BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland

Igor Rudan; Tristan Millington; Karen Antal; Zoe Grange; Lynda Fenton; Christopher Sullivan; Audrey Buelo; Rachael Wood; Lana Woolford; Olivia V. Swann; Josephine L.K. Murray; Lucy A. Cullen; Emily Moore; Fasih Haider; Fatima Almaghrabi; Jim McMenamin; Utkarsh Agrawal; Syed Ahmar Shah; Steven Kerr; Colin R. Simpson; Srinivasa Vittal Katikireddi; Sir Lewis D. Ritchie; Chris Robertson; Sir Aziz Sheikh

doi:10.1016/j.lanepe.2022.100513

BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland

Igor Rudan, Tristan Millington, Karen Antal, Zoe Grange, Lynda Fenton, Christopher Sullivan, Audrey Buelo, Rachael Wood, Lana Woolford, Olivia V. Swann, Josephine L.K. Murray, Lucy A. Cullen, Emily Moore, Fasih Haider, Fatima Almaghrabi, Jim McMenamin, Utkarsh Agrawal, Syed Ahmar Shah, Steven Kerr, Colin R. SimpsonSrinivasa Vittal Katikireddi, Sir Lewis D. Ritchie, Chris Robertson, Sir Aziz Sheikh^* (Corresponding Author)

^*Corresponding author for this work

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Abstract

Summary Background The two-dose BNT162b2 (Pfizer-BioNTech) vaccine has demonstrated high efficacy against COVID-19 disease in clinical trials of children and young people (CYP). Consequently, we investigated the uptake, safety, effectiveness and waning of the protective effect of the BNT162b2 against symptomatic COVID-19 in CYP aged 12–17 years in Scotland. Methods The analysis of the vaccine uptake was based on information from the Turas Vaccination Management Tool, inclusive of Mar 1, 2022. Vaccine safety was evaluated using national data on hospital admissions and General Practice (GP) consultations, through a self-controlled case series (SCCS) design, investigating 17 health outcomes of interest. Vaccine effectiveness (VE) against symptomatic COVID-19 disease for Delta and Omicron variants was estimated using a test-negative design (TND) and S-gene status in a prospective cohort study using the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) surveillance platform. The waning of the VE following each dose of BNT162b2 was assessed using a matching process followed by conditional logistic regression. Findings Between Aug 6, 2021 and Mar 1, 2022, 75.9% of the 112,609 CYP aged 16–17 years received the first and 49.0% the second COVID-19 vaccine dose. Among 237,681 CYP aged 12–15 years, the uptake was 64.5% and 37.2%, respectively. For 12–17-year-olds, BNT162b2 showed an excellent safety record, with no increase in hospital stays following vaccination for any of the 17 investigated health outcomes. In the 16–17-year-old group, VE against symptomatic COVID-19 during the Delta period was 64.2% (95% confidence interval [CI] 59.2–68.5) at 2–5 weeks after the first dose and 95.6% (77.0–99.1) at 2–5 weeks after the second dose. The respective VEs against symptomatic COVID-19 in the Omicron period were 22.8% (95% CI -6.4–44.0) and 65.5% (95% CI 56.0–73.0). In children aged 12–15 years, VE against symptomatic COVID-19 during the Delta period was 65.4% (95% CI 61.5–68.8) at 2–5 weeks after the first dose, with no observed cases at 2–5 weeks after the second dose. The corresponding VE against symptomatic COVID-19 during the Omicron period were 30.2% (95% CI 18.4–40.3) and 81.2% (95% CI 77.7–84.2). The waning of the protective effect against the symptomatic disease began after five weeks post-first and post-second dose. Interpretation During the study period, uptake of BNT162b2 in Scotland has covered more than two-thirds of CYP aged 12–17 years with the first dose and about 40% with the second dose. We found no increased likelihood of admission to hospital with a range of health outcomes in the period after vaccination. Vaccination with both doses was associated with a substantial reduction in the risk of COVID-19 symptomatic disease during both the Delta and Omicron periods, but this protection began to wane after five weeks. Funding UK Research and Innovation (Medical Research Council); Research and Innovation Industrial Strategy Challenge Fund; Chief Scientist's Office of the Scottish Government; Health Data Research UK; National Core Studies – Data and Connectivity.

