In preparation for potential approvals of Covid-19 vaccines in the next six to twelve months, the UK's Drug Safety Research Unit (DSRU) and the University of Dundee's Medicines Monitoring Unity (MEMO Research) have set up a new consortium to monitor the safety and effectiveness of Covid-19 vaccines post-approval.
This ensures that the vaccines are working as predicted in clinical trials in the real world. The plan is for people who have received a Covid-19 vaccine to be invited to participate in DSRU and MEMO Research's study for follow-up.
DSRU professor Saad Shakir said: “The usual development process for a vaccine, including proving its safety and effectiveness, would be expected to take as long as 12 to 15 years.
“In order that Covid-19 vaccines can be available as soon as possible, the usual development process will be contracted to a few months.
This means that prior to release, the efficacy of the vaccine will be assessed using biomarkers and limited clinical data.
"Therefore, it is essential to conduct thorough monitoring of the safety and effectiveness of the vaccine at the post-marketing stage.”
University of Dundee professor Isla Mackenzie added: “The members of the consortium have well-honed expertise in conducting post-marketing surveillance of vaccines, following many years’ experience of monitoring the safety of seasonal influenza and swine flu vaccines.
The establishment of this Consortium provides a unique opportunity to conduct the essential post-marketing surveillance in real-world conditions. This is a vital part of ensuring that any vaccine can be safely deployed around the world.”