Vaccine against Ebola: Commission grants first-ever market authorisation

Today, the European Commission adopted the decision granting marketing authorisation to the company Merck Sharp & Dohme B.V. for a vaccine against Ebola. This vaccine, called Ervebo, had been in development since the Ebola outbreak in West Africa in 2014. It is already used, as part of a specific protocol, to protect people at risk of infection, such as healthcare workers or people who have been exposed to infected persons.

This decision follows the recommendation from the European Medicines Agency (EMA), which has assessed the benefits and risks of the vaccine. It also follows the recent announcement of a clinical trial for a second Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) that is now under way in the Democratic Republic of Congo, with the support of the EU’s research and innovation programme Horizon 2020.

Vytenis Andriukaitis, Commissioner in charge of Health and Food Safety, said: “Finding a vaccine as soon as possible against this terrible virus has been a priority for the international community ever since Ebola hit West Africa five years ago. Today’s decision is therefore a major step forward in saving lives in Africa and beyond.”

Christos Stylianides, Commissioner for Humanitarian Aid and Crisis Management and EU Ebola Coordinator, said: “The EU is supporting international efforts to combat Ebola on all fronts, from vaccine development to delivering humanitarian aid on the ground. We will continue assisting the fight to tackle epidemic for as long as it takes.”

The clinical development of Ervebo was launched during the outbreak in West Africa five years ago. It was made possible through cooperation with public health stakeholders, which include national institutes of health, ministries of health in Africa (notably in Sierra Leone, Liberia, and Guinea), as well as the WHO, the Norwegian Institute of Public Health and Médecins Sans Frontières (MSF).

The development of the vaccine was supported by two projects from the Innovative Medicines Initiative (IMI) funded by the EU’s research and innovation programme Horizon 2020:

• VSV-EBOVAC (March 2015-Feb. 2019), led by Academisch Ziekenhuis Leiden (NL) with €3.9 million EU contribution,
• VSV-EBOPLUS (April 2016-March 2021), led by Merck Sharp & Dohme, with €8.5 million EU contribution.

Background

Ebola is a rare but severe illness caused by a virus of the same name. Death rates in patients who have contracted the disease have varied from 25% to 90% in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11 000 deaths. The current outbreak in the Democratic Republic of Congo (DRC), caused by Ebola Zaire, has shown case fatality rates of approximately 67%. More than 3 000 people have been infected with the Ebola virus during the ongoing outbreak, which was declared a public health emergency of international concern by the World Health Organization (WHO) in July 2019. WHO extended this decision for another three months in October 2019.

The authorisation of a medicine under the centralised procedure is a two-stage process, involving the European Medicines Agency (EMA) and the European Commission.

EMA assesses the benefits and risks of medicines and makes recommendations to the Commission, which then takes a final legally binding decision on whether or not the medicine can be marketed in the EU.

This decision is issued normally within 67 days (legal deadline) of the scientific opinion of EMA (for Ervebo the date was 17 October). This phase includes, among other things, the translation of the product guidelines in all EU languages and a consultation with Member States (Comitology). In view of the public health interest, the Commission has accelerated this process and authorised the medicine in less than a month, in other words cutting the decision-making process in half.

The assessment report for Ervebo will be published on EMA’s website.

Moreover, the EU is part of the Innovative Medicines Initiative (IMI), a public-private partnership, which has supported the clinical development of the investigational preventive Ebola vaccines, as well as diagnostic tests through the IMI Ebola+ call.