Japan Publishes COVID-19 Vaccine Trial Principles
In newly released guidelines, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recommends using confirmed SARS-CoV-2 infection, arterial oxygen saturation, requirement of oxygen therapy and death as key study endpoints for clinical trials evaluating COVID-19 vaccines.
The recommendations from the PMDA are similar to those released by the FDA and other regulatory agencies across the world. For the evaluation of COVID-19 vaccine safety, the PMDA advises clinical trial sponsors to collect all adverse events for at least 28 days following vaccine administration.
The PMDA guidelines also asks sponsors to follow trial participants for at least one year to determine long-term safety and efficacy of a COVID-19 vaccine.
The PMDA states in its guideline principles that longer follow-up periods for safety and efficacy assessment may be necessary but will depend on characteristics of the vaccine candidate.
Despite mandating long-term follow-up of these vaccines, the PMDA says it may also allow COVID-19 vaccines to come to market based on preclinical efficacy evidence and immunogenicity data that connect an immunogenic marker to a vaccine’s ability to prevent COVID-19.
The full PMDA principles can be found here: https://bit.ly/345h5AP.