A Johnson & Johnson contractor’s plant for producing coronavirus vaccines is not large or sanitary enough and the company has not resolved issues that led to the contamination of millions of doses, the Food and Drug Administration said in a report released Wednesday.
The findings from the agency’s inspection of Emergent BioSolutions, which took more than a week and prompted FDA to order the company to pause production, cast doubt on whether Emergent will be able to contribute to J&J’s vaccine-delivery goals in the months ahead.
Some of the issues FDA inspectors found — such as unsanitary conditions and quality control problems — could be resolved fairly quickly. But the agency’s conclusions about the size and design of Emergent’s manufacturing facilities will be harder to address, and could prevent the company from meeting its goal to deliver millions of doses of Covid-19 vaccines this year. Maryland-based Emergent had previously promised that between J&J and a since-canceled contract with AstraZeneca that it would produce one billion doses in 2021.
The FDA report describes Emergent’s vaccine plant as “overcrowded” and “congested” leading to stacks of different materials near each other and difficulties navigating the floor without bumping into equipment. Inspectors also noted peeling paint on walls and floors and improper decontamination of waste in the facilities.
Emergent said that it is working with FDA and J&J to resolve the issues quickly. “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,” the company said in a statement.
It added that “the issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations.” But it is rare for the agency to move so quickly —releasing a report on an inspection concluded just a day earlier — and to accompany its findings with a statement by top FDA officials.
Johnson & Johnson has been relying on Emergent to help reach its goal of delivering 100 million doses to the federal government by June, although the pressure to produce has lessened since use of the company’s vaccine is paused in the U.S. for an unrelated probe into rare but serious blood clots. J&J also enlisted pharmaceutical giant Merck to help with producing vaccine substance, but Merck’s manufacturing facility will not be ready to help until the second half of the year.
A second Merck plant on board to fill vials with the J&J vaccine and finish packaging doses is unlikely to start production without deliveries of vaccine substance from Emergent, said a person with knowledge of the situation. 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 problems identified in the FDA inspection report and would continue to seek an emergency authorization for Emergent that would allow the company to manufacture J&J’s vaccine.
But J&J also announced that it is establishing a “global vaccine supply network” that includes a manufacturing site in Leiden, Netherlands, that is already producing Covid-19 vaccine substance, we well as ten additional, unnamed manufacturing sites.
“We are working around the clock to develop and broadly activate our manufacturing capabilities to supply our COVID-19 vaccine worldwide,” the company said.
The FDA released its latest inspection report just a day after investors said they would sue Emergent for not previously disclosing production issues that led to the ingredient mix-up that ruined 15 million J&J shots. Federal regulators in March ordered AstraZeneca to leave Emergent’s plant, citing the production mishaps.
The agency also inspected Emergent’s facilities in February and October, but it is unclear whether the extent of these problems were laid out in previous reports.
FDA “takes its responsibility to ensure medical product quality, safety and effectiveness very seriously,” acting Commissioner Janet Woodcock and the agency’s vaccine chief Peter Marks said in a joint statement. “The American public puts its trust in 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 is working with Emergent to resolve the issues, will have to reinspect the plant and broadly test batches before clearing doses for release.
Woodcock and Marks said in their statement that all the already manufactured doses are undergoing additional testing but have not been clear for release yet. Doses made by Emergent are not authorized for emergency use, so none have been used by the public.