The delegates from the national medicines regulatory authorities of 17 countries, who met for the first time to help tackle Covid-19 on 18 March, acknowledged that some vaccine candidates might not need to be tested on animals. This was one of the conclusions from a summary of their meeting, although it should be pointed out that this conclusion was not unanimous.
The report from the International Coalition of Medicines Regulatory Authorities (ICMRA) includes the key findings of discussions between delegates representing more than 20 medicines regulatory authorities from 17 countries globally, co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration. It is structured around two topics: - preclinical data required to begin clinical trials in humans; - the need to address the theoretical risk for vaccine-induced disease enhancement prior to proceeding to first-in-human (FIH) clinical trials.
The way forward
Currently, two candidate vaccines being developed by Moderna and CanSino Biologics have moved into Phase I clinical trials (with healthy volunteers), while a number of other companies and researchers have reported that they are at the pre-clinical development stage.
Preclinical data. The experts stated that the extent of preclinical data required for human testing depended on “the vaccine construct, the supportive data available for the construct and data from closely related products”. They believe that, in general, it is necessary to obtain data in animals and to characterise the immune response induced by the vaccine candidate. But they added that it is not required to demonstrate the efficacy of the vaccine candidate in animal challenge models prior to proceeding to human clinical trials.
Risk of deterioration. Participants acknowledged the urgency of proceeding to FIH trials with the SARS-CoV-2 vaccine candidate in light of the current pandemic but stressed the importance of risk mitigation strategies. They recognised that it was not always possible to test on primates before moving on to humans. The summary notes that, although not unanimous, participants generally agreed that “some vaccine constructs for which there is adequate support from the knowledge around the immune response elicited may be allowed to proceed to FIH clinical trials without first completing animal studies”. To read the report, go to: https://bit.ly/2wzEBrG (Original version in French by Sophie Petitjean)