EU batches of J&J Covid-19 vaccine withheld as ‘precaution’ after contamination at US factory – EMA

The European Medicines Agency (EMA) has said it is aware of a contaminated batch of the active substance used to make Johnson & Johnson’s Covid-19 vaccine and that they’re taking precautionary action to prevent possible harm.

In a press release on Friday, the EMA said contamination had occurred at a manufacturing site for the active substance in Maryland, US. While the contaminated batch was not intended for the EU market, other batches of the active substance made in the same facilities were intended for the 27-nation bloc. 

The EU drugs regulator said precautionary measures are being taken “to safeguard the quality of vaccines” and that the relevant authorities have “recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred.”

The EMA statement adds that the authorities will do everything possible to ensure the precautionary measures do not delay the delivery of vaccines.

In March, it emerged that Emergent BioSolutions’s manufacturing plant in Maryland had mistakenly used the wrong ingredients in millions of Johnson & Johnson shots, although none of the 15 million jabs left the factory. The New York Times reported that US officials suggested the incident was a result of human error.  

In April, the US Food and Drug Administration deemed, after an investigation, that the plant was dirty and had procedural problems. It later emerged that as many as 100 million doses would need to be checked for contamination and Emergent BioSolutions CEO Robert Kramer announced that the company would suspend its 24/7 operations. 

The Johnson & Johnson vaccine, which is delivered via a single dose, is one of four shots currently approved for use in the European Union. Its rollout was initially temporarily delayed in the bloc amid concerns of very rare cases of blood clots and low blood platelets after incidents were reported in the US. 

On Thursday, European Commission President Ursula von der Leyen announced that 50% of EU adults have now had at least one vaccine shot against Covid-19.

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