Guidance

Off-label vaccine use: explanatory note for countries

World Health Organization (WHO)

The document explains what off-label use of a vaccines is, why SAGE makes off-label recommendations and describes considerations for countries when using a vaccine off-label.  

Authors

Languages

  • English

Publication year

2024

Type

Guidance

Categories

  • Vaccines & delivery devices

Diseases

  • Mpox

Organisations

  • World Health Organization (WHO)

Mpox-Policy

This resource appears in the following Hot Topic page:

The resource is included in the following table:

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

The resource is included in the following table:

TitleAuthorYearTypeLanguage
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
Note de synthèse: position de l’OMS sur les vaccins contre la variole et la mpox (orthopoxvirus)World Health Organization (WHO)2024GuidanceFrench, 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
Regulatory & Policy Considerations for Mpox Vaccines in African CountriesWorld Health Organization (WHO), European Medicines Agency, Bavarian Nordic2025PresentationEnglish
Vaccin LC16m8 (‎vaccin lyophilisé vivant atténué)‎ contre la variole et la variole du singe : directives provisoiresWorld Health Organization (WHO)2025GuidanceFrench, English

Added by: Géraldine Nemrod

Added on: 2024-11-19 15:07:53

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