New Brunswick-based 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 dompany’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 safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally. We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use.”
Data from the global ENSEMBLE Phase 3 trial demonstrated the company’s single-dose vaccine provided protection against COVID-19 related hospitalization and death across demographics and geographies, including areas with emerging variants.
The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) currently are reviewing these same cases. On April 14, 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 for further discussion.
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