After a virtual meeting global regulators, including the European Medicines Agency, the USA Food and Drug Administration and 18 other agencies, have published a report outlining their consensus data requirements for conducting Phase I clinical studies of coronavirus disease 2019 (COVID-19).
The report consensus is that moving to first-in-human trials quickly is imperative in the face of a global public health crisis, and in some cases, this may justify relaxing normal precautionary requirements such as requiring pre-clinical animal studies, though any risk to human subjects must be thoroughly assessed and mitigated. The report also discusses a “known theoretical risk” that COVID-19 vaccines might, in fact, enhance the disease, and requires developers to address this risk before starting first-in-human studies.
Consistent with these principles, the report recommends allowing first-in-human trials without first conducting animal safety studies for vaccine candidates that are based on well-studied vaccine platforms or similar products that have been shown to be safe. Data demonstrating toxicity and immune response in previous studies will be required. To further mitigate risks, it recommends using healthy young adult volunteers, informing them of any potential risks and monitoring them closely for toxicity and adverse effects after dosing. The report also recommends that animal model toxicity and immune response studies be conducted alongside Phase I studies before larger numbers of patients are dosed in Phase II and Phase III trials.
These recommendations reflect the consensus of the group, though support for them was not unanimous, the report says. They are consistent with several recent and expected regulatory decisions allowing Phase I studies to begin without preclinical studies in animal models.
All participants in the meeting acknowledged the urgency of conducting first-in-human clinical trials with COVID-19 vaccine candidates. The conclusions set out how regulatory authorities around the globe intend to strike the balance between rapid development of vaccines and the need to generate enough robust data to enable decision-making, according to an EMA statement.
Convened by the International Coalition of Medicines Regulatory Authorities with participation of the World Health Organization and the European Commission, the meeting also aimed to encourage exchange of information about the global efforts towards developing new vaccines against COVID-19 through an open dialogue between medicines regulatory authorities around the globe.
Click here for the report text
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