Peeling paint, unsanitary practices among problems in US factory to manufacture J&J COVID-19 vaccine -FDA

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By Carl O’Donnell and Julie Steenhuysen

(Reuters) – A U.S. facility that made Johnson & Johnson (NYSE 🙂 COVID-19 vaccine is facing a long list of problems, including peeling paint and unsanitary conditions and practices around the Resume operations Food and Drug Administration.

Experts said it could take months to address the issues raised in the damning FDA inspection report.

Neither J&J nor the FDA has announced when vaccine production will resume at the Emergent Biosolutions (NYSE 🙂 Inc. facility in Baltimore. Currently, only one plant produces the key compound used in J & J’s vaccine, the company told Reuters via email.

“These changes can take many months to be made,” said Prashant Yadav, a global healthcare supply chain expert at the Center for Global Development. He described some of the issues raised by the FDA as “quite significant”.

J&J said it would exercise its regulatory authority to ensure that all FDA observations are promptly and comprehensively addressed.

The 12-page report described dirty facilities and workers moving garbage near manufacturing areas. Problems were not investigated, cleanup was superficial and facility was not big enough, she added, describing crowded rooms.

“Patches of paint have been observed on the floor along the sides of these walls,” said one section of the corridors surrounding the manufacturing room, and “brown debris” on the wall and “black debris” on the floor in a technical room .

The healthcare company has been scrutinizing its stopping process for months in an effort to ramp up production of the one-shot vaccine, which is easier to manage and use than other approved vaccines.

Use in the US has been suspended since last week as health officials investigate a possible link to a very rare but serious blood clot disease.

Emergent has filed for regulatory approval to manufacture the J&J vaccine in the United States. Production at the factory recently stopped and the FDA asked it to do so after an inspection.

“What is important is that the FDA discovered these deficiencies” and took steps to ensure that the vaccine made there is not used, said vaccine researcher Dr. Anna Durbin from Johns Hopkins University in Baltimore.

“Emergent has some work to do to clean up their process. They will likely need to be re-examined by the FDA before any vaccine made there is accepted,” she said.

J & J’s facility in Leiden, the Netherlands, still produces cans for the world.

Johnson & Johnson reiterated Wednesday that it was working to build a global supply chain that would have 10 manufacturing facilities involved in the manufacture of its COVID-19 vaccine, in addition to the Leiden facility.

The company has entered into a US government-brokered agreement with competing drug maker Merck & Co as it prepares to manufacture doses of J & J’s vaccine.

ERRORS IN STAFF TRAINING

According to the inspection report, in addition to a personal on-site visit to the Emergent plant, the FDA team checked the footage from the surveillance cameras.

It was found that staff could not be trained to avoid cross-contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca (NASDAQ :), also manufactured on site. The agency also cited workers who carried unsealed bags of medical waste around the facility and placed them in contact with containers of material used in its manufacture.

Earlier this week, the U.S. House of Representatives opened an investigation into whether Emergent had used his relationship with a Trump administration official to obtain a contract to manufacture vaccines, despite reports that contracts were not being met.

Emergent said in a statement that it is working with the FDA and J&J to quickly resolve the issues described in the report.

Production of the AstraZeneca vaccine, which is not yet approved in the US, was previously halted at the Emergent facility after ingredients from that shot contaminated a batch J&J vaccine and ruined millions of doses.

The FDA also noted that Emergent did not provide adequate reports showing that the vaccines it manufactured met quality standards.

The inspection, which was conducted between April 12 and April 20, also found that the building was not the appropriate size or construction to facilitate proper cleaning, maintenance or operation.

J&J said it would redouble its efforts to get approval for the facility as soon as possible.

J & J’s oversight could help Emergent better address FDA concerns, none of which are particularly difficult to resolve, Cantor Fitzgerald analyst Brandon Folkes said in a note.

No vaccine manufactured at the Baltimore facility has been distributed for use in the United States.

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