Paper published: Can post-marketing studies provide a safety net for COVID-19 vaccines in the UK?
22 October 2020
Our new paper published in BMJ Evidence Based Medicine explains that, given the speed with which potential new COVID-19 vaccines are being developed, it is more important than ever to monitor the safety of the vaccines even after they are licensed for use in the general public
Since the start of the COVID-19 pandemic, the world has never been more interested in vaccine development. Researchers across the globe are racing to develop an effective yet safe vaccine to protect populations from the new virus and there is hope that thanks to the extraordinary efforts of scientists, at least one vaccine will be ready for use in coming months. However recent cases of illness or death amongst volunteers involved in clinical trials of the new COVID-19 vaccines have highlighted that the path to develop new vaccines and medicines is rarely a smooth one.
Development of a new vaccine would normally take about 10 – 12 years, but in the current global public health crisis, the development of a COVID-19 vaccine may be achieved in only 12 – 18 months. The COVID-19 vaccines will be fast tracked through the usual pre-licensing requirements and will be introduced to the population with limited clinical trial data. In this scenario, surveillance of the vaccine in the real world becomes even more paramount. Post-authorisation observational studies form an essential safety net by continuing to monitor the effectiveness and safety of a COVID-19 vaccine after it is licensed for use. Such studies are complementary to prelaunch clinical trials and not a replacement.