History

WHO established the Expanded Programme on Immunization (EPI) in the late 1970s to ensure that all children everywhere benefit from life-saving vaccines. An increasing number and range of vaccines were being procured and distributed by UN agencies and they had to ensure that these products were consistently safe and effective under conditions of use in national immunization programmes. In response, in 1987, WHO developed requirements and a procedure for the prequalification of vaccines. The procedure consisted of a review of production consistency and a manufacturing site inspection.

The procedure to assess the acceptability of candidate vaccines for the United Nations was published in 1989, in the thirty-ninth report of the WHO Expert Committee on Biological Standardization (ECBS). In 1992, the Forty-fifth World Health Assembly stipulated that all vaccines used in national immunization programmes should meet WHO requirements.

Since 2000, the diversity and complexity of vaccine products submitted for prequalification has increased significantly. In parallel, demand for vaccines continued to grow and programmatic needs evolved. The demand for investigation into potential safety and quality issues also increased, exerting greater pressure on WHO resources.  The vaccines prequalification procedure was therefore revised.

Important procedural changes were introduced, notably:

• increased collaboration with NRAs and greater reliance on information generated by NRAs during their product evaluations
• definition, codification and communication to manufacturers of the specifications for critical and desirable vaccines characteristics for immunization programmes.

These procedural changes have resulted in a reduction in prequalification assessment timelines for manufacturers while improving the suitability of prequalified vaccines for national immunization programmes and their target populations.

In 2012, in response to the significant increases in the volumes, cost and also sensitivity of a new generation of more effective vaccines, a streamlined procedure for prequalification was developed to further reduce assessment timelines and make best use of limited resources. The procedure:

• recognizes the regulatory assessment and inspection reports and test results for vaccines approved in Australia, Belgium, Canada, France, Italy, or the United States, or by the European Medicines Agency under Article 58, thereby eliminating duplicative regulatory activity
• incorporates review of the manufacturer's Vaccine Product Annual Reports for each prequalified vaccine
• introduced a risk-based re-assessment schedule that considers level of NRA functionality, quality control test results, complaints and adverse events history, and the number and scope of variations made to a product, thereby focusing prequalification resources where they are most needed.

Demand for vaccines continued to grow and programmatic needs evolved. The vaccines prequalification procedure was therefore revised. As of 2002, the national regulatory authority (NRA) of the producing country of any product submitted by a manufacturer for evaluation for prequalification must previously have been assessed as “functional" by WHO. This revision served to revolutionize the impact of WHO efforts to strengthen vaccine regulation capacity in developing countries. And in 2012, in response to the significant increases in the volumes, cost and also sensitivity of a new generation of more effective vaccines, a streamlined procedure for prequalification was developed to reduce assessment timelines and make best use of limited resources. The procedure:

• recognizes the regulatory assessment and inspection reports and test results for vaccines approved in Australia, Belgium, Canada, France, Italy, or the United States, or by the European Medicines Agency under Article 58, thereby eliminating duplicative regulatory activity
• incorporates review of the manufacturer's Prequalified Vaccine Annual Report
• introduced a risk-based re-assessment that considers level of NRA functionality, the information provided in the Prequalified Vaccine Annual Report on quality control test results, complaints and adverse events history, and the number and scope of variations made to a product, thereby focusing prequalification resources where they are most needed.

Mission and vision

The vision of WHO vaccines prequalification is of a world in which every child, man and woman has access to the quality medicines they need to lead a healthy and productive life.

The mission of WHO vaccines prequalification is to advise UN procurement agencies, immunization programmes, NRAs and national control laboratories (NCLs), as well as with vaccine manufacturers and a range of organizations and networks, to enable WHO Member States to access quality and reliable vaccines that meet their programme needs.

Key outputs

The key outputs of vaccines prequalification are:

• the WHO List of WHO Prequalified Vaccines
• the list of laboratories that are qualified to test for vaccine compliance with WHO standards as a part of the prequalification process
• investigation reports of any complaints from the field or AEFIs
• WHO Public Assessment Reports
• WHO Public Inspection Reports
• guidance documents regarding the WHO process for vaccines prequalification.