Chapter 22: Assuring the quality, safety and efficacy of HPV vaccines: the scientific basis of regulatory expectations pre- and post-licensure.
The potential of human papillomavirus (HPV) vaccines will only be realized if the vaccine candidates under development prove to be safe and effective and can be consistently produced to define quality standards. Whilst the responsibility for delivering a safe and effective product rests with the vaccine producer, a vaccine requires a license to allow it to be placed on the market. Licensure is based on an evaluation of the safety and efficacy profile of a vaccine candidate by national regulatory authorities, ideally on the basis of internationally agreed, science-based specifications and procedures. For vaccines, these international specifications are developed by the World Health Organization (WHO). The scientific basis for the regulatory evaluation of the safety and efficacy of HPV vaccines is described in this paper. Once a vaccine is licensed, a second set of criteria are evaluated by a different group of experts to provide advice to national health policy decision makers as to whether the vaccine should be introduced into national immunization programmes. Factors, such as evidence of high disease burden and high cost-effectiveness are taken into account in this second decision-making process.
Wood
David
D
Department of Immunizations, Vaccines and Biologicals, World Health Organization, Avenue Appia, Geneva, Switzerland. woodd@who.int
Shin
Jin-Ho
JH
Duval
Bernard
B
Schmitt
Heinz-Joe
HJ
D006801:Humans; D008004:Licensure; D053918:Papillomavirus Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards
D053918:Papillomavirus Vaccines