Johnson & Johnson vaccine batch fails quility check
A batch of Johnson & Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant said.
They 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 J&J is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said.
J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine. Emergent declined to comment.
J&J had pledged to provide 20 million doses of its vaccine to the U.S. 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 U.S. adults by the end of May. The U.S. 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.
A J&J spokesman said that the company met the March goal, but did not respond to questions about whether the Emergent plant in Baltimore had been cleared by FDA.
J&J hasprovided about 6.8 million doses to the U.S. vaccine effort, according to the Centers for Disease Controland Prevention’s online vaccine tracker. Health officials said that another 11 million doses would be available for shipments starting on Thursday.
Emergent was granted a major role in the federal government’s response to coronavirus pandemic. J&J said it was putting more of its experts inside Emergent’s factory to supervise production, a move meant to enable delivery of an additional 24 million vaccine doses through April.
J&J said it still expects to deliver over 1 billion vaccine doses globally by the end of the year. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.