Vaccine Plant for J&J to Stay on Hold After FDA Inspection
(Bloomberg) -- Production at an Emergent BioSolutions Inc. facility in Baltimore that’s expected to help make Johnson & Johnson’s coronavirus vaccine will remain on hold, U.S. regulators said, after an inspection turned up multiple problems.
The U.S. Food and Drug Administration said in a report posted on its website Wednesday that Emergent failed to thoroughly investigate unexplained discrepancies, including the cross-contamination of a vaccine substance batch with ingredients from another shot.
Emergent’s facility also lacked sufficient oversight and conditions were unsanitary, the agency said. Output at the plant has been on hold amid the inspection, which began last week and concluded on Tuesday.
Use of the J&J vaccine has been paused in the U.S. since last week as regulators probe reports that a small number of people suffered serious blood-clotting side effects after receiving the shot. The FDA said the Emergent report was unrelated to a safety review that the agency and the Centers and Disease Control and Prevention are conducting. An advisory panel is meeting Friday to weigh whether use of the vaccine should resume.
The FDA said in a statement that already-manufactured vaccines will undergo additional testing and evaluation to ensure their quality before they are distributed. The agency said that no vaccine manufactured at the plant has been distributed for use in the U.S.
In response to the findings, J&J said in a statement that it planned to set up a global supply network to produce its shots, and that it would ensure that the concerns raised by the FDA about the Emergent plant are addressed.
Emergent spokesman Matt Hartwig said the FDA findings will give the manufacturer direction on steps needed to improve operations and strengthen the J&J vaccine supply chain. Emergent makes the underlying drug substance used in the shot.
“While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them,” he said.
Last month, Emergent staff conflated materials for the J&J vaccine with another from U.K. drugmaker AstraZeneca Plc that was also being made on the premises. The error led the site to discard 15 million doses worth of an ingredient used in the J&J vaccine. J&J said on April 3 it would boost oversight of the facility and bring in new leadership.
“There is no assurance that other batches have not been subject to cross contamination,” the FDA inspectors wrote in their report.
Shares of both Emergent and J&J were down about 0.2% at noon in New York trading.
A Biden administration official, speaking in a briefing call ahead of a Wednesday speech by the president about the pandemic, said the inspection and subsequent remediation process is unfolding properly.
The Biden administration has taken an approach to securing and distributing vaccines that ensures it’s not overly dependent on any individual production facility or vaccine, the official said, noting the U.S. has enough vaccines for all willing and eligible adults by the end of May.
FDA inspectors found that containers where the drug substance was stored weren’t handled properly to prevent cross contamination, including instances caught on security cameras where employees dragged unsealed bags of special medical waste from manufacturing areas to the warehouse.
Cameras caught employees who removed outer protective garments and put them in open garbage containers in the warehouse where raw materials sat awaiting manufacturing, according to the FDA report.
Inspectors also flagged improper gowning procedures when employees who had been in a processing area for one bulk drug substance entered rooms where other substances were being made.
The FDA began an inspection at the Baltimore facility on April 12. Four days later, regulators requested that Emergent stop making new materials and quarantine existing materials until the inspection and any remediation are concluded.
Inspectors observed peeling paint, paint flecks on the floor and walls, and brown residue on the wall.
FDA inspectors determined the facility is too small to handle the waste being generated by its vaccine output. Security-camera footage showed Emergent’s warehouse overcrowded with materials awaiting manufacture and quality sampling.
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