(Reuters) – A US facility that manufactured Johnson & Johnson's COVID-19 vaccine has to fix a long list of problems including color scaling and unhealthy conditions and methods to resume operations, according to a highly critical report by Food and Drug Administration.
Experts said addressing the issues raised in the difficult FDA inspection report could take months.
Neither the J&J nor the FDA have said when they expect vaccine production to resume at the Baltimore facility owned by Emergent Biosolutions Inc. Only one factory currently produces the main drug substance used in J & J's vaccine, the company said via e- mail to Reuters.
"It can take many months to make these changes," said Prashant Yadav, a global expert in the healthcare supply chain at the Center for Global Development. He described some of the issues raised by the FDA as "quite significant."
J&J stated that it will exercise its supervisory authority to ensure that all FDA observations are dealt with promptly and fully.
The described 1
"Paint stains were observed on the floor along the sides of these walls," in corridors surrounding the manufacturing room, it was stated in a section, adding that there was "brown residue" on the wall and "black residue" on the floor in a plant room.
The healthcare company has been reviewing for several months over its stop process to increase the production of the disposable vaccine that is easier to handle and use than other approved vaccines.
Its use in the United States has been suspended since last week when health officials investigate a possible link to a very rare but serious blood clotting condition.
Emergent has applied for permission to make the J&J vaccine in the United States. It stopped production at the factory recently and said the FDA had asked it to do so after an inspection.
"What is important is that the FDA captured these deficiencies" and took steps to ensure that the vaccine produced there was not used, the vaccine said. researcher Dr. Anna Durbin from Johns Hopkins University in Baltimore.
“Emergent has some work to do to clean up its process. They will probably need to be inspected again by the FDA before any vaccine produced there would be accepted, she says.
J & J's factory in Leiden, the Netherlands, still produces doses for the world.
Johnson & Johnson reiterated on Wednesday that they were working to establish a global supply chain where 10 manufacturing facilities would be involved in the production of their COVID-19 vaccine, in addition to the factory in Leiden.
The company has a US government mediated agreement with rival. the pharmaceutical manufacturer Merck & Co, which is preparing to make doses of J & J's vaccine.
The inspection report states that the FDA team had examined images of security cameras in addition to a personal visit to the Emergent facility.
to train staff to avoid cross-contamination of Johnson & Johnson and AstraZeneca COVID-19 vaccines, which had also been produced on site. The agency also cited personnel carrying unsealed bags of medical waste at the facility and brought them into contact with containers of materials used in manufacturing. administrative officer to obtain a vaccine manufacturing contract despite a record of not delivering a contract.
Emergent said in a statement that it is cooperating 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 for use in the United States, was previously stopped at the Emergent plant after ingredients from that shot contaminated a batch of J&J vaccine, destroying 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 was conducted between April 12 and April 20, also found that the building was not of the appropriate size or design to facilitate proper cleaning, maintenance or operation.
J&J said that it doubled its efforts to obtain a permit for the facility as soon as possible.
J & J's oversight can help Emergent better deal with the FDA's concerns, none of which are particularly difficult to fix, Cantor Fitzgerald's analyst Brandon Folkes said in a note.
No vaccine manufactured in the Baltimore plant has been distributed for use in the United States.