24 – Understanding vaccine development, manufacturing, regulation and procurement

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This session provided an excellent overview of some of the key stages from vaccine development to supply

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Copyright GAVI/2007

Immunizing a child is the result of more than a decade of work and hundreds of millions of dollars of investments. It is the result of a complex process from development to regulatory approval, procurement and delivery of new vaccines. It is important for countries to understand the various steps, why they take the time they do, costs, and chances of problems or failure along the way, particularly in the context of increasing supply and demand for new vaccines.

This session provided an excellent overview of some of the key stages from vaccine development to supply.

The overwhelming message emphasised by all speakers is that vaccines are complex.

Firdausi Qadri from ICDDR,B began by providing an overview of the challenges associated with vaccine development, particularly emphasising the variability in timelines for development and efficacy of vaccines in different settings.

Mahima Datla provided a compelling insight into vaccine manufacturing summarising her main take home message as “the need to remember that vaccine manufacturing involves significant fixed costs, and that many vaccines, especially inactivated vaccines, also contain very high variable costs. Some vaccines, such as Pentavalent, can take as long as 7.5 months to manufacture.

Meredith Shirey explained that UNICEF purchases approximately 2.5 billion doses of vaccines on an annual basis, working with 46 different vaccines for about 100 countries.

Purchases from emerging markets are increasing, but supply challenges, such as those recently experienced with Pentavalent, remain an ongoing challenge for UNICEF, countries and other stakeholders.

The final presenter, Hiiti Sillo, provided an overview of regulatory practices in Tanzania as well as the positive harmonisation initiatives developing in the African region for vaccine regulation.

The session concluded with many participants expressing their appreciation for the high quality presentations and there was strong agreement on the need to further expand knowledge and understanding of these complex processes among the broader immunisation community.


GAVI support will assist countries to immunise a further 243 million children from 2011 to 2015.

GAVI Alliance

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