Johnson & Johnson has said that a batch of its Covid-19 vaccines 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.
The drugmaker said on Wednesday it had found a problem with an ingredient used in the Covid vaccine, which was being produced at a production site in Baltimore, Maryland, belonging to Emergent Biosolutions, one of about 10 companies that J& J is using to speed up manufacturing.
Workers at the plant manufacturing coronavirus shots for J&J and AstraZeneca accidentally conflated the vaccines’ ingredients several weeks ago, the New York Times earlier reported, adding that federal officials attributed the mistake to human error.
The issue was identified and addressed with Emergent and shared with the US Food and Drug Administration (FDA), J&J said, adding it was sending more people to supervise manufacturing at the plant.
J&J said the Emergent factory had not yet been approved by the FDA to make part of the vaccine. Emergent declined to comment.
J&J had pledged to provide 20m doses of its vaccine to the US government by the end of March, and 80m more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100m doses by the end of June and was “aiming to deliver those doses by the end of May”.
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 100m shots from J&J.
A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses.
As of Wednesday, J&J had provided about 6.8m doses, according to the US 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 an additional 11m doses of the vaccine would be available for shipments starting on Thursday.
It was not immediately clear where those 11m doses originated, but J&J has been shipping finished vaccines from its factory in the Netherlands to the US.
J&J said it was putting more of its manufacturing and quality experts inside Emergent’s Baltimore factory to supervise production of the vaccine, a move meant to enable delivery of an additional 24m vaccine doses through April.
The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.
J&J said it still expects to deliver more than 1bn vaccine doses globally by the end of the year.
The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.