Data Requirements for Phase 1 COVID-19 Vaccine Trials

Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making.

Preclinical data required to support proceeding to FIH clinical trials

• The extent of preclinical data to support proceeding to FIH clinical trials depends on the vaccine construct, the supportive data available for the construct and data from closely related products.
• Opportunities to leverage knowledge accumulated with platform technology should be considered to accelerate the development of a SARS-CoV-2 vaccine manufactured using the same platform.
• If a platform technology utilized to manufacture a licensed vaccine or other investigational vaccines is well characterized, it is possible to use toxicology data (e.g., data from repeat dose toxicity studies, biodistribution studies) and clinical data accrued with other products using the same platform to support FIH clinical trials for a SARS-CoV-2 vaccine candidate.
• The vaccine manufacturer should provide a rationale supported by data to justify why certain preclinical studies such as toxicity studies would not need to be conducted prior to proceeding to FIH clinical trials.
• CMC characterization should be adequate to support the safety of the SARS-CoV-2 vaccine construct prior to proceeding to FIH clinical trials.
• For all SARS-CoV-2 vaccine candidates it is necessary to obtain data in animals and to characterize the immune response induced by a SARS-CoV-2 vaccine candidate.
• It is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to FIH clinical trials.

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