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

Diseases

Organisations

Mpox-Policy

This resource appears in the following Hot Topic page:

The resource is included in the following table:

TitleAuthorYearTypeLanguage
ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of ageEuropean Medicines Agency2024GuidanceEnglish
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
LC16m8 (live-attenuated freeze-dried vaccinia) smallpox and mpox vaccine - Interim GuidanceWorld Health Organization (WHO)2025GuidanceEnglish, French
MVA-BN (‎Modified Vaccinia Ankara – Bavarian Nordic)‎ smallpox and mpox vaccine: Interim guidanceWorld Health Organization (WHO)2024GuidanceEnglish, French
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
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

Mpox-Policy-FR

The resource is included in the following table:

TitleAuthorYearTypeLanguage
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
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
Note de synthèse: position de l’OMS sur les vaccins contre la variole et la mpox (orthopoxvirus)World Health Organization (WHO)2024GuidanceFrench, English
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
Vaccin LC16m8 (‎vaccin lyophilisé vivant atténué)‎ contre la variole et la variole du singe : directives provisoiresWorld Health Organization (WHO)2025GuidanceFrench, English
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Added by: Géraldine Nemrod

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

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