Interim Statement on the Use of the rVSVΔG-ZEBOV-GP Vaccine for the Prevention of Ebola Virus Disease

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Organization: Public Health Agency of Canada

Date published: February 2020

An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI)

Summary of information contained in this NACI statement

The following highlights key information for vaccine providers. Please refer to the remainder of the interim statement for details. The full-text of the interim statement is available in PDF format. To obtain the report in an alternative format, please contact us by email at phac.naci-ccni.aspc@canada.ca.

What

Merck’s investigational rVSVΔG-ZEBOV-GP vaccine (also referred to as the V920 Ebola Zaire Vaccine and Ervebo) is a live-attenuated, recombinant vesicular stomatitis virus (rVSV)-based vector vaccine against Zaire ebolavirus (ZEBOV). A limited quantity of this pre-market vaccine is stockpiled in Canada’s National Emergency Strategic Stockpile (NESS). This vaccine does not currently have Health Canada authorization for sale in Canada and has been imported through Health Canada’s Special Access Programme.

Who

This interim advisory committee statement addresses the emergency use of the pre-market rVSVΔG-ZEBOV-GP vaccine stockpiled in the NESS for protection against Ebola virus disease (EVD) caused by ZEBOV infection. The interim recommendations include use in non-pregnant immunocompetent adults; pregnant women; infants, children, and adolescents; and immunocompromised individuals.

How

NACI makes the following interim recommendations for post-exposure prophylaxis against ZEBOV for the pre-market rVSVΔG-ZEBOV-GP vaccine stockpiled in the NESS:

NACI recommends that the pre-market rVSVΔG-ZEBOV-GP vaccine stockpiled in the NESS may be considered as pre-exposure prophylaxis against ZEBOV for non-pregnant immunocompetent adults in exceptional situations when a dedicated team of healthcare workers is anticipated to provide direct care for a confirmed case with symptomatic ZEBOV infection, if vaccine is available.

Why

EVD is a rare, severe, acute viral illness with a case fatality rate in humans ranging from 25–90%. Although uncertainties around safety, immunogenicity, efficacy, and effectiveness remain, vaccination with the rVSVΔG-ZEBOV-GP vaccine currently offers the best available protection against EVD caused by ZEBOV infection given the potential for severe harm from EVD and few options for reducing case fatality. The rVSVΔG-ZEBOV-GP vaccine has shown few serious adverse events, despite a high degree of reactogenicity, and is immunogenic in non-pregnant immunocompetent adults. The vaccine has been shown to be efficacious in preventing EVD in the context of community outbreaks, if symptoms of EVD did not appear within 10 days of vaccination.

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