Zabdeno
Authorised
This medicine is authorised for use in the European Union
ebola vaccine (Ad26.ZEBOV-GP [recombinant])
MedicineHumanAuthorised
Overview
Zabdeno is a vaccine to protect adults and children aged one year and older against Ebola virus disease caused by Zaire ebolavirus. It is used with another Ebola vaccine called Mvabea as part of a vaccine regimen.
Zabdeno contains a virus known as adenovirus which has been modified to allow the production of a protein from Zaire ebolavirus. The adenovirus itself has no effect on humans. Zabdeno only contains a small part of Zaire ebolavirus and cannot cause Ebola virus disease.
Zabdeno can only be obtained with a prescription and is given by a trained healthcare worker. It is given as a single injection, followed by an injection of Mvabea about 8 weeks later. People who are at imminent risk of infection with Ebola virus and have received the Zabdeno and Mvabea injections more than 4 months earlier can receive a booster dose of Zabdeno.
Injections are given into the muscle around the shoulder (the deltoid) or a muscle of the thigh.
For more information about using Zabdeno, see the package leaflet or contact your doctor or pharmacist.
The active substance in Zabdeno will lead to the production of a viral protein found on Zaire ebolavirus. When a person receives the vaccine, the viral protein triggers an immune response. If later on the person comes into contact with the actual virus, the immune system recognises the viral proteins and is prepared to attack the virus, so protecting the person from the disease caused by Ebola virus.
Five main studies showed that Zabdeno, when used with Mvabea, can trigger the production of antibodies capable of providing protection against Zaire ebolavirus. The studies involved a total of 3,585 adults and children. Based on animal studies with a fully lethal dose of the virus, the antibody level generated in humans following vaccination with Zabdeno and Mvabea would be expected to lead to around 53% survival if infected with a fully lethal dose. However, the method used in the animal studies results in more severe infection than natural infection in humans. Although the vaccine regimen can provide protection against Ebola virus disease, the level and duration of protection are not yet known and the company will provide further data.
The most common side effects in adults with Zabdeno (which may affect more than 1 in 10 people) are pain, warmth and swelling at the injection site, tiredness, headache, muscle pain, joint pain and chills.
In children and adolescents aged 1 to 17 years, the most common side effects (which may affect more than 1 in 10 people) are pain at the injection site, tiredness, decreased activity, decreased appetite and irritability.
For the full list of side effects and restrictions of Zabdeno, see the package leaflet.
Zabdeno, used with Mvabea as part of a 2-dose vaccine regimen, triggers an immune response that can provide protection against Ebola virus disease. Although the level and duration of protection against the virus have not yet been determined, the European Medicines Agency considered that the vaccine’s benefits could be of great importance to help control an outbreak and prevent death. Regarding safety, most side effects are mild to moderate in severity and of short duration. The Agency therefore decided that Zabdeno’s benefits are greater than its risks and it can be authorised for use in the EU.
Zabdeno has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about Zabdeno for scientific and ethical reasons. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Since Zabdeno has been authorised under exceptional circumstances, the company that markets Zabdeno will provide an update on the collection of data on the effectiveness of the vaccine regimen in the intended population on a yearly basis.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zabdeno have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zabdeno are continuously monitored. Side effects reported with Zabdeno are carefully evaluated and any necessary action taken to protect patients.
Zabdeno received a marketing authorisation under exceptional circumstances valid throughout the EU on 01 July 2020.
Product information
Latest procedure affecting product information: 005337
20/07/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Zabdeno
- Active substance
- Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain
- International non-proprietary name (INN) or common name
- ebola vaccine (Ad26.ZEBOV-GP [recombinant])
- Therapeutic area (MeSH)
- Hemorrhagic Fever, Ebola
- Anatomical therapeutic chemical (ATC) code
- J07
Pharmacotherapeutic group
VaccinesTherapeutic indication
Active immunization for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ? 1 year of age.
News on Zabdeno
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