Module 9 2024

03/09/2024

Comparison of Immuno vs. Efficacy Studies

Immuno Studies • Protection dependent on correlate • Sample size in hundreds • Technically easier • Samples collection / storage easier • Consistency easy provided labs have adequate bridging • Always possible provided adequate serology assays exist – 3rd party assays? – Technology transfers to local lab?

Efficacy Studies

• ‘Gold standard’ for vaccine protection

Sample size in thousands

•

Technically difficult

•

Differing samples

•

• Consistency difficult as clinical practice may vary between countries

May not be possible due to

•

– epidemiology factors (e.g. pertussis), – ethical issues (e.g. HIV) or – emergency public health priorities (e.g. pandemic influenza)

• Cheaper and quicker

– Usually primary endpoint involves sample collection ~1 month after last vaccine dose – Longer follow-up possible

• Expensive and takes much longer

– Need to follow-up subjects for an adequate period for sufficient clinical cases to accrue – Event driven analysis may enable expedited results

The Organisation for Professionals in Regulatory Affairs

85

Specific Processes Used by Vaccines to Enable Global Access

EU Medicines for All

The Organisation for Professionals in Regulatory Affairs

86

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