A full video of the event can be found here, and photos here.
The next pandemic will not wait for us to prepare ourselves. Challenge studies (also called controlled human infection models, or CHIMs) can dramatically accelerate the development and testing of a vaccine, drug, or other medical advancements and reveal important details of a pathogen’s biology and the immune response to infection.
Because CHIMs involve deliberately infecting volunteers, they are ethically complex, and deliberations over them can take years. 1Day Sooner partnered with the UK Pandemic Ethics Accelerator and sponsored The Ethics of Controlled Human Infection Model Studies for Mitigating Pandemic Risks, a report that offers a blueprint to shortening that time frame without cutting corners. This aligns with the UK government’s commitment to the 100 Days Mission — to respond to future pandemic threats with effective countermeasures within 100 days.
Dr. Bridget Williams and Professor Dominic Wilkinson discuss the recommendations of the report. Photograph by Photographer London.
Our Pandemic Ethics Accelerator Report Launch (PEARL) event was held in London at the Wellcome Trust on 5 April 2023. The goals were to seek feedback on adopting the presented report recommendations, address the technical and infrastructure bottlenecks in deploying challenge studies during pandemic scenarios, and ascertain the potential contribution of challenge studies to UK biosecurity policy and the 100 Days Mission.
Elisabeth Mahase, editor of BMJ Opinion, moderated a panel by Andy Pollard, Peter Openshaw, Chris Chiu and Shobana Balasingam discussing Covid-19 challenge trials and the report’s recommendations.
The panel before the audience. Photograph by Photographer London.
Professor Chiu, who ran the first Covid-19 challenge studies at Imperial College London, noted that the report accurately described the problems faced in deploying a novel CHIM during a pandemic, including the time to manufacture the challenge agent and the deliberations with ethics committees.
Professor Openshaw remarked that in hindsight, taking the time to establish a challenge model for SARS-CoV-1 after the early 2000s SARS outbreak would have been worthwhile, as we were well aware of how dangerous the coronavirus family is.
Mahase asked if starting the Covid-19 CHIMs earlier would have had a major impact. Professor Chiu and Professor Pollard talked about the rapid course of the pandemic and vaccine development. Humanity was very lucky that many of the initially tested vaccines had such high efficacy, but there was no way of knowing this beforehand — had the first round of major candidates failed, CHIMs would have been useful in selecting other, more promising candidates. Shobana Balasingam, the Research Lead for the Human Infection Study Programme at Wellcome, noted that her program had decided to fund the Covid-19 CHIMs based on this risk of the early vaccines underperforming.
Thus, in Professor Pollard’s view, earlier Covid-19 CHIMs would likely have not made a significant contribution to initial vaccine development, but they were still extremely valuable for their insight into fundamental mechanics of Covid-19 infections. They still be useful for evaluation of future vaccines as well.
The panel further discussed potential acceleration of challenge agent production and related concerns with Good Manufacturing Practice (GMP) standards, as well as recruitment diversity efforts, compensation of volunteers, and the need for dedicated facilities and infrastructure for CHIMs in peacetime.