By Carl O’Donnell and Julie Steenhuysen
(Reuters) -A U.S. plant that was making Johnson & Johnson (NYSE:JNJ)’s COVID-19 vaccine must fix a long list of problems including peeling paint and unsanitary conditions and practices to resume operation, according to a highly critical report by the Food and Drug Administration.
Experts said addressing the issues raised in the scathing FDA inspection report could take months.
Neither J&J nor the FDA has said when they expect vaccine production to restart at the Baltimore plant owned by Emergent Biosolutions (NYSE:EBS) Inc. Only two other plants are currently equipped to supply the world with the key drug substance for J&J’s vaccine.
“It may take many months to make 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 oversight authority to ensure that all of the FDA observations are addressed promptly and comprehensively.
The healthcare conglomerate has drawn scrutiny for months over its halting process to scale up production of a vaccine that is easier to handle and, by virtue of being a single shot, easier to use than other authorized vaccines.
Its use in the United States has been paused since last week as health officials study a possible link to a very rare but serious blood clot condition.
Emergent has been seeking regulatory authorization to make the J&J vaccine in the United States. It stopped production at the plant recently, saying the FDA had asked it to do so after an inspection.
J&J’s plant in Leiden, the Netherlands, is still producing doses for the world. It has another facility in India, which is currently curtailing exports of the shot as it struggles to vaccinate its own population.
Johnson & Johnson reiterated on Wednesday that it was working to establish a global supply chain in which 10 manufacturing sites would be involved in production of its COVID-19 vaccine, in addition the Leiden plant.
The company has a U.S. government-brokered agreement with rival drugmaker Merck & Co, which is preparing to make doses of J&J’s vaccine.
FAILURE TO TRAIN PERSONNEL
The FDA in its final 12-page inspection report said it had reviewed security camera footage in addition to an in-person site visit to the Emergent plant.
It found failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca (NASDAQ:AZN), which had also been produced at the site. The agency also cited staff carrying unsealed bags of medical waste in the facility, bringing it in contact with containers of material used in manufacturing.
Earlier this week, the U.S. House Representatives launched an investigation into whether Emergent used its relationship with a Trump administration official to get a vaccine manufacturing contract despite a record of not delivering on contracts.
Emergent said in a statement that it is working with the FDA and J&J to quickly resolve the issues outlined in the report.
Production of the AstraZeneca vaccine, which is not yet authorized for use in the United States, was previously stopped at the Emergent plant after ingredients from that shot contaminated a batch J&J vaccine, ruining millions of doses.
The FDA also noted that Emergent did not produce adequate reports showing that the vaccines it was producing met quality standards.
The inspection, carried out between April 12 and April 20, also found the building not of suitable size or design to facilitate cleaning, maintenance or proper operations.
J&J said it was redoubling its efforts to get authorization for the facility as quickly as possible.
No vaccine manufactured at this plant has been distributed for use in the United States.
Peeling paint, unsanitary practices among issues at U.S. plant making J&J COVID-19 vaccine -FDA