First Ebola Vaccine Gains Conditional Marketing Authorization Recommendation

According to an Oct. 18, 2019 press release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the European Union (EU).

Clinical development of an Ebola vaccine was started in response to the outbreak of the disease in 2014–2016 and has involved the cooperation of various public stakeholders, such as national institutes of health, ministries of health in countries including Guinea and Democratic Republic of Congo (DRC), World Health Organization, the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, Médecins Sans Frontières, and others. Ervebo, a genetically engineered, replication-competent, attenuated live vaccine, has been tested in approximately 16,000 individuals across multiple clinical studies in Africa, Europe, and the United States. In these studies, the vaccine has been proven to be safe, immunogenic, and effective against the Zaire Ebola virus, which is the cause of the current outbreak in DRC.

“This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s executive director, in an Oct. 18, 2019 press release. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.”

“EMA’s positive opinion for the first vaccine against Ebola virus disease demonstrates the scientific expertise in the EU that can be mobilized to reduce the impact of deadly diseases like Ebola,” added Harald Enzmann, chair of the CHMP.

Source: EMA