New consortium to monitor safety and effectiveness of COVID-19 vaccines

22 June 2020

A new consortium to monitor the safety and effectiveness of COVID-19 vaccines has been formed by the Drug Safety Research Unit and MEMO Research, University of Dundee.

Developers of vaccines are required to demonstrate quality, safety and efficacy for their products before members of the public start receiving them. Therefore it is necessary to conduct post marketing observational studies to monitor the safety and effectiveness of COVID-19 vaccines to fill any gaps in knowledge obtained from premarketing clinical trials. It is important 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 new consortium for monitoring the safety and effectiveness of COVID-19 vaccines will allow for essential monitoring at the ‘post marketing’ stage to ensure vaccines work as they should. We have previously collaborated with the Medicines Monitoring Unit (MEMO Research) at the University of Dundee to monitor the safety of the new swine flu vaccine during the 2009 pandemic, and we have also conducted enhanced safety surveillance on the seasonal flu vaccine every year since 2014.

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 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.”

Professor Isla Mackenzie of the University of Dundee, said, “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.”

The consortium will invite members of the public who receive a COVID-19 vaccine to take part in the study. Those who agree will be contacted at set points after the vaccine to check on their health. The consortium is soon expected to expand and discussions are already underway with other interested organisations.