Importation of doses of V920 for Emergency Use

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Study title: 
Importation of doses of V920 for Emergency Use
Long title: 
Import in Belgium of doses of a vaccine candidate for protection against Ebola Virus Disease (EVD), for use in vaccination of health care workers traveling to Africa under Emergency Use conditions to support outbreak situations in Africa
Date receipt dossier: 
20 Jun 2019
EU record number: 
B/BE/19/BVW4
Company / Sponsor: 
Merck Sharp & Dohme B.V.
Phase: 
Deliberate release
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
Ebola Virus Disease (EVD)
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
Method of transfer of nucleic acid of interest: 
Vesicular Stomatitis Virus (rVSV)
Administered biological material: 
The vaccine is a genetically modified (GM), replication-competent, attenuated live virus
Route of administration: 
Intramuscular
Locations in Belgium: 
CHU Saint-Pierre (Brussels)
Nr of subjects: 
About five health care workers should be vaccinated per week
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized
Notes: 
The V920 candidate vaccine is currently being deployed under ring vaccination using the Expanded Access/Compassionate Use protocol as recommended by WHO Strategic Advisory Group of Experts. V920 is also currently under regulatory review by the European Medicines Agency (EMA) for active immunization of at-risk individuals 18 years of age and older to protect against Zaire Ebola virus disease (Marketing Authorisation Application according to Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency). Awaiting authorization from EMA, Médecins Sans Frontières (MSF) requested to receive doses of V920 in Belgium to support vaccination of local health care workers to be deployed in the DRC, where an outbreak of Ebola virus disease is currently ongoing. MSD plans to ship V920 doses from the United States to a reference hospital in Brussels where the vaccination will take place. About five health care workers should be vaccinated per week. After the vaccination, the patient should stay for 30 minutes under surveillance and then leave the reference hospital without quarantine measures. The health care workers will then be deployed to the field in an epidemic zone, sometimes already within 48 hours of vaccination.

Information related to the decision procedure