lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Effectiveness of BNT162b2 mRNA Vaccine Against Infection and COVID-19 Vaccine Coverage in Healthcare Workers in England, Multicentre Prospective Cohort Study (the SIREN Study)

30 Pages Posted: 22 Feb 2021

See all articles by Victoria Jane Hall

Victoria Jane Hall

Public Health England Colindale; University of Oxford - NIHR Health Protection Research Unit in Healthcare Associated Infection and Antimicrobial Resistance

Sarah Foulkes

Public Health England Colindale

Ayoub Saei

Public Health England Colindale

Nick Andrews

Public Health England Colindale

Blanche Oguti

Public Health England Colindale

Andre Charlett

Public Health England Colindale

Edgar Wellington

Public Health England Colindale

Julia Stowe

Public Health England - Immunisation and Countermeasures Division

Natalie Gillson

Public Health England Colindale

Ana Atti

Public Health England Colindale

Jasmin Islam

Public Health England Colindale

Ioannis Karagiannis

Public Health England Colindale

Katie Munro

Public Health England Colindale

Jameel Khawam

Public Health England Colindale

The SIREN Study Group

Meera A. Chand

Public Health England Colindale

Colin Brown

Public Health England Colindale

Mary E. Ramsay

Public Health England - Immunisation, Hepatitis, and Blood Safety Department

Jamie Lopez Bernal

Public Health England Colindale

Susan Hopkins

University of Oxford - NIHR Health Protection Research Unit in Healthcare Associated Infection and Antimicrobial Resistance; Public Health England Colindale

More...

Abstract

Background: BNT162b2 mRNA and ChAdOx1 nCOV-19 adenoviral vector vaccines have been rapidly rolled out in the UK. We determined the factors associated with vaccine coverage for both vaccines and documented the vaccine effectiveness of the BNT162b2 mRNA vaccine in our healthcare worker (HCW) cohort study of staff undergoing regular asymptomatic testing.

Methods: The SIREN study is a prospective cohort study among staff working in publicly funded hospitals. Baseline risk factors, vaccination status (from 8/12/2020-5/2/2021), and symptoms are recorded at 2 weekly intervals and all SARS-CoV-2 polymerase chain reaction (PCR) and antibody test results documented. A mixed effect proportional hazards frailty model using a Poisson distribution was used to calculate hazard ratios to compare time to infection in unvaccinated and vaccinated participants to estimate the impact of the BNT162b2 vaccine on all (asymptomatic and symptomatic) infection.

Findings: Vaccine coverage was 89% on 5/2/2021. Significantly lower coverage was associated with prior infection (aOR 0.59 95% confidence interval [CI] 0.54-0.64), female (aOR 0.72, 95% CI 0.63-0.82), aged under 35 years, being from minority ethnic groups (especially Black, aOR 0.26, 95% CI 0.21-0.32), porters/security guards (aOR 0.61, 95% CI 0.42-0.90),or midwife (aOR 0.74, 95% CI 0.57-0.97), and living in more deprived neighbourhoods (IMD 1 (most) vs. 5 (least) (aOR 0.75, 95% CI 0.65-0.87). A single dose of BNT162b2 vaccine demonstrated vaccine effectiveness of 72% (95% CI 58-86) 21 days after first dose and 86% (95% CI 76-97) seven days after two doses in the antibody negative cohort.

Conclusion: Our study demonstrates that the BNT162b2 vaccine effectively prevents both symptomatic and asymptomatic infection in working age adults; this cohort was vaccinated when the dominant variant in circulation was B1.1.7 and demonstrates effectiveness against this variant.

Trial Registration: IRAS ID 284460, REC reference 20/SC/0230 Berkshire Research Ethics Committee, Health Research Authority and Health and Care Research Wales approval granted 22 May 2020. Trial registered with ISRCTN, Trial ID: ISRCTN11041050. https://www.isrctn.com/ISRCTN11041050

Funding: The study is funded by the United Kingdom’s Department of Health and Social Care and Public Health England, with contributions from the Scottish, Welsh and Northern Irish governments. Funding is also provided by the National Institute for Health Research (NIHR) as an Urgent Public Health Priority Study (UPHP). SH, VH are supported by the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford in partnership with Public Health England (PHE) (NIHR200915). AC is supported by NIHR HealthProtection Research Unit in Behavioural Science and Evaluation at University of Bristol in partnership with Public Health England. MR, NA, AC are supported by NIHR HealthProtection Research Unit in Immunisation at the London School of Hygiene and Tropical Medicine in partnership with Public Health England.

Conflict of Interest: The Immunisation and Countermeasures Division has provided vaccine manufacturers(including Pfizer) with post-marketing surveillance reports on pneumococcal andmeningococcal infection which the companies are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. A cost recovery charge is made for these reports.

Ethical Approval: The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12/1/2021.

Suggested Citation

Hall, Victoria Jane and Foulkes, Sarah and Saei, Ayoub and Andrews, Nick and Oguti, Blanche and Charlett, Andre and Wellington, Edgar and Stowe, Julia and Gillson, Natalie and Atti, Ana and Islam, Jasmin and Karagiannis, Ioannis and Munro, Katie and Khawam, Jameel and Group, The SIREN Study and Chand, Meera A. and Brown, Colin and Ramsay, Mary E. and Bernal, Jamie Lopez and Hopkins, Susan, Effectiveness of BNT162b2 mRNA Vaccine Against Infection and COVID-19 Vaccine Coverage in Healthcare Workers in England, Multicentre Prospective Cohort Study (the SIREN Study). Available at SSRN: https://ssrn.com/abstract=3790399 or http://dx.doi.org/10.2139/ssrn.3790399

Victoria Jane Hall (Contact Author)

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

University of Oxford - NIHR Health Protection Research Unit in Healthcare Associated Infection and Antimicrobial Resistance

Oxford
United Kingdom

Sarah Foulkes

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Ayoub Saei

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Nick Andrews

Public Health England Colindale ( email )

Wellington House
133-155 Waterloo Road
London, SE1 8UG
United Kingdom

Blanche Oguti

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Andre Charlett

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Edgar Wellington

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Julia Stowe

Public Health England - Immunisation and Countermeasures Division ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Natalie Gillson

Public Health England Colindale

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Ana Atti

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Jasmin Islam

Public Health England Colindale

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Ioannis Karagiannis

Public Health England Colindale

Katie Munro

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Jameel Khawam

Public Health England Colindale

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Meera A. Chand

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Colin Brown

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

Mary E. Ramsay

Public Health England - Immunisation, Hepatitis, and Blood Safety Department ( email )

United Kingdom

Jamie Lopez Bernal

Public Health England Colindale ( email )

Wellington House
133-155 Waterloo Road
London, SE1 8UG
United Kingdom

Susan Hopkins

University of Oxford - NIHR Health Protection Research Unit in Healthcare Associated Infection and Antimicrobial Resistance ( email )

Oxford
United Kingdom

Public Health England Colindale ( email )

61 Colindale Avenue
London, NW9 5EQ
United Kingdom

No contact information is available for The SIREN Study Group

Click here to go to TheLancet.com

Paper statistics

Abstract Views
115,837
Downloads
17,293
PlumX Metrics