eprintid: 10130527
rev_number: 18
eprint_status: archive
userid: 608
dir: disk0/10/13/05/27
datestamp: 2021-07-02 10:03:01
lastmod: 2021-11-30 23:21:51
status_changed: 2021-07-02 10:03:01
type: article
metadata_visibility: show
creators_name: Menni, C
creators_name: Klaser, K
creators_name: May, A
creators_name: Polidori, L
creators_name: Capdevila, J
creators_name: Louca, P
creators_name: Sudre, CH
creators_name: Nguyen, LH
creators_name: Drew, DA
creators_name: Merino, J
creators_name: Hu, C
creators_name: Selvachandran, S
creators_name: Antonelli, M
creators_name: Murray, B
creators_name: Canas, LS
creators_name: Molteni, E
creators_name: Graham, MS
creators_name: Modat, M
creators_name: Joshi, AD
creators_name: Mangino, M
creators_name: Hammers, A
creators_name: Goodman, AL
creators_name: Chan, AT
creators_name: Wolf, J
creators_name: Steves, CJ
creators_name: Valdes, AM
creators_name: Ourselin, S
creators_name: Spector, TD
title: 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.
ispublished: pub
divisions: UCL
divisions: B02
divisions: D65
divisions: D14
divisions: GA3
divisions: G17
note: © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
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.
date: 2021-07-01
date_type: published
official_url: https://doi.org/10.1016/S1473-3099(21)00224-3
oa_status: green
full_text_type: pub
pmcid: PMC8078878
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1862321
doi: 10.1016/S1473-3099(21)00224-3
pii: S1473-3099(21)00224-3
lyricists_name: Goodman, Anna
lyricists_name: Sudre, Carole
lyricists_id: ALGOO97
lyricists_id: SUDRE45
actors_name: Flynn, Bernadette
actors_id: BFFLY94
actors_role: owner
full_text_status: public
publication: Lancet Infectious Diseases
volume: 21
number: 7
pagerange: 939-949
event_location: United States
citation:        Menni, C;    Klaser, K;    May, A;    Polidori, L;    Capdevila, J;    Louca, P;    Sudre, CH;                                                                                     ... Spector, TD; + view all <#>        Menni, C;  Klaser, K;  May, A;  Polidori, L;  Capdevila, J;  Louca, P;  Sudre, CH;  Nguyen, LH;  Drew, DA;  Merino, J;  Hu, C;  Selvachandran, S;  Antonelli, M;  Murray, B;  Canas, LS;  Molteni, E;  Graham, MS;  Modat, M;  Joshi, AD;  Mangino, M;  Hammers, A;  Goodman, AL;  Chan, AT;  Wolf, J;  Steves, CJ;  Valdes, AM;  Ourselin, S;  Spector, TD;   - view fewer <#>    (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.                   Lancet Infectious Diseases , 21  (7)   pp. 939-949.    10.1016/S1473-3099(21)00224-3 <https://doi.org/10.1016/S1473-3099%2821%2900224-3>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10130527/1/1-s2.0-S1473309921002243-main.pdf