Consortium formed to assess safety of Covid-19 vaccines

A new consortium has been launched to monitor the safety and effectiveness of Covid-19 vaccines after they’ve gone to market.

The Consortium for Monitoring the Safety and Effectiveness of Covid-19 Vaccines has been formed by the Drug Safety Research Unit (DSRU) in Southampton and the Medicines Monitoring Unit (MEMO Research) at the University of Dundee.

The consortium will monitor the safety and effectiveness of Covid-19 vaccines to ensure they are working as they should. Whilst vaccines undergo pre-marketing clinical trials to assess their safety and efficacy, post-marketing observational studies are essential for filling in any gaps in knowledge.

The DSRU and MEMO Research at the University of Dundee previously collaborated to monitor the safety of the new vaccines for swine flu during the 2009 pandemic, and DSRU has 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.”

Members of the public who have received a Covid-19 vaccine will be invited by the consortium to take part in the study. Those taking the vaccine will then be contacted at set points to check on their health.