Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa
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Up to 200,000 Johnson & Johnson
Ebola vaccine regimens will be made available as part of a WHO early access clinical program now underway in Sierra Leone
Company s Ebola vaccine regimen also receives Prequalification from the WHO
The Johnson & Johnson vaccine regimen is designed to be used proactively to induce immunity against Ebola in adults and children
NEW BRUNSWICK, N.J., May 13, 2021 /PRNewswire/ Johnson & Johnson (NYSE: JNJ) (the Company) today announced the World Health Organization (WHO) and the government of Sierra Leone have begun administering the Company s Ebola vaccine regimen as part of a WHO early access clinical program aimed at preventing further spread of Ebola in West Africa. The vaccine regimen, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) in collaboration with Bavarian Nordic A/S,
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Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency
The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.
The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.
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NEW BRUNSWICK, N.J., April 23, 2021 /PRNewswire/ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).
The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.
Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U S for All Adults Aged 18 and Older Following CDC and FDA Decision investingnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investingnews.com Daily Mail and Mail on Sunday newspapers.
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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.