The Food and Drug Administration (FDA) on Wednesday issued a report on multiple failures at a troubled Baltimore vaccine manufacturing plant making Johnson & Johnson COVID-19 vaccine doses.
The report found the plant from Emergent BioSolutions, which previously was revealed to have ruined up to 15 million doses of vaccine, was “not maintained in a clean and sanitary condition” and some “procedures to prevent cross-contamination are not followed.”
The FDA has ordered a pause on manufacturing at the plant while the problems are addressed.
“For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution,” two top FDA officials, Peter Marks and Janet Woodcock, said in a statement. “We will not allow the release of any product until we feel confident that it meets our expectations for quality.”
The report said workers transported manufacturing waste through the warehouse in a way that could cause contamination, and cited peeling paint, among other factors.
The findings are the latest setback for Johnson & Johnson as it seeks to get its vaccine back on track. Separately, the vaccine’s use has been paused because of concerns around rare blood clots. That pause could be lifted as soon as Friday.
But there are also supply issues stemming from the problems at the Baltimore plant, and it is not clear when they will be addressed. When these issues are remedied, the supply of the vaccine would ramp up considerably.
The problems found at the factory do not affect doses of the J&J vaccine that were distributed before the pause over blood clots, as those doses were made in a different plant in the Netherlands.
“The quality and safety of our COVID-19 vaccine is paramount,” Johnson & Johnson said in a statement on Wednesday in response to the report, noting that it has stepped up oversight of the plant.
“Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively,” it continued.
Emergent BioSolutions added in a statement: “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.”
Updated 11:20 a.m.