Europe resumes use of J&J COVID-19 vaccine after EMA review

By The Science Advisory Board staff writers

April 21, 2021 -- Rollout of the COVID-19 vaccine from Johnson & Johnson will resume after the European Medicines Agency (EMA) confirmed that the vaccine's overall benefit-risk profile remains positive.

The agency updated its use guidance after its Pharmacovigilance Risk Assessment Committee (PRAC) completed a review of a small number of cases of very rare adverse events involving blood clots in combination with low platelet counts. The events occurred within approximately one to three weeks of being vaccinated.

The company will resume shipment of the Janssen COVID-19 vaccine in the European Union, Norway, and Iceland.


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