J&J vaccine should be administered with warning label, EU regulator says

Katie Adams - Print  | 

The European Medicines Agency, the European Union's equivalent to the FDA, said April 20 that the bloc should not ban Johnson and Johnson's COVID-19 vaccine, but a label should be added to warn about the rare possibility of blood clots.

Johnson & Johnson delayed its vaccine rollout in the E.U. after the FDA and CDC paused use of the shot in the U.S. April 13 to review six reports of a rare but serious blood clotting side effect. 

The EMA said the risk of blood clots outweighs the vaccine's benefits. The agency also said the cases of blood clots linked to Johnson & Johnson's shot are "very similar" to the blood clots associated with AstraZeneca's vaccine, for which it made a similar recommendation.

The agency said E.U. member states can independently decide whether to continue using Johnson & Johnson's shot, taking into account their COVID-19 case load and vaccine availability. The EMA also issued guidelines to help healthcare providers diagnose, treat and record any blood clots that could result from a COVID-19 vaccination.

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