Original language	English
Article number	100513
Number of pages	16
Journal	The Lancet Regional Health - Europe
Volume	23
Early online date	28 Sept 2022
DOIs	https://doi.org/10.1016/j.lanepe.2022.100513
Publication status	Published - Dec 2022

Bibliographical note

This study is part of the EAVE II project. EAVE II is funded by the MRC (MC_PC_19075) with the support of BREATHE—The Health Data Research Hub for Respiratory Health (MC_PC_19004), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through the Health Data Research UK. This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). This work was also supported by The Alan Turing Institute via ‘Towards Turing 2.0’ EPSRC Grant Funding. Additional support has been provided through Public Health Scotland, the Scottish Government Director-General Health and Social Care and the University of Edinburgh. The original EAVE project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/46/23). The views expressed are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care, or the UK government. We thank Dave Kelly from Albasoft (Inverness, UK) for his support with making primary care data available, and Wendy Inglis-Humphrey, Vicky Hammersley, and Laura Brook (University of Edinburgh, Edinburgh, UK) for their support with project management and administration.

Data Availability Statement

A data dictionary covering the datasets used in this study can be found at https://github.com/EAVE-II/EAVE-II-data-dictionary. All code used in this study is publicly available at https://github.com/EAVE-II/Covid-Vaccines-CYP. The data used to undertake this analysis are not publicly available because they are based on deidentified national clinical records. These data are available, subject to approval by the NHS Scotland Public Benefit and Privacy Panel, by application through the Scotland National Safe Haven. The data used in this study are sensitive and will not be made publicly available.

Keywords

COVID-19
BNT162b2 COVID-19 vaccination
Vaccine uptake
Vaccine safety
Vaccine effectiveness
Vaccine waning
Children and young people
Age group 12-15 years
Age group 16-17 years
Scotland
United Kingdom
National prospective cohort study

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Rudan, I., Millington, T., Antal, K., Grange, Z., Fenton, L., Sullivan, C., Buelo, A., Wood, R., Woolford, L., Swann, O. V., Murray, J. L. K., Cullen, L. A., Moore, E., Haider, F., Almaghrabi, F., McMenamin, J., Agrawal, U., Shah, S. A., Kerr, S., ... Sheikh, S. A. (2022). BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland. The Lancet Regional Health - Europe, 23, Article 100513. https://doi.org/10.1016/j.lanepe.2022.100513

Rudan, I, Millington, T, Antal, K, Grange, Z, Fenton, L, Sullivan, C, Buelo, A, Wood, R, Woolford, L, Swann, OV, Murray, JLK, Cullen, LA, Moore, E, Haider, F, Almaghrabi, F, McMenamin, J, Agrawal, U, Shah, SA, Kerr, S, Simpson, CR, Katikireddi, SV, Ritchie, SLD, Robertson, C & Sheikh, SA 2022, 'BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland', The Lancet Regional Health - Europe, vol. 23, 100513. https://doi.org/10.1016/j.lanepe.2022.100513

