New consortium will monitor safety/efficacy of COVID-19 vaccines

A new consortium has been established by the Drug Safety Research Unit (DSRU) in Southampton and the Medicines Monitoring Unit (MEMO Research) at the University of Dundee to monitor the safety and effectiveness of COVID-19 vaccines.

The new Consortium for Monitoring the Safety and Effectiveness of COVID-19 Vaccines will allow for monitoring at the ‘post-marketing’ stage, to ensure vaccines work as they should and fill in any gaps from pre-marketing trials.

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.”

“The establishment of this Consortium provides a unique opportunity to conduct the essential post-marketing surveillance in real-world conditions,” added Professor Isla Mackenzie of the University of Dundee. “This is a vital part of ensuring that any vaccine can be safely deployed around the world.”