Vaccine quality and safety


WHO supports countries in ensuring the quality and safety of vaccination through the strengthening of their national regulatory authorities (NRA) dealing with vaccines and particularly the surveillance of adverse events following immunization (AEFI).

National regulation

The primary objective is to ensure that countries use vaccines that meet global norms and standards. WHO/Europe supports Member States in performance evaluations and capacity building for NRA. The role of the NRA is mainly to establish a regulatory framework for the use of locally produced and/or imported vaccines, to ensure their quality, potency and safety. The NRA have six main functions: licensing, post-marketing surveillance, lot release, laboratory testing, good manufacturing practices and clinical evaluation.

Prequalified vaccines

Countries that do not have the resources fully to implement the licensing of vaccines should procure those vaccines that are WHO prequalified and proceed with fast track registration as described in the newly published guidelines “Procedure for expedited review of imported pre-qualified vaccines for use in national immunization programmes (WHO/IVB/07.08)”.

Quick response in the event of abnormalities 

The surveillance of AEFI is a critical monitoring function to be closely implemented by NRA and immunization programmes. Although adverse events are very rare, surveillance allows programmes to detect abnormalities in the vaccine or programme errors. This is of utmost importance during vaccination campaigns such as measles-rubella supplementary immunization activities, when a large number of doses are administered in a short time.

WHO established the Global Advisory Committee on Vaccine Safety (GACVS) to respond promptly, efficiently and with scientific rigour to vaccine safety issues.