@article{9301cbfcdab94e029547aec0beb79c09,

title = "BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland",

abstract = "Summary Background The two-dose BNT162b2 (Pfizer-BioNTech) vaccine has demonstrated high efficacy against COVID-19 disease in clinical trials of children and young people (CYP). Consequently, we investigated the uptake, safety, effectiveness and waning of the protective effect of the BNT162b2 against symptomatic COVID-19 in CYP aged 12–17 years in Scotland. Methods The analysis of the vaccine uptake was based on information from the Turas Vaccination Management Tool, inclusive of Mar 1, 2022. Vaccine safety was evaluated using national data on hospital admissions and General Practice (GP) consultations, through a self-controlled case series (SCCS) design, investigating 17 health outcomes of interest. Vaccine effectiveness (VE) against symptomatic COVID-19 disease for Delta and Omicron variants was estimated using a test-negative design (TND) and S-gene status in a prospective cohort study using the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) surveillance platform. The waning of the VE following each dose of BNT162b2 was assessed using a matching process followed by conditional logistic regression. Findings Between Aug 6, 2021 and Mar 1, 2022, 75.9% of the 112,609 CYP aged 16–17 years received the first and 49.0% the second COVID-19 vaccine dose. Among 237,681 CYP aged 12–15 years, the uptake was 64.5% and 37.2%, respectively. For 12–17-year-olds, BNT162b2 showed an excellent safety record, with no increase in hospital stays following vaccination for any of the 17 investigated health outcomes. In the 16–17-year-old group, VE against symptomatic COVID-19 during the Delta period was 64.2% (95% confidence interval [CI] 59.2–68.5) at 2–5 weeks after the first dose and 95.6% (77.0–99.1) at 2–5 weeks after the second dose. The respective VEs against symptomatic COVID-19 in the Omicron period were 22.8% (95% CI -6.4–44.0) and 65.5% (95% CI 56.0–73.0). In children aged 12–15 years, VE against symptomatic COVID-19 during the Delta period was 65.4% (95% CI 61.5–68.8) at 2–5 weeks after the first dose, with no observed cases at 2–5 weeks after the second dose. The corresponding VE against symptomatic COVID-19 during the Omicron period were 30.2% (95% CI 18.4–40.3) and 81.2% (95% CI 77.7–84.2). The waning of the protective effect against the symptomatic disease began after five weeks post-first and post-second dose. Interpretation During the study period, uptake of BNT162b2 in Scotland has covered more than two-thirds of CYP aged 12–17 years with the first dose and about 40% with the second dose. We found no increased likelihood of admission to hospital with a range of health outcomes in the period after vaccination. Vaccination with both doses was associated with a substantial reduction in the risk of COVID-19 symptomatic disease during both the Delta and Omicron periods, but this protection began to wane after five weeks. Funding UK Research and Innovation (Medical Research Council); Research and Innovation Industrial Strategy Challenge Fund; Chief Scientist's Office of the Scottish Government; Health Data Research UK; National Core Studies – Data and Connectivity.",

keywords = "COVID-19, BNT162b2 COVID-19 vaccination, Vaccine uptake, Vaccine safety, Vaccine effectiveness, Vaccine waning, Children and young people, Age group 12-15 years, Age group 16-17 years, Scotland, United Kingdom, National prospective cohort study",

author = "Igor Rudan and Tristan Millington and Karen Antal and Zoe Grange and Lynda Fenton and Christopher Sullivan and Audrey Buelo and Rachael Wood and Lana Woolford and Swann, {Olivia V.} and Murray, {Josephine L.K.} and Cullen, {Lucy A.} and Emily Moore and Fasih Haider and Fatima Almaghrabi and Jim McMenamin and Utkarsh Agrawal and Shah, {Syed Ahmar} and Steven Kerr and Simpson, {Colin R.} and Katikireddi, {Srinivasa Vittal} and Ritchie, {Sir Lewis D.} and Chris Robertson and Sheikh, {Sir Aziz}",

note = "This study is part of the EAVE II project. EAVE II is funded by the MRC (MC_PC_19075) with the support of BREATHE—The Health Data Research Hub for Respiratory Health (MC_PC_19004), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through the Health Data Research UK. This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). This work was also supported by The Alan Turing Institute via {\textquoteleft}Towards Turing 2.0{\textquoteright} EPSRC Grant Funding. Additional support has been provided through Public Health Scotland, the Scottish Government Director-General Health and Social Care and the University of Edinburgh. The original EAVE project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/46/23). The views expressed are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care, or the UK government. We thank Dave Kelly from Albasoft (Inverness, UK) for his support with making primary care data available, and Wendy Inglis-Humphrey, Vicky Hammersley, and Laura Brook (University of Edinburgh, Edinburgh, UK) for their support with project management and administration. ",

year = "2022",

month = dec,

doi = "10.1016/j.lanepe.2022.100513",

language = "English",

volume = "23",

journal = "The Lancet Regional Health - Europe",

issn = "2666-7762",

publisher = "Elsevier Ltd",

}

TY - JOUR

T1 - BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland

AU - Rudan, Igor

AU - Millington, Tristan

AU - Antal, Karen

AU - Grange, Zoe

AU - Fenton, Lynda

AU - Sullivan, Christopher

AU - Buelo, Audrey

AU - Wood, Rachael

AU - Woolford, Lana

AU - Swann, Olivia V.

