FDA finds multiple failures at J&J plant

The 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.”

Previous J&J doses: 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.

Could spell trouble for J&J: The plant’s shortcomings could be a major hindrance for J&J to meet its goal of 100 million doses delivered to the U.S. by the end of May.

Federal officials had been counting on the Emergent plant to play a major role in ramping up manufacturing, but it could take months to fix all the problems cited by FDA. In the meantime, J&J in a statement said it is “establishing a global vaccine supply network” in order to meet its commitments. Ten manufacturing sites will be involved in the production of the vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed globally.