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Vaccine after Effects and Post-Vaccine Infection in a Real World Setting: Results from the COVID Symptom Study App

26 Pages Posted: 4 Mar 2021

See all articles by Cristina Menni

Cristina Menni

King's College London - Department of Twin Research and Genetic Epidemiology

Kerstin Klaser

King’s College London - School of Biomedical Engineering & Imaging Sciences

Anna May

Zoe Global Limited

Lorenzo Polidori

Zoe Global Limited

Joan Capdevila

Zoe Global Limited

Panayiotis Louca

King’s College London - Department of Twin Research and Genetic Epidemiology

Carole Sudre-Ferraris

University College London

Long H. Nguyen

Harvard University - Harvard Medical School

David A. Drew

Harvard University - Harvard Medical School

Jordi Merino

Massachusetts General Hospital - Center for Genomic Medicine

Michela Antonelli

King’s College London - School of Biomedical Engineering & Imaging Sciences

Benjamin Murray

King’s College London

Liane S. Canas

King’s College London - School of Biomedical Engineering & Imaging Sciences

Erika Molteni

King’s College London - School of Biomedical Engineering & Imaging Sciences

Mark S. Graham

King’s College London - School of Biomedical Engineering & Imaging Sciences

Marc Modat

King’s College London - School of Biomedical Engineering & Imaging Sciences

Amit D. Joshi

Harvard University - Harvard Medical School

Massimo Mangino

King’s College London - Department of Twin Research and Genetic Epidemiology

Alexander Hammers

King’s College London - Division of Biomedical Engineering and Imaging Sciences

Tim D. Spector

King’s College London - Department of Twin Research and Genetic Epidemiology

Ana M. Valdes

University of Nottingham

Anna L. Goodman

University College London - Department of Infection

Andrew T. Chan

Harvard University - Harvard Medical School

Jonathan Wolf

Zoe Global Limited

Claire J. Steves

King’s College London - Department of Twin Research and Genetic Epidemiology

Sebastien Ourselin

King’s College London - School of Biomedical Engineering & Imaging Sciences

Tim D. Spector

King's College London - Department of Twin Research and Genetic Epidemiology; St. Thomas' Hospital, London

More...

Abstract

Background:  The Pfizer-BioNTech (BNT162b2) and the Oxford/AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in Phase III trials. Here we report results from a real world setting on the two most administered vaccines in the UK.

Methods: We investigated self-reported systemic and local effects within eight days of vaccination in 387,471 individuals from the COVID Symptom Study app who received one (n=209,251) or two (n=13,478) doses of the BNT162b2 vaccine, or one dose of  ChAdOx1 nCoV-19 vaccine (n=178,220) between December 8 and February 15 2021. A subset of individuals subsequently tested for SARS-CoV-2 were studied for infection rates from PCR or lateral flow test results post-vaccination (59,639 vaccinated vs 277,599 controls).

Findings: Systemic side effects were reported in 11.8% of participants after the first BNT162b2 dose, 20.3% after the second BNT162b2 dose, and 29.4% after the first ChAdOx1 nCoV-19 dose. Systemic effects were more prevalent among individuals with pre-existing COVID-19 infection (BNT162b2:34.1%; ChAdOx1 nCoV-19:51.6%) than among individuals without known prior infection (BNT162b2:10.6%; ChAdOx1 nCoV-19:28.6%) and among those aged <55 years (BNT162b2:19.9%; ChAdOx1 nCoV-19:45.3%) compared to those aged >55 years (BNT162b2:9.2%, ChAdOx1 nCoV-19: 26.9%). We observed significant reduction in infection risk 12-21 days after the first dose (BNT162b2:-57% [-71%, -38%], ChAdOx1 nCoV-19:-42% [-71%, -17%]). 

Interpretation: This phase IV-type study assessing both BNT162b2 and ChAdOx1 nCoV-19 vaccines identifies mild systemic side effects affecting 11-30% of individuals post-vaccination, lower than in published Phase III trials. Our data on infection post-vaccine were also reassuring.

