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
Britain needs ‘AI stress tests’ for financial services, lawmakers say
- Lawmakers urge AI-specific stress tests for financial firms
LONDON: Britain’s financial watchdogs are not doing enough to stop artificial intelligence from harming consumers or destabilising markets, a cross-party group of lawmakers said on Tuesday, urging regulators to move away from what it called a “wait and see” approach.
In a report on AI in financial services, the Treasury Committee said the Financial Conduct Authority and the Bank of England should start running AI-specific stress tests to help firms prepare for market shocks triggered by automated systems.
The committee also called on the FCA to publish detailed guidance by the end of 2026 on how consumer protection rules apply to AI, and on the extent to which senior managers should be expected to understand the systems they oversee.
“Based on the evidence I’ve seen, I do not feel confident that our financial system is prepared if there was a major AI-related incident and that is worrying,” committee chair Meg Hillier said in a statement.
TECHNOLOGY CARRIES ‘SIGNIFICANT RISKS’
A race among banks to adopt agentic AI, which unlike generative AI can make decisions and take autonomous action, runs new risks for retail customers, the FCA told Reuters late last year.
About three-quarters of UK financial firms now use AI. Companies are deploying the technology across core functions, from processing insurance claims to performing credit assessments.
While the report acknowledged the benefits of AI, it warned the technology also carried “significant risks” including opaque credit decisions, the potential exclusion of vulnerable consumers through algorithmic tailoring, fraud, and the spread of unregulated financial advice through AI chatbots.
Experts contributing to the report also highlighted threats to financial stability, pointing to the reliance on a small group of US tech giants for AI and cloud services. Some also noted that AI-driven trading systems may amplify herding behavior in markets, risking a financial crisis in a worst-case scenario.
An FCA spokesperson said the regulator welcomed the focus on AI and would review the report. The regulator has previously indicated it does not favor AI-specific rules due to the pace of technological change.
The BoE did not respond to a request for comment.
Hillier told Reuters that increasingly sophisticated forms of generative AI were influencing financial decisions. “If something has gone wrong in the system, that could have a very big impact on the consumer,” she said.
Separately, Britain’s finance ministry appointed Starling Bank CIO Harriet Rees and Lloyds Banking Group ‘s Rohit Dhawan as “AI Champions” to help steer AI adoption in financial services.
