Posted by Michael Wonder on 14 Sep 2021
Access Consortium: alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines
14 September 2021 - Placebo controlled disease outcome trial data are the gold standard for authorising vaccines. However, for COVID-19 vaccines, it is difficult to conduct efficacy trials in some countries, as few candidates are willing and available to participate.
Without established humoral and/or cellular immune parameters that correlate to clinical protection against disease, other approaches are needed to provide sufficient evidence for authorising new COVID-19 vaccines.
The International Coalition of Medicines Regulatory Authorities convened a workshop on 24 June 2021 to consider the development of COVID-19 vaccines.