Funding: Zoe, NIHR, CDRF, NIH, MRC

Declaration of Interests: TDS and AMV are consultants to Zoe Global Ltd (“Zoe”). JW, AM, LP and JC are employees of Zoe Global Limited. ALG is a regional PI on the COV002 trial and the Novavax COVID-19 vaccine trial and as such her organisation has received grants from Novavax. Other authors have no conflict of interest to declare.

Ethics Approval Statement: Ethical approval for use of the app for research purposes in the UK was obtained from King’s College London Ethics Committee (review reference LRS-19/20-18210), and all users provided consent for non-commercial use.

Keywords: COVID-19; vaccination; Phase IV trial; Pfizer-BioNTech; Oxford/AstraZeneca; BNT162b2; ChAdOx1 nCoV-19

Suggested Citation

Menni, Cristina and Klaser, Kerstin and May, Anna and Polidori, Lorenzo and Capdevila, Joan and Louca, Panayiotis and Sudre-Ferraris, Carole and Nguyen, Long H. and Drew, David A. and Merino, Jordi and Antonelli, Michela and Murray, Benjamin and Canas, Liane S. and Molteni, Erika and Graham, Mark S. and Modat, Marc and Joshi, Amit D. and Mangino, Massimo and Hammers, Alexander and Spector, Tim D. and Valdes, Ana M. and Goodman, Anna L. and Chan, Andrew T. and Wolf, Jonathan and Steves, Claire J. and Ourselin, Sebastien and Spector, Tim D., Vaccine after Effects and Post-Vaccine Infection in a Real World Setting: Results from the COVID Symptom Study App. Available at SSRN: https://ssrn.com/abstract=3795344 or http://dx.doi.org/10.2139/ssrn.3795344

Cristina Menni (Contact Author)

King's College London - Department of Twin Research and Genetic Epidemiology ( email )

Strand
London, England WC2R 2LS
United Kingdom

Kerstin Klaser

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Anna May

Zoe Global Limited ( email )

Lorenzo Polidori

Zoe Global Limited ( email )

Joan Capdevila

Zoe Global Limited ( email )

Panayiotis Louca

King’s College London - Department of Twin Research and Genetic Epidemiology ( email )

London
United Kingdom

Carole Sudre-Ferraris

University College London

Long H. Nguyen

Harvard University - Harvard Medical School

25 Shattuck St
Boston, MA 02115
United States

David A. Drew

Harvard University - Harvard Medical School

25 Shattuck St
Boston, MA 02115
United States

Jordi Merino

Massachusetts General Hospital - Center for Genomic Medicine ( email )

185 Cambridge Street
Boston, MA 02114
United States

Michela Antonelli

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Benjamin Murray

King’s College London ( email )

Strand
London, England WC2R 2LS
United Kingdom

Liane S. Canas

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Erika Molteni

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Mark S. Graham

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Marc Modat

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Amit D. Joshi

Harvard University - Harvard Medical School

25 Shattuck St
Boston, MA 02115
United States

Massimo Mangino

King’s College London - Department of Twin Research and Genetic Epidemiology

London
United Kingdom

Alexander Hammers

King’s College London - Division of Biomedical Engineering and Imaging Sciences ( email )

London
United Kingdom

Tim D. Spector

King’s College London - Department of Twin Research and Genetic Epidemiology ( email )

London
United Kingdom

Ana M. Valdes

University of Nottingham

University Park
Nottingham, NG8 1BB
United Kingdom

Anna L. Goodman

University College London - Department of Infection ( email )

Gower Street
London, WC1E 6BT
United Kingdom

Andrew T. Chan

Harvard University - Harvard Medical School

25 Shattuck St
Boston, MA 02115
United States

Jonathan Wolf

Zoe Global Limited ( email )

Claire J. Steves

King’s College London - Department of Twin Research and Genetic Epidemiology ( email )

United Kingdom

Sebastien Ourselin

King’s College London - School of Biomedical Engineering & Imaging Sciences ( email )

Strand
London, WC2R 2LS
United Kingdom

Tim D. Spector

King's College London - Department of Twin Research and Genetic Epidemiology

Strand
London, England WC2R 2LS
United Kingdom

St. Thomas' Hospital, London ( email )

Lambeth Palace Road
London, SE1 7EH
United Kingdom