Global regulators’ report offers framework for data needed to move COVID-19 vaccines into clinic

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An international report released Tuesday provides a framework for what data COVID-19 vaccine developers should gather before moving into first-in-human studies. The coalition emphasized the need for preclinical data to address the potential of a candidate to worsen the disease.

The recommendations come from a March 18 workshop of the International Coalition of Medicines Regulatory Authorities (ICMRA), which was co-chaired by EMA and FDA.

“The type and extent of preclinical and preliminary clinical data needed to inform the clinical development program for SARS-CoV-2 vaccines must be weighed against the overall risk-benefit assessment of the unmet medical need for vaccines to confront this challenge,” the coalition said.

According to the report, CMC characterization should be adequate to support vaccine safety.

The coalition stated that the amount of preclinical data required to begin first-in-human trials depends on the vaccine construct, the supportive data available for the construct and data from closely related products. If a vaccine is developed using a platform that is well characterized, the company can use toxicology and clinical data from other products.

However, all vaccines should be tested in animal studies to characterize immune response.

The workshop also addressed the risk for vaccine-induced disease enhancement.

“Even though there are limitations in the current knowledge and understanding of risk of enhancement of disease and the value of these models in predicting likelihood of occurrence in humans, studies in animal models are considered important to understand the potential for vaccine induced disease enhancement with SARS-CoV-2 vaccine candidates,” the coalition concluded, though it cautioned that it will not be possible to evaluate every vaccine in non-human primate models.

The totality of available vaccine data should be evaluated with disease worsening in mind, including data on the construct, immune response data, Th1-type skewed immune responses and titers of neutralizing antibodies, as well as the design of the planned first-in-human trial.

Finally, the groups participating in the workshop said there is a need to develop mechanisms to enable sharing of in vivo and clinical data.

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