Interview and article by Christine Clark.
The Vac4covid study has been designed to provide important data about the safety and effectiveness of covid-19 vaccines. IMI interviewed Mr Gavin Dobson, the Clinical Trials Pharmacist for MEMO Research at the University of Dundee to find out more.
As concerns about possible vaccine side effects have prompted measures to restrict usage in some countries, the need for robust epidemiological data to determine the true frequency of adverse effects has never been greater. Mr Dobson is the Superintendent Pharmacist of MEMO Clinical Trials Pharmacy and also Communications Lead for social media and email support. He has been closely involved with the development and operation of the Vac4covid study.
“Vac4covid is a prospective, active observational, post-authorisation cohort safety study (PASS) of vaccines for COVID-19 disease. In lay terms, it is a UK-wide, online study to monitor all UK-approved COVID-19 vaccines in real-time and to provide data to the MHRA”, explains Mr Dobson.
Vaccines have undergone thorough testing for safety and efficacy but, like any new medicine, they are intensively monitored for the first few months or years of use to identify rare adverse events. This is done through the Black Triangle Scheme in which product literature is marked with an inverted black triangle (▼) to indicate the requirement for additional reporting. The Medicines and Healthcare products Regulatory Agency (MHRA) asks that all suspected reactions (including those considered not to be serious) are reported through the Yellow Card Scheme.
“While Vac4covid does not take the place of either of these schemes, our near real-time reporting may be advantageous to the MHRA”, says Mr Dobson.
The study is using the nationally-recognised Brighton Collaboration list of potential Adverse Events of Special Interest (AESIs) as a starting point. “But we will also review our own data for any participant reported events occurring at a higher frequency than expected. We will expand our list of potential AESIs as requested by the MHRA, and if other potential AESI flags are raised elsewhere”, adds Mr Dobson.
Find more on vac4covid here