A batch of Johnson & Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant said late Wednesday.
The drugmaker 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 Johnson & Johnson 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 US Food and Drug Administration to make part of the vaccine.
Emergent, which has been producing bulk drug substance at one of its factories in Baltimore, declined to comment.
J&J had pledged to provide 20 million doses of its vaccine to the US 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 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 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 J&J spokesman said earlier Wednesday that J&J 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, J&J had provided about 6.8 million 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 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 US
The FDA said it was aware of the situation but referred questions to Johnson & Johnson.
The problem with the vaccine batch was first reported by The New York Times.
Johnson & Johnson COVID-19 vaccine batch fails quality check
https://arab.news/wb4ne
Johnson & Johnson COVID-19 vaccine batch fails quality check
- J&J had pledged to provide 20 million doses of its vaccine to the US government by the end of March
Debris removal steps up at Karachi fire-hit plaza as death toll nears 60
- KMC teams remove debris under safety precautions as search for the missing continues
- Authorities are keeping agencies on alert amid rain forecast as the site remains unstable
ISLAMABAD: Municipal and rescue teams stepped up debris removal operations at a fire-hit shopping plaza in Pakistan’s largest city of Karachi on Wednesday, as officials said the death toll from the blaze has climbed to nearly 60 and the search for missing victims continues.
Teams from the Karachi Metropolitan Corporation (KMC) are clearing rubble from Gul Plaza, a multi-story shopping complex where a fire broke out late Saturday, under strict safety measures, with debris being transported to a designated ground in the city’s Meva Shah area, an official statement said.
“Rescue teams are continuously engaged in search and clearance operations to locate any remaining victims,” the statement circulated by the KMC said, adding that authorities were aiming to complete the process as soon as possible while ensuring safety.
Located in Karachi’s densely populated Saddar district, the fire at Gul Plaza burned for more than 24 hours before being brought under control. The blaze gutted more than 1,200 shops, triggered partial structural collapse and left dozens of people trapped inside.
With rain forecast in the coming days, authorities have placed all relevant departments on alert and are making contingency preparations to prevent further risks at the site, the KMC statement said.
The disaster at the shopping mall has renewed scrutiny of fire safety standards in Karachi’s commercial buildings, where overcrowding, illegal construction and weak enforcement have repeatedly contributed to deadly incidents.
Following the Gul Plaza fire, the Sindh Building Control Authority has warned developers and building owners to address fire safety violations or face legal action.
Deadly fires remain a recurring threat in the city of more than 20 million people, despite periodic crackdowns ordered after major disasters.
