Immunization, Vaccines and Biologicals

Vaccine and immunization quality and safety

Ensuring the safety and quality of vaccines is one of WHO’s highest priorities.

WHO works closely with national authorities to ensure that global standards are developed and made readily available to assess the quality, safety and immunogenicity of biological products including vaccines.

WHO provides advice to procurement agencies and countries on the acceptability, in principle of vaccines. This is done through a pre-qualification process which includes a thorough review of the evidence generated by the manufacturer on the efficacy, immunogenicity and safety of the product. It also includes a visit to the production site in close coordination with the national regulatory agency of the country where the production site is located.

WHO works with National Regulatory Authorities (NRAs) in countries which produce or procure vaccines to help them reach international quality standards for the release of vaccines

WHO works closely with national experts and authorities to support vaccine safety. It has also established the Global Advisory Committee on Vaccine Safety (GACVS), an independent advisory body that reviews the scientific evidence with regards to any type of issue relating to the safety of vaccine product.

The WHO strategy for the safe and appropriate use of injections worldwide has four objectives: (1) formulating national policies and plans for the safe and appropriate use of injections, (2) ensuring quality and safety of injection equipment, (3) facilitating equitable access to injection equipment and (4) achieving appropriate, rational and cost effective use of injections. Ensuring the safety of immunization related injections interests with that of injection safety. Further information on this area can be found below.