J&J vaccine fails quality test
NEW MEXICO: A batch of Johnson & Johnson’s Covid-19 vaccine failed quality standards and can’t be used, the drug giant said on Wednesday (Thursday in Manila). The drugmaker didn’t say how many doses were lost, and it wasn’t clear how the problem would impact future deliveries.
A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said.
About 15 million doses of the single-shot coronavirus vaccine made by J&J were ruined in a factory error in the United States, The New York Times reported — a blow to the company’s efforts to quickly boost production.
When contacted by Agence France-Presse, the pharmaceutical giant said it had identified a batch of doses at a plant in Baltimore run by Emergent BioSolutions “that did not meet quality standards” but did not confirm the specific number affected.
J&J said the Emergent BioSolutions factory involved had not yet been approved by the US Food and Drug Administration (FDA) to make part of the vaccine. Emergent declined to comment.
J&J had pledged to provide 20 million doses of its vaccine to the US government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said 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.”
President Joe Biden has pledged to have enough vaccines for all US adults by the end of May. The US government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J.
As of Wednesday, J&J had provided about 6.8 million doses to the US vaccine effort, according to the Centers for Disease Control and Prevention’s online vaccine tracker.
Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday.
It was not immediately clear where those 11 million doses originated, but J&J has been shipping finished vaccines from its factory in the Netherlands to the US.
Emergent, a little known pharmaceutical company granted a major role in the federal government’s response to coronavirus pandemic, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.