J&J vaccine’s producer has past violations

The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.

Emergent Biosolutions, a little-known company vital to the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May.

But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.

Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory cannot be used because it did not meet quality standards.

“Human errors do happen,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said Thursday on CBS’ “This Morning.” “You have checks and balances. … That’s the reason why the good news is that it did get picked up. As I mentioned, that’s the reason nothing from that plant has gone into anyone that we’ve administered to.”

White House press secretary Jen Psaki said Thursday that none of the J&J vaccine doses on the market are affected and the company was on track to deliver 24 million doses in April and 100 million doses by the end of May.

“These are doses that the U.S. government has purchased, but we also have plenty of doses from Pfizer and Moderna, regardless,” Psaki said.

J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year.