On 18 October 2019, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicine Agency (EMA) recommended the granting of the marketing authorisation for the Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP) in the EU. This is the first vaccine designed to confer protection against an infection with Ebola virus. The European Commission is likely to agree to the favourable opinion from the CHMP, and will thus grant the marketing authorisation for the EU.
"At the time of the Ebola virus outbreak of 2014, the Paul-Ehrlich-Institut spoke strongly in favour of the clinical trial for the vaccine, since reliable data, which allow an assessment of the efficacy and safety of the vaccine can only be obtained in controlled clinical trials,"
said Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut (PEI). Clinical trials constitute an indispensable basis for the marketing authorisation of vaccines. A phase-1 clinical trial was performed in Germany at the time. "I am happy to say that the PEI, with its various initiatives, has been able to advance clinical testing and development of the Ebola vaccine and was thus able to contribute to establishing the manufacture at the site of Germany"
, Professor Cichutek continued.
The most serious Ebola outbreak in the more recent years occurred in West Africa from 2014 to 2016 with more than 11,000 casualties. For the present outbreak in the Democratic Republic of the Congo (DRC), the death rate is around 67 percent. In July 2019, the World Health Organization (WHO) declared the current outbreak to be an emergency of international significance.
The Ervebo vaccine is a genetically engineered attenuated live vector vaccine. Data from clinical trials and the use within the compassionate use/expanded access programme have shown that a single dose of the Ervebo vaccine confers protection from the Ebola virus infection. The recommendation by the CHMP is the result of extensive world-wide collaboration. The marketing authorisation process of the Erebo vaccine for Europe was performed in the accelerated PRIME procedure.
In the current Ebola outbreak in the Democratic Republic of the Congo, the vaccine is already being used within the Compassionate Use Programme to protect persons with the highest infection risk, such as members of the health service or individuals who have come into contact with infected patients or their contact persons. The vaccination of the contact persons was performed as part of a ring vaccination strategy which, already in West Africa, is intended to reduce the spreading of the disease.
Updated: 18.10.2019
