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.


Determination of total and free saccharide content in liquid formulations: a challenge for laboratories and manufacturers

Hands-on laboratory training course held in Rome, Italy: additional courses to follow

The first hands-on-training course to develop skills for applying a test protocol using high-performance anion exchange chromatography pulsed amperometric detection (HPAEC-PAD) to determine the total and free saccharide content of Haemophilus influenzae type b liquid combined vaccines, was held at the National Centre for Research and Evaluation of Immunobiologicals (CRIVIB) of the Istituto Superiore di Sanità (ISS), Rome (Italy) from 29 September to 3 October 2014. Two additional courses are planned and are fully booked, but further courses will be organized if demand is sufficient.


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.


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



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.



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:

16 December 2014 14:56 CET