Online surveys key to safety data for novel vaccines concludes report
29 May 2023
Online surveys provide an efficient means to gather drug safety data on novel vaccines rolled out at scale, says a new European study that assessed the performance of Covid-19 programmes.
Nearly 118,000 participants in seven European countries including the UK, completed questionnaires for at least six months following their first dose of COVID-19 vaccines, with data made available to researchers close to real time, allowing rates of adverse reactions to be regularly updated.
Led by Monika Raethke of Lareb, the Netherlands Pharmacovigilance Centre, with the Drug Safety Research Unit leading the UK arm of the survey, the study was published in Drug Safety journal.
Director of the Drug Safety Research Unit Professor Saad Shakir, said, the introduction of a monitoring system in multiple countries for rapid data collection, was desperately needed when the first Covid vaccines were released.
“We have shown that online reporting is a feasible way of collecting data from people in real life conditions. These patient reported outcomes are important because they include information on adverse reactions that would not be found in medical records as patients who experience short-term, non-serious reactions would not typically consult a healthcare professional,” he explained.
“This approach is well suited to monitoring safety of vaccines at the start of roll-out when large databases suitable for retrospective safety studies are not yet available.”
More than three quarters (75.9%), of the respondents of the respondents received the AstraZeneca vaccine, followed by BioNTech/Pfizer (12.4%), Moderna (9.6%), and Janssen (2.1%).
Fatigue, headache and injection-site pain were the most commonly reported adverse reactions. The published study stated that rates of 'adverse events of special interest' (AESIs) were 0.1–0.2% across all vaccine brands, concluding that serious reactions or AESIs were uncommon, consistent with details on product labels.
Funding sources included the European Medicines Agency (EMA), with data collection in some countries funded by governments. Final results and analysis from the study will be published later.