New UK consortium established to monitor COVID-19 vaccine efficacy once they hit market
The UK’s Drug Safety Research Unit (DSRU) and the University of Dundee’s Medicines Monitoring Unit (MEMO Research) have come together under the shadow of the ongoing pandemic to launch a new consortium to review the safety and efficacy of emerging vaccines to prevent COVID-19 infection.
The newly established Consortium for Monitoring the Safety and Effectiveness of COVID-19 Vaccines will conduct post-marketing studies of vaccine candidates in real time to identify any adverse events associated with lack of safety or efficacy as they occur, meaning action can then be promptly taken.
Monitoring at this stage, especially during a global pandemic, can prove crucial in filling in knowledge gaps around potential vaccine therapies, which unavoidably still remain following clinical testing.
“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,” explained DSRU Director, Professor Saad Shakir. “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.”
This new project isn’t the first time the two organisations have collaborated; they previously worked together in a very similar capacity to assess the safety and efficacy of swine flu vaccines during the 2009 pandemic.
Professor Isla Mackenzie, a Professor of Molecular and Clinical Medicine at the University of Dundee, further explained: “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,” adding: “This is a vital part of ensuring that any vaccine can be safely deployed around the world.”
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