Post-market study to monitor safety and effectiveness of Covid-19 vaccines

Plans have been made to launch a Covid-19 study which monitors the safety and effectiveness of a vaccine in real-life conditions, once one has been launched.

The ‘One Million’ Post-Authorisation Study has been formed by the Drug Safety Research Unit (DSRU) in Southampton. They study aims to ensure vaccines are safe and working as they should be once they have made it to market.  

A consortium of academia and healthcare professionals will lead the study, utilising their experience in active surveillance of vaccines. During the 2009 swine flu pandemic, the DSRU conducted safety monitoring for the H1N vaccine, and has also conducted safety surveillance on a seasonal flu vaccine every year since 2014.

The consortium will invite one million members of the public who receive a Covid-19 vaccine to take part in the study. Participants will be contacted at set points after the vaccine to check on their health. The study is being designed so that any concerns regarding safety or efficacy can be acted upon quickly.

Vaccine makers need to demonstrate quality, safety and efficacy for their products before they can used by members of the public. Since Covid-19 vaccines are being produced at a much faster pace than usual, it is necessary to conduct post-marketing observational studies to monitor the safety and effectiveness of these vaccines in case any action needs to be taken. Post-marketing studies also give developers a more detailed idea of how the products work and fill in any gaps in knowledge obtained from clinical trials before launch.

Professor Saad Shakir, of the DSRU, 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 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.”