Regulators from the United Kingdom and Japan are promoting the use of platform trials to evaluate second-generation COVID-19 vaccines as the pool of unvaccinated patients for testing new vaccines grows increasingly smaller. They also proposed the creation of a working group to build consensus on the design of master protocols, particularly in the context of health emergencies.
These pronouncements emerged from a 24 June virtual workshop on aligning approaches for developing second-generation COVID-19 vaccines and boosters sponsored by the International Council of Medicines Regulatory Authorities (ICMRA). The workshop was attended by delegates from over 20 countries and delegates from the World Health Organization.
At the workshop, regulators from the Japanese Medical Devices Agency (PMDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) proposed increased use of “platform” study designs, or using several investigational drugs with a single active comparator to evaluate vaccine efficacy, as a “suitable” alternative to conventional clinical trials for COVID-19 vaccines.