J&J Covid vaccine rollout to recommence in Europe

April 21, 2021

European Medicines Agency confirms that the benefits exceed the risks

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of Johnson & Johnson's Covid-19 vaccine, confirming that the overall benefit-risk profile remains positive; J&J will be resuming its shipment to the EU, Norway and Iceland immediately. The PRAC investigated cases of events involving blood clots in combination with low platelet counts that can take place within about one to three weeks following injection with the one-dose shot.

Subsequently, J&J be revising its Covid-19 vaccine “Summary of Product Characteristics” and label to feature content on the diagnosis and management of what the company refers to as a “rare adverse event.” Healthcare professionals will be notified of the signs and symptoms of thromboembolism with thrombocytopenia, along with how to properly combat it.

Meanwhile, in the US, vaccine advisers from the CDC will be meeting Friday to discuss the vaccine's status. Officials, however, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, reportedly expect the rollout to resume in the US, though it may come with restrictions.