Immunization standards

General notes for the WHO list of prequalified vaccines

  • This list is updated regularly. Vaccines are added to the list after a positive outcome of an evaluation of relevant data and relevant manufacturing sites are audited by WHO. When a vaccine is added to the list this means it: (i) meets the WHO recommended standards specified at http://www.who.int/entity/biologicals/areas/vaccines/en/index.html; (ii) is in accordance with the operational specifications for packaging and presentation required by UN organizations interested in procuring the vaccines in question; and (iii) and is suitable for the target population, at the recommended immunization schedules, and for use with appropriate concomitant products. The aforesaid recommended standards include independent and appropriate regulatory oversight of the vaccine by a responsible functional national regulatory authority (NRA).

  • WHO cannot represent that the listed vaccines and manufacturing sites will continue to meet the aforesaid standards and/or operational specifications. WHO may suspend or remove vaccines from the list based on information that may subsequently become available to it (including information on failure of the responsible NRA to exercise independent and appropriate regulatory oversight).

  • The list is not an exhaustive list of vaccines used to immunize humans. It reflects those vaccines which, following a selection based on immunization priorities set by relevant UN agencies and WHO, have been submitted to WHO for evaluation by interested parties and have - at the time of evaluation and audit - been found to meet the above mentioned WHO recommended standards and operational specifications.

  • The fact that certain vaccines are not included in the list does not mean that, if evaluated, they would not be found to comply with the above mentioned standards and operational specifications.

  • Vaccines included in the list are - subject to the terms of the prequalification procedure http://www.who.int/immunization_standards/vaccine_quality/pq_revised_procedure_final_1may2012.pdf - deemed acceptable, in principle, for procurement by UN agencies. Inclusion in the list does not imply any approval by WHO of the vaccines and manufacturing sites in question (which is the sole prerogative of national regulatory authorities).

  • This list may not be used by manufacturers and suppliers for commercial or promotional purposes.

  • Any UN organization intending to use the list of prequalified vaccines for procurement should ensure that only vaccines from the manufacturers mentioned in this list are supplied to it.

  • Procurement organizations using this list for procurement should perform other aspects of qualification prior to purchasing, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities, and other related aspects, including the registration status or other authorization of the vaccines they wish to procure.

  • This list does not constitute any guarantee for the procurement of the vaccines from the suppliers mentioned.

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Last update:

1 May 2012 14:55 CEST