AU - Murray, Josephine L.K.

AU - Cullen, Lucy A.

AU - Moore, Emily

AU - Haider, Fasih

AU - Almaghrabi, Fatima

AU - McMenamin, Jim

AU - Agrawal, Utkarsh

AU - Shah, Syed Ahmar

AU - Kerr, Steven

AU - Simpson, Colin R.

AU - Katikireddi, Srinivasa Vittal

AU - Ritchie, Sir Lewis D.

AU - Robertson, Chris

AU - Sheikh, Sir Aziz

N1 - This study is part of the EAVE II project. EAVE II is funded by the MRC (MC_PC_19075) with the support of BREATHE—The Health Data Research Hub for Respiratory Health (MC_PC_19004), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through the Health Data Research UK. This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). This work was also supported by The Alan Turing Institute via ‘Towards Turing 2.0’ EPSRC Grant Funding. Additional support has been provided through Public Health Scotland, the Scottish Government Director-General Health and Social Care and the University of Edinburgh. The original EAVE project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/46/23). The views expressed are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care, or the UK government. We thank Dave Kelly from Albasoft (Inverness, UK) for his support with making primary care data available, and Wendy Inglis-Humphrey, Vicky Hammersley, and Laura Brook (University of Edinburgh, Edinburgh, UK) for their support with project management and administration.

PY - 2022/12

Y1 - 2022/12

N2 - Summary Background The two-dose BNT162b2 (Pfizer-BioNTech) vaccine has demonstrated high efficacy against COVID-19 disease in clinical trials of children and young people (CYP). Consequently, we investigated the uptake, safety, effectiveness and waning of the protective effect of the BNT162b2 against symptomatic COVID-19 in CYP aged 12–17 years in Scotland. Methods The analysis of the vaccine uptake was based on information from the Turas Vaccination Management Tool, inclusive of Mar 1, 2022. Vaccine safety was evaluated using national data on hospital admissions and General Practice (GP) consultations, through a self-controlled case series (SCCS) design, investigating 17 health outcomes of interest. Vaccine effectiveness (VE) against symptomatic COVID-19 disease for Delta and Omicron variants was estimated using a test-negative design (TND) and S-gene status in a prospective cohort study using the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) surveillance platform. The waning of the VE following each dose of BNT162b2 was assessed using a matching process followed by conditional logistic regression. Findings Between Aug 6, 2021 and Mar 1, 2022, 75.9% of the 112,609 CYP aged 16–17 years received the first and 49.0% the second COVID-19 vaccine dose. Among 237,681 CYP aged 12–15 years, the uptake was 64.5% and 37.2%, respectively. For 12–17-year-olds, BNT162b2 showed an excellent safety record, with no increase in hospital stays following vaccination for any of the 17 investigated health outcomes. In the 16–17-year-old group, VE against symptomatic COVID-19 during the Delta period was 64.2% (95% confidence interval [CI] 59.2–68.5) at 2–5 weeks after the first dose and 95.6% (77.0–99.1) at 2–5 weeks after the second dose. The respective VEs against symptomatic COVID-19 in the Omicron period were 22.8% (95% CI -6.4–44.0) and 65.5% (95% CI 56.0–73.0). In children aged 12–15 years, VE against symptomatic COVID-19 during the Delta period was 65.4% (95% CI 61.5–68.8) at 2–5 weeks after the first dose, with no observed cases at 2–5 weeks after the second dose. The corresponding VE against symptomatic COVID-19 during the Omicron period were 30.2% (95% CI 18.4–40.3) and 81.2% (95% CI 77.7–84.2). The waning of the protective effect against the symptomatic disease began after five weeks post-first and post-second dose. Interpretation During the study period, uptake of BNT162b2 in Scotland has covered more than two-thirds of CYP aged 12–17 years with the first dose and about 40% with the second dose. We found no increased likelihood of admission to hospital with a range of health outcomes in the period after vaccination. Vaccination with both doses was associated with a substantial reduction in the risk of COVID-19 symptomatic disease during both the Delta and Omicron periods, but this protection began to wane after five weeks. Funding UK Research and Innovation (Medical Research Council); Research and Innovation Industrial Strategy Challenge Fund; Chief Scientist's Office of the Scottish Government; Health Data Research UK; National Core Studies – Data and Connectivity.

