Stay updated with breaking news from Janssen summary. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Hits: 143 EMA Confirms Overall Benefit-Risk Profile Remains Positive Company to update the COVID-19 Vaccine Janssen Summary of Product Characteristics and Package Leaflet to include important information on very rare adverse event Johnson & Johnson remains committed to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland NEW BRUNSWICK, NJ, USA I April 20, 2021 I Johnson & Johnson (NYSE: JNJ) (the Company) today 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. ....