Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)
Last Situation Report published 23 June 2020
Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine
:: This marks the first major regulatory approval of a vaccine developed by Janssen
:: The Ebola vaccine regimen leverages Janssen’s AdVac® technology, plus Bavarian Nordic’s established MVA-BN® technology
: Janssen’s AdVac® technology is also being used to develop a vaccine candidate to prevent COVID-19
July 01, 2020 09:22 AM Eastern Daylight Time
NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health Organization (WHO) on vaccine pre-qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need.
Two Marketing Authorisation Applications (MAAs) were submitted to the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Marketing Authorisation under exceptional circumstances has been granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Janssen’s Ebola vaccine regimen is indicated for active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above.
“The European approval of Janssen’s Ebola vaccine regimen is a landmark moment – both for our Company and in the world’s battle against the deadly Ebola virus. Building on our history, we are committed to bringing forward vaccines to help overcome the threat of some of the world’s most life-threatening infectious diseases,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson…