requirements.
It is unclear how long it will take the companies to solve all the problems in the factory, known as Bayview.
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.
“We are currently unable to speculate on the potential impact this could have on the timing of our vaccine delivery,” J&J said in a statement.