Search

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.

Background: While population estimates suggest high vaccine effectiveness against SARS-CoV-2 infection, the protection for health care workers, who are at higher risk of SARS-CoV-2 exposure, is less understood., Methods: We conducted a national cohort study of health care workers in Wales (UK) from 7 December 2020 to 30 September 2021. We examined uptake of any COVID-19 vaccine, and the effectiveness of BNT162b2 mRNA (Pfizer-BioNTech) against polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection. We used linked and routinely collected national-scale data within the SAIL Databank. Data were available on 82,959 health care workers in Wales, with exposure extending to 26 weeks after second doses., Results: Overall vaccine uptake was high (90%), with most health care workers receiving theBNT162b2 vaccine (79%). Vaccine uptake differed by age, staff role, socioeconomic status; those aged 50-59 and 60+ years old were 1.6 times more likely to get vaccinated than those aged 16-29. Medical and dental staff, and Allied Health Practitioners were 1.5 and 1.1 times more likely to get vaccinated, compared to nursing and midwifery staff. The effectiveness of the BNT162b2 vaccine was found to be strong and consistent across the characteristics considered; 52% three to six weeks after first dose, 86% from two weeks after second dose, though this declined to 53% from 22 weeks after the second dose., Conclusions: With some variation in rate of uptake, those who were vaccinated had a reduced risk of PCR-confirmed SARS-CoV-2 infection, compared to those unvaccinated. Second dose has provided stronger protection for longer than first dose but our study is consistent with waning from seven weeks onwards., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AS is a member of the Scottish Government Chief Medical Officer’s COVID-19 Advisory Group,the New and Emerging Respiratory Virus Threats (NERVTAG) Risk Stratification Subgroupand amember of AstraZeneca’s Thrombotic Thrombocytopenic Task Force; all roles are unremunerated.CR is a member of the Scottish Government Chief Medical Officer’s COVID-19 Advisory Group, the Scientific Pandemic Influenza Group on Modelling and the Medicines & Healthcare products RegulatoryAgency’s Vaccine Benefit and Risk Working Group.DTB is employed by the Public Health Agency, Northern Ireland, and the Department of Health, Northern Ireland.MP is employed by the Vaccine Preventable Disease Programme at Public Health Wales and is involved in the COVID-19 vaccine roll out for Wales.SVK is co-chair of the Scottish Government’s Expert Reference Group on COVID-19 andethnicity, is a member of the Scientific Advisory Group on Emergencies (SAGE) subgroup on ethnicity and acknowledges funding from a NRS Senior Clinical Fellowship, MRC and CSO.RF is a member of is a member of the Scientific Advisory Group on Emergencies (SAGE) Social Care Working Group (SCWG).RO is a member of the National Institute for Health and Care Excellence (NICE) Technology Appraisal Committee (TAC) and has provided methodological advice outside of the submitted work toCogentiaHealthcare Consulting Ltd, F. Hoffmann-La Roche Ltd,the National Institute for Health and Care Excellence (NICE) Decision Support Unit, the University of Bristol, and the Association of the British Pharmaceutical Industry (ABPI).RAL is a member of the Welsh Government COVID19 Technical Advisory Group.All other authors have declared no competinginterests., (Copyright © 2022. Published by Elsevier Ltd.)