The Drug Safety Research Unit – an independent academic unit based in Southampton, UK – is planning to conduct an active surveillance study on COVID-19 vaccine following regulatory authorisation.
The study will aim to capture the reporting by vaccinees and enable near real-time evaluation and communication of potential side effects.
According to the DSRU, this post-authorisation study will provide the public with reassurance that the vaccines are under continuous monitoring following the rigorous assessment by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
The DSRU is also ‘strongly’ recommending that a series of post-authorisation safety studies are conduct for COVID-19 vaccines to capture the full picture of the effect of the vaccine and also understand the effectiveness of the UK vaccination programme.
In addition to active surveillance studies, this could include spontaneous reporting, in which patients or healthcare professional suspect a side effect and report it without prompting.
In the UK, this is known as the ‘Yellow Card Scheme’, which has been bolstered in preparation for the launch of the new COVID-19 vaccines.
Studies that use secondary data may also be conducted, wherein data sources such as the Clinical Practice Research Datalink (CPRD) and NHS Digital could allow researchers to conduct studies on the safety and effectiveness of COVID-19.
On top of that, exploratory ‘biological studies’ could be used to understand the pathophysiological mechanism and effects of adverse drug reactions.
In these studies, researchers will be required to examine the genotype as well as phenotype changes.
“Post-authorisation safety studies must be fully transparent, report quickly in as near real time as possible and be conducted independently rather than by the vaccine manufacturer,” commented the DSRU.