Immunization standards

Priority setting for WHO vaccine prequalification

Priorities for vaccine evaluations for prequalification for 2015-2016

The prioritization list below is a tool published every two years by the WHO prequalification programme to guide decisions as to the vaccines on which to focus resources. Vaccines are categorized in four groups: high, medium, low and no priority. At each dossier submission deadline, WHO will accept for evaluation vaccine applications in any of the first three groups as long as the resources are sufficient to evaluate them. If the number of applications exceeds the capacity at WHO, vaccines will be taken up for evaluation according to the assigned priority. Evaluation of applications for vaccines in the lowest priority group may be postponed to the subsequent deadline. Applicants will be informed accordingly. Within the same category, applications will be considered for evaluation in order of receipt. A vaccine with no priority will not be accepted for evaluation.

The priority list was developed by consultation between WHO and the two United Nations purchasing agencies (UNICEF and the Pan American Health Organization Revolving Fund) which use the prequalification service for vaccines. The prioritization exercise takes into account needs from WHO programmes (e.g. polio, measles, rabies) and the International Health Regulations, as well as vaccines defined globally as priority for accelerated introduction. In the consultation process for the current list, vaccines were considered if, based on information available to the UN purchasing agencies and WHO, they were already available in the market or were expected to become available during the biennium 2015-2016. The criteria used to assign priorities are given below. Applications for vaccines under development that are of high programmatic interest ( e.g new formulations of current vaccine types with enhanced stability outside of the currently-accepted storage conditions) will be considered for evaluation if they become available for supply before the end of 2016. Other vaccines in the research pipeline, and not expected to become available for supply during the biennium, are not included in the prioritization list.

Criteria used for decision-making

a) Demand in the respective UN-supplied markets, with consideration given to plans for introduction;
b) WHO programmatic needs (e.g. to comply with International Health Regulations; to comply with eradication, elimination or control initiatives; to comply with immunization programme considerations);
c) recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization ; and
d) security of supplies: number, diversity, and production capacity of suppliers in the market.

Important note for manufacturers

There are three deadlines for submission of applications to WHO. These are 31 January, 31 May and 30 September of each year.

Last update:

6 April 2016 14:28 CEST