A US factory that made Johnson & Johnson’s (JNJ.N) COVID-19 vaccine must resolve a long list of problems, including paint peeling and unsanitary conditions and practices to resume surgery, according to a highly critical report by the Food and Drug Administration.
Experts said it could take months to address the issues raised in the FDA’s damning inspection report.
Neither J&J nor the FDA have said when they expect vaccine production to resume at the Baltimore facility owned by Emergent Biosolutions Inc (EBS.N). Only one plant currently produces the main drug used in J & J’s vaccine, the company told Reuters by email.
“It could take many months to implement these changes,” 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 will exercise its supervisory authority to ensure that all FDA observations are promptly and fully addressed.
The 12-page report described dirty facilities and workers transporting waste near production areas. Problems were not investigated, cleanups were superficial, and the facility was not large enough, it added, describing overcrowded rooms.
‘Paint stains were observed on the floor along the sides of these walls’, in hallways surrounding the production area, he said in a section, adding that there was ‘brown residue’ on the wall and ‘black residue’ on the floor in a technical room .
The healthcare company has spent months focusing on the discontinuation process to scale up production of the one-time vaccine that is easier to handle and use than other authorized vaccines.
Its use in the United States has been on hold since last week as health officials are studying a possible link to a very rare but serious blood clot disorder.
Emergent has filed for legal permission to make the J&J vaccine in the United States. It recently stopped production at the plant and said the FDA had asked it to do so after an inspection.
“What’s important is that the FDA has noticed these shortcomings” and has taken steps to ensure that the vaccine produced there was 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-inspected by the FDA before any vaccine produced there will be accepted,” she said.
J & J’s factory in Leiden is still producing doses for the world.
Johnson & Johnson reiterated on Wednesday that it was in the process of establishing a global supply chain in which 10 manufacturing sites would be involved in the production of the COVID-19 vaccine, in addition to the Leiden plant.
The company has a U.S. government-brokered agreement with rival drug company Merck & Co (MRK.N), which is preparing to make doses of J & J’s vaccine. read more
NO TRAINING STAFF
According to the inspection report, the FDA team had viewed images from security cameras in addition to a face-to-face visit to the Emergent plant.
It turned out that staff had not been trained to prevent cross-contamination from COVID-19 vaccines from Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L), which had also been produced on site. The agency also noted that staff carry unsealed bags of medical waste into the facility and put them in contact with containers of materials used in production.
Earlier this week, US house representatives launched an investigation into whether Emergent used his relationship with a Trump government official to secure a vaccine manufacturing contract, despite a track record of breaching contracts.
Emergent said in a statement that it is working with the FDA and J&J to promptly resolve the issues outlined in the report.
Production of the AstraZeneca vaccine, which has not yet been approved for use in the United States, was previously halted at the Emergent plant after ingredients from that shot contaminated a batch of J&J vaccine, ruining millions of doses.
The FDA also noted that Emergent did not produce adequate reports showing that the vaccines it produced met quality standards.
The inspection, which was conducted between April 12 and April 20, also revealed that the building was not of the correct size or design to allow for proper cleaning, maintenance or operations.
J&J said it redoubled its efforts to get approval for the facility as soon as possible.
J & J’s oversight could help Emergent better address the FDA’s concerns, which are not particularly difficult to resolve, Cantor Fitzgerald analyst Brandon Folkes said in a note.
There is no vaccine manufactured at the Baltimore facility distributed for use in the United States.
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