The FDA report describes Emergent’s vaccine plant as “overcrowded” and “clogged,” leading to piles of different materials close together and difficulty navigating the floor without bumping into equipment. Inspectors also saw paint peeling on walls and floors and improper decontamination of waste in the facilities.
Emergent said it is working with the FDA and J&J to quickly resolve the issues. “While we are never satisfied with shortcomings in our manufacturing facilities or our process, they can be corrected and we will take swift action to remedy them,” the company said in a statement.
It added that “the publication of findings by the FDA is normal after a facility inspection and provides guidance on necessary steps to improve operations.” But it’s rare for the agency to act so quickly – publishing a report on an inspection completed just a day earlier – and accompanying its findings with a statement from top FDA officials.
Johnson & Johnson is relying on Emergent to help achieve its goal of delivering 100 million doses to the federal government by June, although pressure to produce has eased since the company’s use of the company’s vaccine in the U.S. has been interrupted for a -related probe in rare but serious blood clots. J&J also enlisted pharmaceutical giant Merck to help produce vaccine substance, but Merck’s manufacturing facility won’t be ready to help until the second half of the year.
A second Merck plant on board to fill vials of the J&J vaccine and complete the packaging doses is unlikely to go into production without deliveries of Emergent’s vaccine substance, a person aware of the situation said. The person and another familiar with the FDA process said it could take months for some of these issues to be resolved.
In a statement, Johnson & Johnson said it would work to address the issues identified in the FDA inspection report and that it would continue to seek an emergency license for Emergent that would allow the company to produce J & J’s vaccine. .
But J&J also announced that it is in the process of establishing a “global vaccine delivery network” with a manufacturing site in Leiden, the Netherlands, which already produces Covid-19 vaccine substance, as well as ten additional unnamed manufacturing sites.
“We are working around the clock to develop and broadly activate our manufacturing capabilities to deliver our COVID-19 vaccine globally,” the company said.
The FDA released its latest inspection report just a day after investors said they would sue Emergent for not previously disclosing manufacturing issues leading to the ingredient mix ruining 15 million J&J shots. Federal regulators ordered AstraZeneca to leave Emergent’s plant in March, citing manufacturing errors.
The agency also inspected Emergent’s facilities in February and October, but it is unclear whether the extent of these issues was outlined in previous reports.
The FDA “takes its responsibility to take the quality, safety and effectiveness of medical products very seriously,” Acting Commissioner Janet Woodcock and Peter Marks, the vaccine chief, said in a joint statement. “The American public trusts the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety, and effectiveness.”
FDA, which said it will work with Emergent to resolve the issues, will have to re-inspect the plant and broadly test the batches before the doses are released for release.
Woodcock and Marks said in their statement that all doses already manufactured undergo additional testing, but are not yet clear for release. Doses made by Emergent are not authorized for emergency use, so none have been used by the public.