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.
Efficient means to determine Hib component in liquid vaccine presentations, for different vaccines, produced by different manufacturers.
The WHO Prequalification of Vaccines Programme (PQV) published the results of a small study to test five selected vaccines, using two different test protocols and two reference standards. A collaborative study is now planned, whereby a broader range of control laboratories (NCLs and manufacturers) will apply and verify the test protocol.
- Efficient means to determine Hib component in liquid vaccine presentations, for different vaccines, produced by different manufacturers.
Twelfth WHO/UNICEF consultation with OPV/IPV manufacturers and NRAs
The twelfth WHO/UNICEF consultation meeting with OPV/IPV manufacturers and national regulatory authorities (NRAs) took place on 10 October 2013 at WHO/HQ, Geneva.
Oral Poliomyelitis Vaccine (OPV): Questions and Answers - production, control and prequalification process
Oral Poliomyelitis Vaccine (OPV) Questions and Answers (Q&A) - production, control and prequalifcation process (PQ)
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.
- Clinical considerations for evaluation of vaccines for prequalification.
- Environmental monitoring of clean rooms in vaccine manufacturing facilities
Guide to Master Formulae
- Guidance on variations to a prequalifed vaccine
- Deviation handling and quality risk management
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.
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.
agenda - day 1
agenda day 2 - medicines
agenda day 2 - vaccines
Programme update - Prequalification of vaccines
Update of the procedure for WHO vaccines prequalification
Procedure for the expedited review of imported prequalified vaccines with view to granting a marketing authorization
New approach to investigation of complaints and AEFIs report
Vaccine standardization in the context of prequalification
Integration of Influenza vaccine evaluations to the main stream prequalification procedure
Need for improved post-marketing surveillance in receiving countries and suggestions on how to monitor safety of newly introduced vaccines
List of participants
- Prequalification of Medicines Programme and Prequalification of Diagnostics Programme - more information
Article 58 scientific opinion procedure - guideline on procedural aspects regarding a CHMP scientific opinion in context of cooperation with WHO for the evaluation of medicinal products intended exclusively for markets outside the european community.
Technical review of vaccine vial monitor implementation
- Further information on Poliomyelitis including guidelines for safe production and quality control of IPV
- Vaccine safety homepage
- Vaccine safety topics - thiomersal and vaccines
- SAGE conclusions and recommendations
- Guidelines on the international packaging and shipping of vaccines (WHO/V&B/05.23) [pdf 498kb]