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ERVEBO (vaccin contre Ebola Zaïre, vivant atténué)

Vaccine
Opinions on drugs - Posted on Mar 02 2020

Reason for request

First assessment

  • Key points

Favourable opinion for reimbursement in the prevention of Ebola Virus Disease (EVD) caused by Zaire Ebola virus in populations in whom vaccination is recommended.

  • What therapeutic improvement?

A therapeutic improvement in the strategy for the prevention of Ebola Virus Disease (EVD) caused by Zaire Ebola virus recommended by current national guidelines.

  • Role in the care pathway?

According to current national guidelines, ERVEBO (Ebola Zaire vaccine, live attenuated) can be used in the context of its MA in individuals 18 years of age or older, in the following situations:

- for professionals liable to be exposed to the virus;

- for the post-exposure vaccination of contacts following the declaration of a case on the national territory.

Role of the medicinal product in the care pathway

ERVEBO (Ebola Zaire vaccine, live attenuated) can be used in accordance with its MA in the context of these recommendations.


Clinical Benefit

Substantial

The clinical benefit of ERVEBO (Ebola Zaire vaccine, live attenuated) is substantial in the prevention of EVD caused by Zaire Ebola virus in populations in whom vaccination is recommended.


Clinical Added Value

major

Considering:

  • the demonstrated major efficacy of ERVEBO in the prevention of Ebola Virus Disease (EVD) caused by Zaire Ebola virus, estimated to be 100%, 95% CI [63.5%; 100%], p = 0.0471 in the main study available,
  • the response to the medical need provided in a generally fatal disease, as the first vaccine to have an MA in France in this indication,

and despite:

  • the uncertainties, in particular with respect to the duration of protection provided,
  • the safety signals that will be the subject of additional monitoring in the context of national pharmacovigilance monitoring (arthralgia and arthritis, skin rash, transient decrease in white cells and risk of vaccine virus transmission),

the Committee considers that ERVEBO (Ebola Zaire vaccine, live attenuated) corresponds to a medicinal product with a new action mechanism having demonstrated a superiority, with a high level of evidence, associated with a clinically relevant effect in terms of morbidity and mortality in a context of an inadequately met medical need for a serious disease. ERVEBO therefore provides a major clinical added value (CAV I) in the prevention of Ebola Virus Disease (EVD) caused by Zaire Ebola virus recommended by current national guidelines.


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