Vaccine against Ebola: Commission grants first-ever market authorisation

ebola news.jpg

Finnish Red Cross/Maria Santto Rinsing Ebola protective gear in Beni, Democratic Republic of the Congo.

This article is brought to you in association with the European Commission.


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.

the sting Milestones

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

EU Emissions Trading System does not hurt firms’ profitability

UN chief calls for ‘solidarity, compassion and action’ on World Refugee Day

Here’s how to check in on your AI system, as COVID-19 plays havoc

Amid ‘unprecedented combination’ of epidemics, UN and partners begin cholera vaccination campaign in DR Congo

To Brexit, or not to Brexit…rather not: 10 Downing Street, London

How debt for climate swaps could spur a green recovery

5 steps to safe and effective COVID-19 vaccine distribution

Rise in Caribbean children displaced by storms shows climate crisis is a child rights issue: UNICEF

New rules for audiovisual media services approved by Parliament

Making the most of our ‘extra time’ – for ourselves and society

MEPs call on Russia to stop illegitimate prosecution of Lithuanian judges

UN General Assembly celebrates 20 years of promoting a culture of peace

Four million have now fled Venezuela, UN ramps up aid to children who remain

UN highlights importance of skills development on World Youth Skills Day

China and the EU agree to protect each other’s food and drink specialities

One-sixth of the world’s economy has now pledged to cut CO2 to zero by 2050

What is an immunity passport and could it work?

The benefits of a cashless society

Innovative urban financing can make our cities stronger

70 years after the Universal Declaration of Human Rights, this is why we need dignity more than ever

UN-backed intercultural dialogue forum urged to keep working to ‘bridge gap between the like-minded’

How to prevent a suicide?

Parliament adopts deal to improve quality of tap water and reduce plastic litter

What we can learn from Asia’s courts of the future

Somalia advancing towards ‘inclusive and peaceful future’ for women, deputy UN chief

Sexual and Reproductive Health and Rights and ending HIV, one single goal

The third bailout agreement for Greece is a done deal amid European economies full of problems

How our global battle against coronavirus could help us fight climate change

FROM THE FIELD: Powering up health care in Sub-Saharan Africa

Outbreak of COVID-19: The third wave and the people

How can we ensure energy is clean, secure and affordable?

Do the giant banks ‘tell’ Britain to choose a good soft Brexit and ‘remain’ or else…?

Your smartphone may know more about your mental health than you

Innovations in reusable packaging need a playbook. Here’s why

Why cybersecurity should be standard due diligence for investors

State aid: Commission approves Danish support for Thor offshore wind farm project

Investment Plan for Europe: European Investment Bank to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing

Commission takes further action to ensure professionals can fully benefit from the Single Market

Theresa May in search of a magic plan to invoke Article 50 and start Brexit negotiations now

Austerity ends in Eurozone, Germany is isolated

Do not take the EP’s consent on MFF for granted, says Budget Committee Chair

Sherpa climbers carried out the highest-ever spring clean. This is what they found

New UN data tool shows ‘mismatch’ between government aid and places modern slavery exists

Chart of the day: This is why we need to protect nature’s pollinators

The eyes of Brazil and the world turn to the largest rainforest and largest biodiversity reserve on Earth #PrayForAmazonia.

We need to change the fast fashion model. Here’s how

Coronavirus response: Commission welcomes agreement on crucial VAT relief for vaccines and testing kits

Lithuania finds the ways to maintain its energy security

Africa must use tech to chase corruption out of the shadows

Do the EU policies on agro-food smell?

More than 30 years of US trade with China, in one chart

Myanmar companies bankroll ‘brutal operations’ of military, independent UN experts claim in new report

Deadly violence at Israel-Gaza border escalates dangerously: UN chief condemns in strongest terms

What has a year of experiments taught us about basic income?

UNICEF warns of ‘lost generation’ of Rohingya youth, one year after Myanmar exodus

Eurozone needs more than some decimals of growth

UN Chief says ending poverty ‘a question of justice’ on International Day

FROM THE FIELD: Urban Mexico moves toward better livelihoods, cleaner cities

The Sting’s Values

Impacting society with digital ingenuity – World Summit Award proclaiming the top 8 worldwide

More Stings?

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s