AB - Summary Background The two-dose BNT162b2 (Pfizer-BioNTech) vaccine has demonstrated high efficacy against COVID-19 disease in clinical trials of children and young people (CYP). Consequently, we investigated the uptake, safety, effectiveness and waning of the protective effect of the BNT162b2 against symptomatic COVID-19 in CYP aged 12–17 years in Scotland. Methods The analysis of the vaccine uptake was based on information from the Turas Vaccination Management Tool, inclusive of Mar 1, 2022. Vaccine safety was evaluated using national data on hospital admissions and General Practice (GP) consultations, through a self-controlled case series (SCCS) design, investigating 17 health outcomes of interest. Vaccine effectiveness (VE) against symptomatic COVID-19 disease for Delta and Omicron variants was estimated using a test-negative design (TND) and S-gene status in a prospective cohort study using the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) surveillance platform. The waning of the VE following each dose of BNT162b2 was assessed using a matching process followed by conditional logistic regression. Findings Between Aug 6, 2021 and Mar 1, 2022, 75.9% of the 112,609 CYP aged 16–17 years received the first and 49.0% the second COVID-19 vaccine dose. Among 237,681 CYP aged 12–15 years, the uptake was 64.5% and 37.2%, respectively. For 12–17-year-olds, BNT162b2 showed an excellent safety record, with no increase in hospital stays following vaccination for any of the 17 investigated health outcomes. In the 16–17-year-old group, VE against symptomatic COVID-19 during the Delta period was 64.2% (95% confidence interval [CI] 59.2–68.5) at 2–5 weeks after the first dose and 95.6% (77.0–99.1) at 2–5 weeks after the second dose. The respective VEs against symptomatic COVID-19 in the Omicron period were 22.8% (95% CI -6.4–44.0) and 65.5% (95% CI 56.0–73.0). In children aged 12–15 years, VE against symptomatic COVID-19 during the Delta period was 65.4% (95% CI 61.5–68.8) at 2–5 weeks after the first dose, with no observed cases at 2–5 weeks after the second dose. The corresponding VE against symptomatic COVID-19 during the Omicron period were 30.2% (95% CI 18.4–40.3) and 81.2% (95% CI 77.7–84.2). The waning of the protective effect against the symptomatic disease began after five weeks post-first and post-second dose. Interpretation During the study period, uptake of BNT162b2 in Scotland has covered more than two-thirds of CYP aged 12–17 years with the first dose and about 40% with the second dose. We found no increased likelihood of admission to hospital with a range of health outcomes in the period after vaccination. Vaccination with both doses was associated with a substantial reduction in the risk of COVID-19 symptomatic disease during both the Delta and Omicron periods, but this protection began to wane after five weeks. Funding UK Research and Innovation (Medical Research Council); Research and Innovation Industrial Strategy Challenge Fund; Chief Scientist's Office of the Scottish Government; Health Data Research UK; National Core Studies – Data and Connectivity.

KW - COVID-19

KW - BNT162b2 COVID-19 vaccination

KW - Vaccine uptake

KW - Vaccine safety

KW - Vaccine effectiveness

KW - Vaccine waning

KW - Children and young people

KW - Age group 12-15 years

KW - Age group 16-17 years

KW - Scotland

KW - United Kingdom

KW - National prospective cohort study

U2 - 10.1016/j.lanepe.2022.100513

DO - 10.1016/j.lanepe.2022.100513

M3 - Article

SN - 2666-7762

VL - 23

JO - The Lancet Regional Health - Europe

JF - The Lancet Regional Health - Europe

M1 - 100513

ER -

BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12–17 years in Scotland

Abstract

Bibliographical note

Data Availability Statement

Keywords

UN SDGs

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