Firm at heart of J&J vaccine woes has history of safety citations

Emergent BioSolutions has been cited for issues such as poorly trained employees, cracked vials and mould, the AP reported.

The company at the centre of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from United States health officials for quality control problems. Emergent BioSolutions, a little-known company at the centre of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the US by the end of May. But the company has been cited repeatedly by the Food and Drug Administration (FDA) for problems such as poorly trained employees, cracked vials and mould 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, known as Bayview, can’t be used because it didn’t meet quality standards. It was unclear how many doses were involved or how the problem would affect future deliveries of J&J’s vaccine. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”