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Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
,
Mark Joy,
Rachel Byford,
Chris Robertson,
Sneha N Anand,
William Hinton,
Nikhil Mayor ,
Debasish Kar,
John Williams,
William Victor,
Ashley Akbari ,
Declan T Bradley,
Siobhan Murphy,
Dermot O’Reilly,
Rhiannon Owen ,
Antony Chuter,
Jillian Beggs,
Gary Howsam ,
Aziz Sheikh,
FD Richard Hobbs,
Simon de Lusignan
Journal of the Royal Society of Medicine, Volume: 117, Issue: 4, Pages: 134 - 148
Swansea University Authors:
Ashley Akbari , Rhiannon Owen
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DOI (Published version): 10.1177/01410768231205430
Abstract
Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines. Design: We used a self-controlled case se...
| Published in: | Journal of the Royal Society of Medicine |
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| ISSN: | 0141-0768 1758-1095 |
| Published: |
SAGE Publications
2024
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa65099 |
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| Abstract: |
Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines. Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021. Setting: England, UK. Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines. Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance. Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3–7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91–0.94) and 0.96; 95% CI: 0.94–0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95–0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00–1.44)). Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety. |
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| Keywords: |
Epidemiology, public health, vaccination programmes |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
This study was part of the Data and Connectivity National Core Study (DaCVaP, led by Prof Sir Aziz Sheikh at Edinburgh. This was funding created for studies as part of the UK response to the COVID-19 pandemic and funded by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20029, MC_PC_20058). |
| Issue: |
4 |
| Start Page: |
134 |
| End Page: |
148 |