BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland

Igor Rudan; Steven Kerr; Christopher Sullivan; Karen Jeffrey; Zoe Grange; Lynda Fenton; Amanj Kurdi; Ting Shi; Lucy A. Cullen; Colin R Simpson; Srinivasa Vittal Katikireddi; Lewis D Ritchie; Chris Robertson; Aziz Sheikh

doi:10.7189/jogh.15.04250

BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland

Igor Rudan^*, Steven Kerr, Christopher Sullivan, Karen Jeffrey, Zoe Grange, Lynda Fenton, Amanj Kurdi, Ting Shi, Lucy A. Cullen, Colin R Simpson, Srinivasa Vittal Katikireddi, Lewis D Ritchie, Chris Robertson, Aziz Sheikh

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Downloads (Pure)

Abstract

Background Few large-scale population studies have examined both safety and vaccine effectiveness (VE) specifically for 5–11-year-olds during the Omicron-dominant period in a setting with low vaccine uptake. The BNT162b2 (Pfizer-BioNTech) vaccine, administered in two doses, has shown strong efficacy against symptomatic and severe COVID-19 in clinical trials involving children and young people (CYP). Accordingly, we examined the uptake, real-world safety, VE, and waning of BNT162b2 VE against symptomatic COVID-19 among children aged 5–11 years in Scotland. Methods This national prospective cohort study used the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform. We evaluated vaccine uptake using national data from the Turas Vaccination Management Tool, up to 16 April 2024. We assessed vaccine safety through national records on hospital admissions, employing a self-controlled case series design to examine 17 predefined health outcomes. We estimated VE against symptomatic, COVID-19 infection confirmed by reverse transcription-polymerase chain reaction and caused by the Omicron variant using a test-negative design. Results From 19 March 2022 to 1 January 2023, 25.3% of the 392 658 children aged 5–11 years received their first COVID-19 vaccine dose and 16.2% completed the second dose. We found no increased risk of safety related hospital admission for 17 health outcomes in the post-vaccination period. During the Omicron period, VE against symptomatic COVID-19 was 60.8% (95% confidence interval (CI) = 0.3–84.5%) at 2–26 weeks post-first dose and 41.6% (95% CI = −89.6, 82.0) at 2–26 weeks post-second dose. The protective effect against symptomatic disease was no longer detectable in the period ≥27 weeks following both the first and second doses. Conclusions The BNT162b2 vaccine demonstrated a strong safety profile in this age group. Receiving both doses was linked to a reduction in the risk of symptomatic COVID-19 during the Omicron variant period, but this protection waned over the following six months.

Original language	English
Article number	04250
Journal	Journal of Global Health
Volume	15
DOIs	https://doi.org/10.7189/jogh.15.04250
Publication status	Published - 29 Aug 2025

Funding

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). SVK acknowledges funding from the Medical Research Council (MC_UU_00022/2) and the Scottish Government Chief Scientist Office (SPHSU17).

UN SDGs

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

SDG 3 Good Health and Well-being

Keywords

vaccine effectiveness
COVID-19
children

Access to Document

10.7189/jogh.15.04250Licence: CC BY 4.0

Rudan-etal-2025-jogh-COVID-19-vaccination-uptake-safety-effectiveness-and-waning-in-childrenFinal published version, 656 KBLicence: CC BY 4.0

Cite this

Rudan, I., Kerr, S., Sullivan, C., Jeffrey, K., Grange, Z., Fenton, L., Kurdi, A., Shi, T., Cullen, L. A., Simpson, C. R., Katikireddi, S. V., Ritchie, L. D., Robertson, C., & Sheikh, A. (2025). BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland. Journal of Global Health, 15, Article 04250. https://doi.org/10.7189/jogh.15.04250

@article{ce0eea1371d94dbe91c803a2cd60dd1c,

title = "BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland",

abstract = "Background Few large-scale population studies have examined both safety and vaccine effectiveness (VE) specifically for 5–11-year-olds during the Omicron-dominant period in a setting with low vaccine uptake. The BNT162b2 (Pfizer-BioNTech) vaccine, administered in two doses, has shown strong efficacy against symptomatic and severe COVID-19 in clinical trials involving children and young people (CYP). Accordingly, we examined the uptake, real-world safety, VE, and waning of BNT162b2 VE against symptomatic COVID-19 among children aged 5–11 years in Scotland. Methods This national prospective cohort study used the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform. We evaluated vaccine uptake using national data from the Turas Vaccination Management Tool, up to 16 April 2024. We assessed vaccine safety through national records on hospital admissions, employing a self-controlled case series design to examine 17 predefined health outcomes. We estimated VE against symptomatic, COVID-19 infection confirmed by reverse transcription-polymerase chain reaction and caused by the Omicron variant using a test-negative design. Results From 19 March 2022 to 1 January 2023, 25.3\% of the 392 658 children aged 5–11 years received their first COVID-19 vaccine dose and 16.2\% completed the second dose. We found no increased risk of safety related hospital admission for 17 health outcomes in the post-vaccination period. During the Omicron period, VE against symptomatic COVID-19 was 60.8\% (95\% confidence interval (CI) = 0.3–84.5\%) at 2–26 weeks post-first dose and 41.6\% (95\% CI = −89.6, 82.0) at 2–26 weeks post-second dose. The protective effect against symptomatic disease was no longer detectable in the period ≥27 weeks following both the first and second doses. Conclusions The BNT162b2 vaccine demonstrated a strong safety profile in this age group. Receiving both doses was linked to a reduction in the risk of symptomatic COVID-19 during the Omicron variant period, but this protection waned over the following six months.",

