Module 9 2021

23/03/2021

A significant challenge for vaccines Life Cycle Management

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Why do Vaccines Present Greater LCM Challenges?

Complex biological products

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● May be composed of one of more antigens in combination , with unique molecular structures presented in a final formulation with an adjuvant of varying compositions ● Update of new variants – e.g. Flu and Covid? ● Very long life cycles (e.g. vaccines for Measles-Mumps-Rubella, Hepatitis recombinant B) ● As a result, many vaccines were registered decades ago but are still maintained and used to immunise millions of people today ● Together, this means that – vaccines require submission of many variations or supplements over many years – and, because they are combination products or use the same adjuvant, changes are often repeated across multiple product licences

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