Module 9 2024
03/09/2024
Concluding Remarks (2)
⚫ Technical
– Data as for biotech/biological
– But as combination vaccines and include other components like adjuvants (which have own
production), technical data often complex
⚫ As such LCM is a significant supply challenge for Vx which is made more complex by long life cycles
⚫ Despite the challenges, vaccines are fantastic products to be involved with!
⚫ And they are evolving into new modalities and indications
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Vaccines are one of the greatest achievements of public health 1
1. MMWR 1999;48:241 – 243
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