Draft guidance on reporting variations to a prequalified vaccine
A revised procedure for WHO prequalification of vaccines was endorsed by the WHO's Expert Committee on Biological Standardization (ECBS) in October 2010.
After the prequalification of a vaccine, manufacturers may introduce or plan to introduce changes in the manufacturing of the product. These changes are made to a vaccine that has been licensed by the National Regulatory Authority (NRA) of the producing country and also has been prequalified by WHO for global use. Many of these changes are introduced to improve the quality profile of the vaccine, the efficiency of the manufacturing process, to alter the labelling, the scheduling, or they could be made for marketing reasons.
Changes may have implications and impact on the quality, safety and efficacy of the vaccines, therefore NRAs have developed and published schemes to classify these changes. WHO is currently developing new guidelines on regulation of post approval changes to vaccines.
In the context of the revised prequalification procedure (Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies, WHO/BS/10.2155), a system is needed to ensure that all important variations are reported and assessed not only by the responsible NRA but also by the Prequalification Secretariat at WHO.
WHO is currently developing two new documents on post-approval changes. Both documents are specific for vaccines but their objective, scope and target users are different. These are the two WHO documents:
- Guidelines for procedures and data requirements for changes to approved vaccines.
- Guidance on reporting variations to a prequalified vaccine.
The first document is addressed to assist National Regulatory Authorities in the development of national requirements to deal with the post-approval changes to vaccines while the second is intended for manufacturers of prequalified vaccines to guide them on how and when to report variations that, in the majority of cases, have already been reviewed and approved by the local NRA. Therefore, these two documents complement each other.
The document "Draft guidance on reporting variations to a prequalified vaccine" is now posted for comments. It is intended as a guidance to manufacturers of prequalified vaccines, and as a complement to the "Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies (WHO/BS/10.2155)". It provides the basis for the reporting of variations introduced to prequalified vaccines and how these should be reported to the Prequalification Secretariat at WHO. Where variations are not described in this guidance case-by-case basis will be adopted, and manufacturers are advised to discuss such changes with the Prequalification Secretariat at WHO.
The WHO Prequalification Secretariat invites comments from manufacturers of prequalified vaccines as well as from those with products in the pipeline for WHO submission. Comments to this first draft should be addressed to dominguezmorales@who.int and dellepianen@who.int by 29 March 2013.
WHO acknowledge the support of USAID to prepare this document.