International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines
Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 vaccines to address emerging coronavirus variants. The important role of regulatory alignment is described in the summary of the second workshop on COVID-19 vaccine development and virus variants, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today.
COVID-19 variants have been emerging since March 2020, steadily spreading already before the start of the vaccination campaigns in Europe and abroad. In light of continued mutations and new variants emerging globally, medicines regulators from around the globe have stressed the urgent public health priority to streamline regulatory processes and requirements for the development of new and adaptations of already-approved vaccines to protect against current or future strains.
Workshop participants discussed key regulatory considerations related to the development of second-generation COVID-19 vaccines and booster doses. In particular, they exchanged views on the use of immunobridging (i.e. an approach to infer the likelihood of a vaccine’s protective effect) in the assessment of second-generation COVID-19 vaccines, the design and use of controlled clinical trials (placebo or other controls), and correlates of immunity (i.e. levels of a specific immune marker that indicates optimal protection has been achieved) for vaccines against COVID-19. They also highlighted challenges and issues, such as authorisation of second-generation vaccines and alternative approaches to demonstrate vaccine efficacy, where alignment between regulators is needed to respond to the emerging COVID-19 virus variants.
About the workshop
The virtual workshop took place on 24 June 2021. It built on the experience and knowledge gained from the first workshop on COVID-19 vaccine development and virus variants held in February 2021, which underlined the need for robust data that would help to swiftly approve updated versions of available vaccines against the emerging strains. The second workshop brought together delegates from more than 20 countries, representing 30 medicines regulatory authorities globally and the World Health Organization to exchange information about the global efforts towards developing modified and new vaccines against current and emerging variants.
The meeting was co-chaired by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).