‘Human Error’ Ruins 15 Million Johnson & Johnson Vaccines, Report Says
A batch of Johnson & Johnson's COVID-19 vaccine failed quality standards and can't be used, the drug giant said late Wednesday.
The New York Times reported that "human error" involving workers at a Baltimore plant had ruined about 15 million doses of Johnson & Johnson’s vaccine, distributed under the Janssen brand.
Emergent BioSolutions runs the facility and is a manufacturing partner to both Johnson & Johnson and AstraZeneca, according to the same New York Times report, which was the first to report on the vaccine batch setback.
The drug maker did not confirm as of Wednesday evening how many doses were lost and also did not comment further on how the problem would impact future deliveries.
Emergent BioSolutions is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine.
J&J said the factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine.
The AstraZeneca COVID-19 vaccine has not yet been approved in the U.S., as the Food and Drug Administration has asked for more data and results from a large-scale trial, as reported by Vox.
Ahead of any anticipated approval, Emergent entered a partnership last summer, to being ramping up production of the drug ingredients ahead of commercial supply.
Emergent declined to comment on the Johnson and Johnson vaccine batch issue.
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 federal official said Wednesday evening the administration's goal can be met without additional J&J doses.
A Johnson & Johnson spokesman said earlier Wednesday that the company met the end-of-March goal but did not respond to questions about whether the Emergent plant had been cleared by FDA.
As of Wednesday, Johnson & Johnson had provided about 6.8 million doses, according to the U.S. Centers for Disease Control and Prevention's online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and the CDC 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 Johnson & Johnson has been shipping finished vaccines from its factory in the Netherlands to the U.S.
The FDA said it was aware of the situation but referred questions to Johnson &a Johnson.
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