Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study

Abstract

Background Post-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines. Aim To estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, and report safety profile differences between vaccine brands. Methods We used a self-controlled case series design to estimate relative incidence (RI) of AEIs reported to the national sentinel network, the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub. We compared AEIs (overall and by clinical category) 7 days pre- and post-vaccination to background levels between 1 October 2020 and 12 September 2021. Results Within 7,952,861 records, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs, 4.85% within 7 days post-vaccination. Overall, medically attended AEIs decreased post-vaccination against background levels. There was a 3–7% decrease in incidence within 7 days after both doses of Comirnaty (RI: 0.93; 95% CI: 0.91–0.94 and RI: 0.96; 95% CI: 0.94–0.98, respectively) and Vaxzevria (RI: 0.97; 95% CI: 0.95–0.98). A 20% increase was observed after one dose of Spikevax (RI: 1.20; 95% CI: 1.00–1.44). Fewer AEIs were reported as age increased. Types of AEIs, e.g. increased neurological and psychiatric conditions, varied between brands following two doses of Comirnaty (RI: 1.41; 95% CI: 1.28–1.56) and Vaxzevria (RI: 1.07; 95% CI: 0.97–1.78). Conclusion COVID-19 vaccines are associated with a small decrease in medically attended AEI incidence. Sentinel networks could routinely report common AEI rates, contributing to reporting vaccine safety.

Postpandemic Sentinel Surveillance of Respiratory Diseases in the Context of the World Health Organization Mosaic Framework: Protocol for a Development and Evaluation Study Involving the English Primary Care Network 2023-2024

“…In Domain III ( informing about health interventions ), we are able to infer the impact of interventions, such as lockdowns and shielding, during the COVID-19 pandemic, and we can see from our data the impact of school closures [ 62 , 63 ]. We are strong in measuring vaccine uptake and effectiveness, and our data have been used for vaccine adverse events [ 60 , 64 ]. We only have limited abilities to assess the effectiveness of some antivirals and other therapeutics owing to their central administration, and our capabilities are greater where these are recorded in the GP CMR.…”

Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults

“…Similarly, our data indicated that adverse reactions resulting from heterologous boosting with Ad5-nCoV after three-dose priming with an inactivated SARS-CoV-2 vaccine were predictable and manageable, although they presented with a higher incidence than those induced by homologous boosting with an inactivated vaccine. Tsang et al demonstrated that incidences of adverse reactions decreased with the frequency of vaccination 28 . This may also be a result of the monitoring sensitivity, as adverse reactions were reported in 25.3% of participants that received inactivated SARS-CoV-2 vaccine in our study, a higher percentage than seen in other homologous booster studies 29 .…”

Creating a Modified Version of the Cambridge Multimorbidity Score (CMMS) to Predict Mortality in People Over 16 Years in the English Nationwide General Practice Extraction Service Data for Pandemic Planning and Research (GDPPR) Dataset: Model Development and Validation (Preprint)

“…It has been used for influenza and respiratory disease monitoring for the last 50 years [23]. During the COVID-19 pandemic, with linkage to existing NHS England datasets, RSC data were also used to understand its epidemiology and assess vaccine effectiveness and safety [24][25][26][27]. This modified version of the CMMS was used to assess the real-world effectiveness of the Oxford-AstraZeneca Covid-19 Vaccine in England (RAVEN) study, which was run on the RSC using linked data from NHS England [28].…”