Johnson & Johnson COVID-19 Vaccine roll-out to resume in Europe following European Medicines Agency review.

Johnson & Johnson announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a result, Johnson & Johnson will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropriate course of treatment. Following the PRAC recommendation, the Company will resume shipment of the Janssen COVID-19 vaccine in the European Union (EU), Norway and Iceland. The updated EMA and Healthcare Professionals guidance will be available to national healthcare authorities. The U.S. Centers for Disease Control and Prevention (CDC) and the FDA currently are reviewing these same cases. On April 14, 2021, the CDC convened a meeting of the Advisory Committee on Immunization Practices (ACIP) to review these cases and assess their potential significance. The ACIP plans to reconvene on April 23, 2021, for further discussion..