United Kingdom

EU regulator finds 'possible link' between Johnson & Johnson Covid vaccine and blood clots

The EU’s drug regulator has said there is a possible link between Johnson & Johnson's Covid-19 vaccine and rare blood clots.

The European Medicines Agency (EMA) said a warning about unusual blood clots with low blood platelets should be added to the vaccine's labels as a very rare side effect of the single shot jab.

The EMA said that the benefits of the J&J vaccine far outweighed the risks and that further investigations would continue. 

Executive Director Emer Cooke said: "This is a very rare effect but it also makes it very important for doctors and patients to be aware of the signs... early intervention by a specialist can change the outcome."

"I have to stress again that they are very rare and that in the vast majority of cases these vaccines are going to prevent death and hospitalisation from Covid-19," she added.

The signs of blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain and blurred vision. The EMA said that most clots had occurred in the brain and abdomen, similar to AstraZeneca's vaccine, which also now carries a side effect warning after it was linked to rare blood clots. 

The EMA said all instances had occurred in adults under the age of 60, mostly women, and within three weeks of vaccination. It said that all available evidence, including eight reports of cases in the United States after seven million vaccinations, were part of its assessment. 

There have not been any European cases so far, but the number of vaccinations given in the EU are far lower. The EMA said the cause of the clots was unknown but could be an immune response.

J&J halted the roll out of the vaccine last week after the reports of the blood clots. Many EU member states were waiting for the results of the EMA probe before administering the jab, which was authorised in the EU on March 11, 2021. 

But some countries, such as France, have pressed ahead with the J&J jab, although the French have only used it in adults over the age of 55.  

There are fears that the delays or restrictions put on the use of the J&J vaccine could slow the EU’s vaccination rollout, which has finally begun to pick up speed after months of lagging behind countries such as the UK, US and Israel.

Some EU countries introduced age limits on the AstraZeneca vaccine after it was linked to rare blood clots, despite the EMA saying it was suitable for all adults. Denmark has entirely stopped using the AstraZeneca jab over the link. 

EMA experts said it was too early to say whether the J&J jab was less or more dangerous than the AstraZeneca vaccine, but that the cases were "very similar" to the blood clots linked to the Oxford vaccine. 

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