Module 9 2024

03/09/2024

Specific Considerations for Vaccines

Non-Clinical and Clinical

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Non-Clinical and Clinical - Basic Features Dossier Section Basic Features relevant to a Prophylactic Vaccine

Need to demonstrate an immune response (+ efficacy assessment if animal models available)

PK data not needed (biodistribution study may be required on a case by case basis)

Non-clinical

Toxicological assessment required to demonstrate nonclinical safety prior to FTIH

Genotoxicity and carcinogenicity studies are typically not required

Developmental and reproductive toxicity (DART) studies are required unless children and women of child bearing potential are not included in the patient population

Measure immunogenicity – antibody levels and/or cell-mediated immunity

PK data not needed

Large safety database

Clinical

Protective efficacy : demonstrate that vaccine prevents infection / disease (may use immune correlate of protection)

Co-administration with licensed vaccines

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