The European Commission authorised the Ebola vaccine Ervebo for Europe on 11 November 2019. The authorisation was supported through the PRIority MEdicines (PRIME) scheme at the European Medicines Agency (EMA), which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. Quality, safety and efficacy are nevertheless checked with the same carefulness as in a usual authorisation process.
"We are pleased to announce the availability of an authorised vaccine against Ebola. The accelerated authorisation under the PRIME scheme confirms this procedure as a way to deliver needed and previously unavailable medicines as quickly as possible without compromising safety,"
said Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines.
The large-scale Ebola epidemic in West Africa in 2014 triggered joint international efforts to rapidly develop a vaccine against Ebola. There is currently another large Ebola outbreak in the Democratic Republic of Congo. The vaccine has already been used locally as part of a compassionate use programme.
The EMA´s Committee for Medicinal Products for Human Use (CHMP) issued the recommendation for authorisation on 17 October 2019, which has now been followed by the European Commission. The review of the CHMP recommendation and the decision by the European Commission were made in an accelerated procedure in the interest of public health.
The approval was granted conditional marketing authorisation, as further information on the manufacturing process will only be available in the upcoming months. The vaccine Ervebo (rVSVΔ-ZEBOV-GP) from Merck Sharp & Dohme B.V. is a genetically engineered live attenuated vector vaccine.
The PEI is represented in the CHMP by an expert and authorised a clinical trial for the vaccine in Germany.
Updated: 13.11.2019
