Immunization standards

Vaccine manufacturers' corner

This part of our website was created to update our partners involved in the development of vaccines on strategies, policies, decisions and recommendations that would be of interest to them.

Draft guidance on reporting variations to a prequalified vaccine - for comments by 29 March 2013

The document "Draft guidance on reporting variations to a prequalified vaccine" is now posted for comments.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.

Eleventh WHO/UNICEF consultation with OPV/IPV manufacturers and NRAs

The eleventh WHO/UNICEF consultation meeting with OPV/IPV manufacturers and national regulatory authorities (NRAs) took place on 25 October 2012 at WHO/HQ, Geneva. The objectives of the meeting were:

  • To update manufacturers and NRAs on the current status of the global polio emergency action plan for both WPV eradication and cVDPV elimination;
  • To inform manufacturers on projected tOPV, bOPV1&3, mOPV1, mOPV3 and IPV demand for the period 2013-2016;
  • To bring manufacturers and NRAs up-to-date on pre & post-eradication risk assessment and the ongoing research and programme of work to develop appropriate policies and products for managing these risks (including new developments in the elaboration of pre and post-eradication IPV policy); and
  • To strengthen existing collaboration between manufacturers and NRAs involved in the Global Polio Eradication Initiative.

Oral Poliomyelitis Vaccine (OPV): Questions and Answers - production, control and prequalification process

UN Prequalification of Medicines, Diagnostics and Vaccines - Sixth consultative stakeholder meeting and second meeting with manufacturers, 4-5 April 2011, Geneva

The WHO Prequalification of Medicines Programme (PQP), in conjunction with the Prequalification of Vaccines Programme and the Prequalification of Diagnostics Programme, organized the Sixth Consultative Meeting with Stakeholders and the Second Meeting with Medicine Manufacturers. The meetings were held in Geneva on 4 and 5 April 2011.

Detailed information about the meetings may be found below.

Points to consider for manufacturers of human vaccines

In response to a request from the Developing Country Vaccine Manufacturers Network (DCVMN) to provide more technical guidance to manufacturers wishing to submit vaccines for prequalification for supply to UN agencies, WHO has decided to produce a series of points to consider documents to help clarify WHO requirements to vaccine manufacturers and help harmonize interpretations among assessors.

These documents intend to provide specific technical clarification but without contradicting existing standards published in the WHO Technical Report Series and because no such guidance is currently available, will be published for general use and not just for prequalified vaccines.

Working Group meeting on oral poliomyelitis vaccines

The Working Group meeting on oral poliomyelitis vaccines: Revision to the current WHO Recommendations, was held at WHO, Geneva, Switzerland from 20 to 22 July 2010.

Trypsin in OPV and other vaccines

In the framework of the campaign to eradicate poliomyelitis, the quality and safety of Oral Polio Vaccines used for mass immunization is permanently being scrutinized and questioned by some customers or associations. Recently, concerns have been raised by Muslim communities in relation to the presence of a product derived from pig (the trypsin) which is used in the production of OPV and other vaccines manufactured in cell cultures.
In July 2003, the Session of the European Council of Fatwa and Research issued a statement addressed to Muslim leaders encouraging them to take into account the considerable benefits brought by OPV to Muslim children and encourage them to focus on the benefits for the future of their children.

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Last update:

28 February 2013 16:32 CET