Major real world safety study on Covid vaccine published

The DSRU has recently published the findings of its major post-authorisation safety study (PASS) on the AstraZeneca Covid vaccine in BMJ Open. This large scale active surveillance study examined the safety and utilisation of the vaccine under real-world use in the UK.

A total of 17945 participants were enrolled on to the study, with eligible participants being followed up at seven timepoints during the first 18 months after receipt of their first dose of the vaccine. At each timepoint, participants were requested to complete an electronic data capture form with information on the safety and utilisation of the vaccine, including details of any adverse events experienced by the participant. All adverse events were assessed by physicians at the DSRU and, for those classified as either serious or an adverse event of special interest (AESI), further information was sought from the participant’s GP.

The study results showed that while the most frequently reported adverse events amongst vaccinees were headache and fatigue, anosmia (loss of smell) and/or ageusia (loss of taste ) were the most frequently reported AESIs. More cases of anaphylaxis were reported than expected, but no safety signals were found during the study.

This study demonstrates the value of the active surveillance methodology in cases where an urgent need for a medicine or vaccine necessitates accelerated approval and only limited premarketing safety data are available.

Read the full publication here: https://bmjopen.bmj.com/content/15/5/e093366.full