A UK consortium has announced plans for a ‘One Million Post-Authorisation Study’ to monitor the safety and effectiveness of approved COVID-19 vaccines in real-life conditions. The consortium has been formed by the Drug Safety Research Unit (DSRU) in Southampton, led by Professor Saad Shakir, who will work with a range of scientists across the UK. 

The One Million Post-Authorisation Study will conduct essential monitoring at the ‘post-marketing’ stage to ensure vaccines work and are safe as they should.

One million members of the public who receive a COVID-19 vaccine will be invited to take part. Those who agree will be contacted at set points after the vaccine to check on their health. The study is designed to respond frequently, so that any concerns regarding safety or efficacy can be detected and acted upon quickly. 

According to the team, during the current pandemic, COVID-19 vaccines are going through R&D with unprecedented speed, with development being reduced from 10-12 years to 12-18 months. Therefore, they say it is necessary to conduct post-marketing observational studies to monitor the safety and effectiveness of COVID-19 vaccines and that these studies report in real-time any safety or lack of effectiveness signals so that action can be taken in a timely way. The post-authorisation studies also fill any gaps in knowledge obtained from pre-marketing clinical trials.

Professor Shakir said: “It is well-known that a safe and effective vaccine is vital for protecting the public from COVID-19. The usual development process for a vaccine, including proving its safety and effectiveness, would normally take over a decade, but has been reduced to 12-18 months for COVID-19 vaccines. The methods of the One Million Study benefit from the structure of the National Health Service (NHS) and have been developed to allow near real-time reporting of safety and effectiveness signals, which will be crucial for monitoring newly-licensed COVID-19 vaccines. This is a vital part of ensuring that any vaccine can be safely deployed around the world.”