Journal article

Off-label use of vaccines

This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or “label”1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product label regarding the vaccine use can lead to confusion at the level of vaccinators and vaccinees and possibly result in lower compliance with national vaccination schedules. In particular, in many countries, the label may contain regulatory restrictions and warnings against vaccination of specific population groups (e.g. pregnant women) due to a lack of evidence of safety from controlled trials at the time of initial licensure of the vaccine, while public health authorities may recommend the same vaccine for that group, based on additional post-marketing data and benefit risk analyses.


  • English

Publication year









Journal article


  • Programme management


  • World Health Organisation (WHO)

Topic references


Achieving immunization targets with the comprehensive effective vaccine management (EVM) frameworkUNICEF, World Health Organization (WHO)2016GuidanceEnglish
Cold room temperature mapping studiesWorld Health Organization (WHO)2018GuidanceEnglish
EVM assessment tools and user guidesWorld Health Organization (WHO)2019RepositoryEnglish
EVM Global Data AnalysisWorld Health Organization (WHO)2018GuidanceEnglish
EVM Standard Operating Procedures (SOPs)UNICEF, World Health Organization (WHO)GuidanceEnglish, French
How to Develop a Continuous Improvement Plan (cIP)UNICEF, World Health Organization (WHO)2018GuidanceArabic, English, French
Immunization supply chain and logistics - A neglected but essential system for national immunization programmesWorld Health Organization (WHO)2014GuidanceEnglish, French
Off-label use of vaccinesPieter Neels et al.2017Journal articleEnglish
Perception of health workers on the use of 30-day temperature recordersWorld Health Organization (WHO)2018GuidanceEnglish
Perception of health workers on the use of remote temperature monitoring systemsWorld Health Organization (WHO)2018GuidanceEnglish
Solar direct-drive vaccine refrigerators and freezers2017GuidanceEnglish
System design approach to improve the immunization supply chainWorld Health Organization (WHO)2018GuidanceEnglish
Temperature monitoring study: a fully documented process to detect weaknesses in the supply chainWorld Health Organization (WHO)2018GuidanceEnglish
Vaccine Management HandbookUNICEF, World Health Organization (WHO)2015GuidanceFrench
WHO guidance note: Vaccine diluents, revision 2015World Health Organization (WHO)2015GuidanceEnglish, French
WHO policy on the use of opened multi-dose vaccine vials (2014 Revision)World Health Organization (WHO)2014GuidanceFrench

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Added on: 2019-04-08 16:29:18

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