Ervebo

Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

Opinion

On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation1 for the medicinal product Ervebo, intended for prophylaxis against Zaire Ebola virus disease (EVD). Ervebo was reviewed under EMA’s accelerated assessment programme. The applicant for this medicinal product is Merck Sharp & Dohme B.V.

Ervebo will be available as solution for injection. The active substance of Ervebo consists of a live attenuated recombinant Vesicular Stomatitis Virus (rVSV) with a deletion of the VSV envelope glycoprotein replaced with the Zaire Ebolavirus (ZEBOV) surface glycoprotein. Ervebo is a viral vaccine (ATC code J07BX02) that provides active immunisation against Zaire Ebolavirus by inducing an immune response that helps protect against the disease.

The benefits with Ervebo are its ability to prevent laboratory confirmed EVD based on clinical efficacy data gathered in individuals at risk of infection during an Ebola outbreak in West Africa. The most common side effects are injection-site reactions (pain, swelling and erythema), headache, pyrexia, myalgia, fatigue and arthralgia.

The full indication is: “Ervebo is indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebolavirus. The use of Ervebo should be in accordance with official recommendations”.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive data at a later stage.

Key facts

Name
Ervebo
Agency product number
EMEA/H/C/004554
International non-proprietary name (INN) or common name
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
Active substance
  • Recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit-1995) surface glycoprotein
Therapeutic area
Hemorrhagic Fever, Ebola
Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Date opinion adopted
17/10/2019
Status
Positive
Application type
Initial authorisation

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