Following an ingredient mixup by the workers at Emergent BioSolutions' plant, the New York Times newspaper has reported that about 15 million doses of Johnson & Johnson's COVID-19 vaccine have been ruined and thereby delaying future shipments.
Federal officials attributed the mistake to "human error".
The Times reporter that the error would not affect doses that are already being delivered across the US but would cause delays for tens of millions of doses of the vaccine that were meant to come from the Baltimore plant in the coming months. It did not say how long those delays could be.
"The quality control process identified one batch of drug substance that did not meet quality standards" at the Emergent BioSolutions facility, but did not say how many doses of its single-dose vaccine were ruined," the company said in its statement.
"This batch was never advanced to the filling and finishing stages of our manufacturing process," Johnson & Johnson said, adding that the issue was addressed with Emergent BioSolutions and the US Food & Drug Administration (FDA).
Vials with a sticker reading, 'COVID-19 / Coronavirus vaccine / Injection only' and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020 [File: Dado Ruvic/Illustration/Reuters]
The company also said it would deploy additional experts to the plant to supervise manufacturing as it moves towards an emergency-use authorisation for the facility.
"In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April," it said.
The Johnson & Johnson vaccine has been credited with helping to speed up the US vaccine drive, which has ramped up since President Joe Biden came into office in January.
The US has administered more than 150.2 million vaccines and more than 54 million people were fully vaccinated as of Wednesday, according to Centers for Disease Control and Prevention (CDC) data. Nearly 200 million doses have been delivered nationwide.
Federal officials still expect to meet Biden's goal of having enough vaccines to jab every US adult by May despite the Johnson & Johnson delay, the New York Times reported.
The US – which has recorded more than 30 million COVID-19 cases and more than 551,000 coronavirus-related deaths to date, according to a Johns Hopkins University tally – is seeing a new wave of coronavirus infections.
CDC Director Dr Rochelle Walensky, who earlier this week said she felt "impending doom" amid the rising case numbers, said on Wednesday that COVID-19 had pushed deaths in the US beyond 3.3 million last year – 16 per cent higher than in 2019.
"The data should serve again as a catalyst for each of us to continue to do our part to drive down cases and reduce the spread of COVID-19 and get people vaccinated as quickly as possible," she said during a news briefing.
The coronavirus hit communities of colour particularly hard, Walensky said, with the life expectancy for non-Hispanic Black people dropping by 2.7 years. It also decreased by 1.9 years for Hispanic people.
"Sadly, based on the current state of the pandemic, these impacts have remained in 2021 where we continue to see that communities of colour account for an outsize portions of these deaths," she said.