Kanyle. Foto: Colourbox.dk

DTU’s part in assessing the safety of the world’s first Ebola vaccine

Wednesday 11 Dec 19

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Agnieszka Podolska-Charlery
Senior Scientific Officer
National Food Institute
+45 91 37 00 67

The world got its first commercial vaccine against Ebola in November 2019. The National Food Institute, Technical University of Denmark (DTU), has played a part in assessing that it is safe to use.

Vaccines have been used for more than 200 years to prevent a number of serious, contagious diseases. In the past five years, experts have been working hard to find a vaccine against Ebola—an extremely contagious disease, which kills up to 90% of those who contract it, according to Doctors Without Borders.

In November 2019, the work to find an Ebola vaccine led to the first commercial vaccine against the disease being put on the market in Europe. The vaccine was only able to be put on the market after an assessment from the European Medicines Agency, EMA, showed that it is safe to use.

EMA has drawn on GMO experts from DTU 

Before the EMA can approve the use of a vaccine, it must undergo a comprehensive safety and risk assessment. During this process, European experts appointed in cooperation with the Competent Authorities in the Member States, have thoroughly examined all components of the vaccine.

In Denmark, the Danish Agricultural Agency has approved the National Food Institute—by virtue of its knowledge of genetically modified organisms, GMOs—to participate in the work of conducting risk assessment of vaccines that contain or consist of a GMO. The new Ebola vaccine, Ervebo, is one such vaccine.

As such, one of the Institute’s experts has assessed the health risk for people, who come into contact with the vaccinated person or handle the vaccine, as well as the risk associated with the GMO itself by assessing its ability to change and spread. 

During this process, the Institute has asked the applicant for more clarification and information, which was needed to conduct the risk assessment. Based on the additional information and other available knowledge, the National Food Institute has assessed that the GMO in the vaccine poses a negligible risk.

Based on the many contributions to the safety and risk assessment, the EMA concluded that Ervebo is safe to use, and on 11 November 2019, the European Commission gave permission for the vaccine to be sold on the European market. 

More than 100,000 have already been vaccinated

For more than a year, the Democratic Republic of the Congo has been fighting the second most deadly Ebola outbreak in history of the world.

Although the Ervebo vaccine only recently received the official green light, more than 100,000 people in the affected areas and a large number of aid workers have already been vaccinated against Ebola. This has been possible because permission has been given for so-called compassionate use of the vaccine.

Compassionate use is an opening in the rules that allows medicines to be given for deadly diseases for which there is no other treatment option, before it is given final approval. 

Read more

The National Food Institute provides scientific advice based on new and existing research to both national and international authorities. Read more about these tasks on the National Food Institute’s website: Scientific advice.

During 2019, the National Food Institute has provided the Danish Agricultural Agency with risk assessments of the GMO contained within nine different pharmaceuticals and vaccines.

Find more information about EMA’s role in preventing Ebola outbreaks in one of the organization’s own publications: EBOLA – Fighting the outbreaks.

 

Vaccination strategy against Ebola

In the event of an Ebola outbreak, a vaccine can be given as a so-called "ring vaccine" to people who have had varying degrees of contact with persons suspected of having been infected with the virus. It will prevent the disease from spreading further, as people who have received the vaccine will be resistant to the virus if exposed to it.

Furthermore, frontline staff such as health care workers, ambulance drivers and cleaning staff at the hospitals routinely get the vaccine. The aim is to contribute to stopping outbreaks.

In connection with the worst Ebola outbreak on record, which occurred in West Africa from 2014-2016, more than 11,300 people died according to Doctors Without Borders.

Find more information about how Ebola is transmitted and the work to stop outbreaks on Médecins Sans Frontières/Doctors Without Borders' website: Ebola and Marburg.

https://www.food.dtu.dk/english/news/Nyhed?id=%7B960CB0DD-0366-4BCC-8874-E9264B46F042%7D
29 FEBRUARY 2020