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AMSTERDAM (Reuters) — Europe's drug regulator has found a possible link between Johnson & Johnson's COVID-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
The European Medicines Agency said on Tuesday its safety committee had concluded that a warning about unusual blood clots with low platelets must be added to the vaccine's labels, just as it has also required of rival vaccine maker AstraZeneca.
The findings are a blow to the European Union, which is battling major hurdles to its immunization campaign after several nations suspended or limited the use of AstraZeneca's vaccine over possible blood clots.
The EMA found that all instances of clotting had occurred in adults under 60 years, mostly women, within three weeks of vaccination with J&J's single shot.
It said all available evidence, including eight U.S. reports of cases, had formed part of its assessment.
The watchdog also said that most clots had occurred in the brain and abdomen, as was the case with AstraZeneca's shot, Vaxzevria, which is also being studied for similar blood clotting problems.
"One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin," the EMA said.
Sabine Straus, PRAC Chair: "The careful review of the cases and available evidence have led #PRAC to the conclusion that these blood clotting disorders are very rare side effects of the #COVID19vaccine Janssen."
— EU Medicines Agency (@EMA_News) April 20, 2021
Rare blood clots
The U.S. health regulator last week recommended pausing the use of the J&J single-dose shot after six women under the age of 50 developed rare blood clots after receiving it, in a fresh setback to global efforts to tackle the pandemic.
The cases were reported out of more than 7 million doses administered in the United States as of April 13, the EMA said.
J&J, which recorded $100 million in COVID-19 vaccine sales, has delayed rolling out the vaccine to Europe, but is prepared to resume the deployment. It has said it would aim to deliver 55 million doses to the EU, as contracted, by the end of June.
J&J's vaccine, developed by its Janssen unit, is one of four COVID-19 vaccines authorized for use in Europe.
(Reporting by Pushkala Aripaka in BengaluruEditing by Gareth Jones)
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