Archived: Interim Statement on the Use of the rVSVΔG-ZEBOV-GP Vaccine for the Prevention of Ebola Virus Disease
Organization: Public Health Agency of Canada
Date published: February 2020
On November 9, 2022, Health Canada authorized the use of Ervebo® for the active immunization of individuals 18 years of age and older to protect against Ebola Virus Disease (EVD) caused by the Ebola virus (EBOV) (Orthoebolavirus zairense formerly Zaire ebolavirus). For complete prescribing information, consult the product leaflet or information contained within the Health Canada authorized product monograph available through the Drug Product Database.
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 firstname.lastname@example.org.
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 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.
NACI makes the following interim recommendations for post-exposure prophylaxis against ZEBOV for the pre-market rVSVΔG-ZEBOV-GP vaccine stockpiled in the NESS:
- The vaccine should be offered to non-pregnant immunocompetent adults who have had an exposure to ZEBOV in Canada; and
- The vaccine may be considered for pregnant women, infants, children, adolescents, and immunocompromised individuals who have had an exposure to ZEBOV in Canada.
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.
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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