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EU regulator finds possible blood clot link with J&J vaccine

EU regulator finds possible blood clot link with J&J vaccine
20.04.2021
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THE European Medicines Agency said Tuesday the Johnson & Johnson Covid-19 vaccine has possible links to rare blood clot incidents, but reiterated that its benefits still outweighed the risks.

″(The) EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen,” the agency said in a press release.

“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”

The EMA researched all available evidence, it said, including eight reports from the U.S. of serious cases of unusual blood clots — one of which had a fatal outcome. Over 7 million people had received the vaccine in the United States as of April 7, it said.

The U.S. Food and Drug Administration decided earlier this month to suspend the use of J&J’s shot “out of an abundance of caution.” As a result, the pharmaceutical firm decided to delay the rollout of its vaccine in Europe while regulators assessed any risks.

The EMA already said last week that while reviewing the latest details, it was still of the view that the benefits of the vaccine outweighed the risks.

“COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects,” the EMA stated on Tuesday, using the name of J&J’s Belgian unit.

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