Module 9 2024

03/09/2024

Vaccines are Becoming More Well-defined

mRNA/DNA

Recombinant protein

Live Recombinant Virus

More well defined = easier to characterize, new control strategies, less variability

Toxoid-Saccharide Conjugates

Inactivated Toxoid (protein)

Live Attenuated Virus/Bacteria

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Vaccines are Expanding into New Indications From Paediatric and Prophylactic

Allergy

Auto Immune

Older Adult

Requiring regulators to adapt to ensure expertise from x-disciplines is used to assess these new modalities Will challenge the current paradigm of a vaccine and its regulatory requirements

LEADING TO: Changes in clinical designs

Oncology

Adult

Accelerated development Rare disease indications Unmet Medical Needs

Nosocomial Infections

Adolescent

Infections (Therapy)

Bacterial/viral infections

Paediatric

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