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EU regulator says benefits of J&J vaccine outweigh risk of rare blood clots

The European Medicines Agency (EMA) said Tuesday that unusual blood clots should be listed as a "very rare" side effects of Johnson & Johnson's coronavirus vaccine, but that the benefits of the shot still outweigh the risks.

Why it matters: The agency's determination of a "possible link" to a rare kind of blood clot comes ahead of an expected ruling by the U.S. FDA this week on whether to lift its pause on the J&J vaccine rollout.


Details: Since the J&J vaccine has not yet been distributed in Europe, the data that the EMA reviewed came from the eight reports of rare blood clots reported in the U.S. out of 7 million vaccine total doses administered.

  • "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 said in a statement.
  • The agency recently made a similar recommendation about the AstraZeneca vaccine, determining that the benefits of its protection against COVID-19 outweigh the risks of rare blood clots.

Between the lines: Most Americans support the pause in distribution of the Johnson & Johnson COVID-19 vaccine, and so far there's no evidence that it's leading to broader vaccine hesitancy, according to the latest installment of the Axios/Ipsos Coronavirus Index.

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