BALTIMORE (WJW/AP) — Nearly 15 million doses of the Johnson & Johnson COVID-19 vaccine were thrown away after a dosage mix-up at the Baltimore production plant, multiple news outlets have reported.
Johnson & Johnson confirmed late Wednesday that a batch of the COVID-19 vaccine failed quality standards and can’t be used. The drugmaker didn’t say how many doses were lost, and it wasn’t clear how the problem would impact future deliveries.
Johnson & Jonhson said a vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that the drugmaker is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, putting shipments on hold.
According to the New York Times, nearly 15 million doses of the Johnson & Johnson vaccine were ruined. Federal regulators reportedly attributed the mistake to “human error” and have delayed authorization of the plant’s production lines.
However, this mix-up reportedly did not affect doses of the Johnson & Johnson vaccine that are currently being delivered and used nationwide. The New York Times says those doses were produced in the Netherlands and operations were fully approved by U.S. Food and Drug Administration officials.
Johnson & Jonhson said the Emergent BioSolutions factory involved had not yet been approved by the FDA to make part of the vaccine.
Emergent, which has been producing bulk drug substance at one of its factories in Baltimore, declined to comment.
Johnson & Jonhson 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 Johnson & Johnson. A federal official said Wednesday evening the administration’s goal can be met without additional Johnson & Johnson doses.
The FDA said it was aware of the situation but referred questions to Johnson & Johnson.