Presentation

Regulatory & Policy Considerations for Mpox Vaccines in African Countries

In the African region, mpox vaccination was first rolled out by DRC in October 2024 as part of their overall strategy to stop active transmission. To date, four countries (DRC, Nigeria, Rwanda and CAR) have rolled out vaccination. Mpox vaccination, however, has been largely limited to adults above 18 years in the four countries as per the Emergency Use Authorization granted by the national regulatory authorities. This was mainly because the EUAs were granted when the evidence in children below 12 years was still limited. Other countries that are yet to start vaccination also have EUAs for use among adults 18 years and above.

As more evidence became available, The MVA-BN vaccine was authorized for use among children aged 12 years and above by the European Medicines Association (EMA) and subsequently prequalified by WHO for use among children 12 years and above. The WHO Strategic Advisory Group of Experts (SAGE) recommends the use of mpox vaccines among children at risk of exposure to mpox in outbreak settings when the benefits of vaccination outweigh the potential risks. 

Cases of mpox have been reported among children in many of the countries with mpox cases. To break chains of transmission and contribute to stopping the outbreak, there is need to vaccinate children who are at high-risk of mpox. This presentation shares updates on regulatory considerations on use of MVA-BN among children to facilitate countries to update their regulatory authorization.

Languages

  • English

Publication year

2025

Type

Presentation

Categories

  • Vaccines & delivery devices

Diseases

  • Mpox

Countries

  • Africa

Organisations

  • World Health Organization (WHO)

Tags

  • Emergencies
  • New vaccine introduction
  • Policy and legislation

WHO Regions

  • African Region

Mpox-Policy

You can find more information about "Mpox-Policy" in the following Hot Topics:

TitleAuthorYearTypeLanguage
Smallpox and mpox (orthopoxviruses): WHO position paperWorld Health Organization (WHO)2024GuidanceEnglish, French
Summary of WHO SAGE recommendations for mpox vaccines, including considerations for off-label useWorld Health Organization (WHO)2025PresentationEnglish
Off-label vaccine use: explanatory note for countriesWorld Health Organization (WHO)2024GuidanceEnglish
MVA-BN (‎Modified Vaccinia Ankara – Bavarian Nordic)‎ smallpox and mpox vaccine: Interim guidanceWorld Health Organization (WHO)2024GuidanceEnglish, French
ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of ageEuropean Medicines Agency2024GuidanceEnglish
Regulatory & Policy Considerations for Mpox Vaccines in African CountriesWorld Health Organization (WHO), European Medicines Agency, Bavarian Nordic2025PresentationEnglish
LC16m8 (live-attenuated freeze-dried vaccinia) smallpox and mpox vaccine - Interim GuidanceWorld Health Organization (WHO)2025GuidanceEnglish, French
Frequently Asked Questions (FAQ) on use of fractional dosing with intradermal administration of mpox MVA-BN vaccine in the context of vaccine supply-constrained outbreak responseWorld Health Organization (WHO)2025GuidanceEnglish

Mpox-Policy-FR

TitleAuthorYearTypeLanguage
Note de synthèse: position de l’OMS sur les vaccins contre la variole et la mpox (orthopoxvirus)World Health Organization (WHO)2024GuidanceFrench, English
Vaccin LC16m8 (‎vaccin lyophilisé vivant atténué)‎ contre la variole et la variole du singe : directives provisoiresWorld Health Organization (WHO)2025GuidanceFrench, English
Vaccin contre la variole et la mpox MVA-BN (‎Modified Vaccinia Ankara - Bavarian Nordic)‎ : directives provisoiresWorld Health Organization (WHO)2024GuidanceFrench, English
ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of ageEuropean Medicines Agency2024GuidanceEnglish
Off-label vaccine use: explanatory note for countriesWorld Health Organization (WHO)2024GuidanceEnglish
Regulatory & Policy Considerations for Mpox Vaccines in African CountriesWorld Health Organization (WHO), European Medicines Agency, Bavarian Nordic2025PresentationEnglish
Summary of WHO SAGE recommendations for mpox vaccines, including considerations for off-label useWorld Health Organization (WHO)2025PresentationEnglish

Added by: Miluka Gunaratna

Added on: 2025-02-11 12:17:41

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