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Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study.
Lancet Infect Dis. 2021 07; 21(7):939-949.LI

Abstract

BACKGROUND

The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting.

METHODS

In this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI <30 kg/m2vs ≥30 kg/m2), and comorbidities (binary variable, with or without comorbidities).

FINDINGS

Between Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49-68) for ChAdOx1 nCoV-19 and 69% (66-72) for BNT162b2 at 21-44 days and 72% (63-79) for BNT162b2 after 45-59 days.

INTERPRETATION

Systemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days.

FUNDING

ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association.

Authors+Show Affiliations

Department of Twin Research & Genetic Epidemiology, King's College London, London, UK. Electronic address: cristina.menni@kcl.ac.uk.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.ZOE Global, London, UK.ZOE Global, London, UK.ZOE Global, London, UK.Department of Twin Research & Genetic Epidemiology, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK; Medical Research Council Unit for Lifelong Health and Ageing, Department of Population Science and Experimental Medicine, and Centre for Medical Image Computing, Department of Computer Science, University College London, London, UK.Clinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.Clinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.Diabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA; Program in Medical and Population Genetics, Broad Institute, Cambridge, MA, USA.ZOE Global, London, UK.ZOE Global, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.Clinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.Department of Twin Research & Genetic Epidemiology, King's College London, London, UK; National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St Thomas' Foundation Trust, London, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.Department of Infection, Guy's and St Thomas' Foundation Trust, St Thomas Hospital, London, UK.Clinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.ZOE Global, London, UK.Department of Twin Research & Genetic Epidemiology, King's College London, London, UK.Department of Twin Research & Genetic Epidemiology, King's College London, London, UK; Nottingham NIHR Biomedical Research Centre at the School of Medicine, University of Nottingham, Nottingham City Hospital, Nottingham, UK.School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.Department of Twin Research & Genetic Epidemiology, King's College London, London, UK.

Pub Type(s)

Journal Article
Observational Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33930320

Citation

Menni, Cristina, et al. "Vaccine Side-effects and SARS-CoV-2 Infection After Vaccination in Users of the COVID Symptom Study App in the UK: a Prospective Observational Study." The Lancet. Infectious Diseases, vol. 21, no. 7, 2021, pp. 939-949.
Menni C, Klaser K, May A, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939-949.
Menni, C., Klaser, K., May, A., Polidori, L., Capdevila, J., Louca, P., Sudre, C. H., Nguyen, L. H., Drew, D. A., Merino, J., Hu, C., Selvachandran, S., Antonelli, M., Murray, B., Canas, L. S., Molteni, E., Graham, M. S., Modat, M., Joshi, A. D., ... Spector, T. D. (2021). Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. The Lancet. Infectious Diseases, 21(7), 939-949. https://doi.org/10.1016/S1473-3099(21)00224-3
Menni C, et al. Vaccine Side-effects and SARS-CoV-2 Infection After Vaccination in Users of the COVID Symptom Study App in the UK: a Prospective Observational Study. Lancet Infect Dis. 2021;21(7):939-949. PubMed PMID: 33930320.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. AU - Menni,Cristina, AU - Klaser,Kerstin, AU - May,Anna, AU - Polidori,Lorenzo, AU - Capdevila,Joan, AU - Louca,Panayiotis, AU - Sudre,Carole H, AU - Nguyen,Long H, AU - Drew,David A, AU - Merino,Jordi, AU - Hu,Christina, AU - Selvachandran,Somesh, AU - Antonelli,Michela, AU - Murray,Benjamin, AU - Canas,Liane S, AU - Molteni,Erika, AU - Graham,Mark S, AU - Modat,Marc, AU - Joshi,Amit D, AU - Mangino,Massimo, AU - Hammers,Alexander, AU - Goodman,Anna L, AU - Chan,Andrew T, AU - Wolf,Jonathan, AU - Steves,Claire J, AU - Valdes,Ana M, AU - Ourselin,Sebastien, AU - Spector,Tim D, Y1 - 2021/04/27/ PY - 2021/02/18/received PY - 2021/03/26/revised PY - 2021/04/01/accepted PY - 2021/5/1/pubmed PY - 2021/7/2/medline PY - 2021/4/30/entrez SP - 939 EP - 949 JF - The Lancet. Infectious diseases JO - Lancet Infect Dis VL - 21 IS - 7 N2 - BACKGROUND: The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting. METHODS: In this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI <30 kg/m2vs ≥30 kg/m2), and comorbidities (binary variable, with or without comorbidities). FINDINGS: Between Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49-68) for ChAdOx1 nCoV-19 and 69% (66-72) for BNT162b2 at 21-44 days and 72% (63-79) for BNT162b2 after 45-59 days. INTERPRETATION: Systemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days. FUNDING: ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association. SN - 1474-4457 UR - https://www.unboundmedicine.com/medline/citation/33930320/Vaccine_side_effects_and_SARS_CoV_2_infection_after_vaccination_in_users_of_the_COVID_Symptom_Study_app_in_the_UK:_a_prospective_observational_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1473-3099(21)00224-3 DB - PRIME DP - Unbound Medicine ER -