Bibliographic Info
GuidelineGuidelines for the management of pregnant and breastfeeding women in the context of Ebola virus disease
Year of Publication2020
Issuing InstitutionWHO
Recommendation
Status
Maintained
Recommended in favor
Conditional
Certainty of evidence
Very low
Pregnant and breastfeeding women should be offered vaccination with the prequalified Ervebo (Merck) live-replicating rVSV-ZEBOV-GP vaccine during an active Zaire Ebola virus outbreak in affected areas, in the context of rigorous research or in accordance with a compassionate use protocol. Vaccination should occur with informed consent and in compliance with good clinical practice
Notes and Remarks
- 1.The WHO prequalified the injectable Ebola vaccine Ervebo (manufactured by Merck) in November 2019 after the vaccine was deemed compliant with WHO standards for quality, safety and efficacy. This decision followed the European Medicines Agency (EMA) announcement recommending a conditional marketing authorization for the rVSV-ZEBOV-GP vaccine.
- 2.The Strategic Advisory Group of Experts (SAGE), the principal advisory group to WHO on vaccinations, recommends that pregnant and lactating women be included in research within the framework of clinical trial vaccine protocols. SAGE notes that protocols must include provisions for safety monitoring and documentation of EVD cases among vaccinated individuals, as well as follow-up of pregnant women and their offspring.
- 3.The MEURI expert panel recommends that “access to and use of investigational therapeutics under MEURI be carefully considered for each individual patient, including for vulnerable populations such as pregnant women and paediatric patients, as appropriate given the available data”. In general, the expert panel recommends that factors including disease severity, available information on risks and benefits for the investigational therapy (including any available information on adverse effects in pregnancy or paediatrics) be considered.
- 4.There are no available studies that have determined the efficacy of rVSV-ZEBOV-GP vaccine in pregnant women; however, the vaccine is considered to have very good efficacy in the general population
Also Featured In
This recommendation also appears in the following guidelines:
Guideline
WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee, second edition. Geneva: World Health Organization; 2025
Year2023
InstitutionWorld Health Organization