keywords = "vaccine effectiveness, COVID-19, children",

author = "Igor Rudan and Steven Kerr and Christopher Sullivan and Karen Jeffrey and Zoe Grange and Lynda Fenton and Amanj Kurdi and Ting Shi and Cullen, \{Lucy A.\} and Simpson, \{Colin R\} and Katikireddi, \{Srinivasa Vittal\} and Ritchie, \{Lewis D\} and Chris Robertson and Aziz Sheikh",

year = "2025",

month = aug,

day = "29",

doi = "10.7189/jogh.15.04250",

language = "English",

volume = "15",

}

Rudan, I, Kerr, S, Sullivan, C, Jeffrey, K, Grange, Z, Fenton, L, Kurdi, A, Shi, T, Cullen, LA, Simpson, CR, Katikireddi, SV, Ritchie, LD, Robertson, C & Sheikh, A 2025, 'BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland', Journal of Global Health, vol. 15, 04250. https://doi.org/10.7189/jogh.15.04250

TY - JOUR

T1 - BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland

AU - Rudan, Igor

AU - Kerr, Steven

AU - Sullivan, Christopher

AU - Jeffrey, Karen

AU - Grange, Zoe

AU - Fenton, Lynda

AU - Kurdi, Amanj

AU - Shi, Ting

AU - Cullen, Lucy A.

AU - Simpson, Colin R

AU - Katikireddi, Srinivasa Vittal

AU - Ritchie, Lewis D

AU - Robertson, Chris

AU - Sheikh, Aziz

PY - 2025/8/29

Y1 - 2025/8/29

N2 - Background Few large-scale population studies have examined both safety and vaccine effectiveness (VE) specifically for 5–11-year-olds during the Omicron-dominant period in a setting with low vaccine uptake. The BNT162b2 (Pfizer-BioNTech) vaccine, administered in two doses, has shown strong efficacy against symptomatic and severe COVID-19 in clinical trials involving children and young people (CYP). Accordingly, we examined the uptake, real-world safety, VE, and waning of BNT162b2 VE against symptomatic COVID-19 among children aged 5–11 years in Scotland. Methods This national prospective cohort study used the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform. We evaluated vaccine uptake using national data from the Turas Vaccination Management Tool, up to 16 April 2024. We assessed vaccine safety through national records on hospital admissions, employing a self-controlled case series design to examine 17 predefined health outcomes. We estimated VE against symptomatic, COVID-19 infection confirmed by reverse transcription-polymerase chain reaction and caused by the Omicron variant using a test-negative design. Results From 19 March 2022 to 1 January 2023, 25.3% of the 392 658 children aged 5–11 years received their first COVID-19 vaccine dose and 16.2% completed the second dose. We found no increased risk of safety related hospital admission for 17 health outcomes in the post-vaccination period. During the Omicron period, VE against symptomatic COVID-19 was 60.8% (95% confidence interval (CI) = 0.3–84.5%) at 2–26 weeks post-first dose and 41.6% (95% CI = −89.6, 82.0) at 2–26 weeks post-second dose. The protective effect against symptomatic disease was no longer detectable in the period ≥27 weeks following both the first and second doses. Conclusions The BNT162b2 vaccine demonstrated a strong safety profile in this age group. Receiving both doses was linked to a reduction in the risk of symptomatic COVID-19 during the Omicron variant period, but this protection waned over the following six months.

AB - Background Few large-scale population studies have examined both safety and vaccine effectiveness (VE) specifically for 5–11-year-olds during the Omicron-dominant period in a setting with low vaccine uptake. The BNT162b2 (Pfizer-BioNTech) vaccine, administered in two doses, has shown strong efficacy against symptomatic and severe COVID-19 in clinical trials involving children and young people (CYP). Accordingly, we examined the uptake, real-world safety, VE, and waning of BNT162b2 VE against symptomatic COVID-19 among children aged 5–11 years in Scotland. Methods This national prospective cohort study used the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform. We evaluated vaccine uptake using national data from the Turas Vaccination Management Tool, up to 16 April 2024. We assessed vaccine safety through national records on hospital admissions, employing a self-controlled case series design to examine 17 predefined health outcomes. We estimated VE against symptomatic, COVID-19 infection confirmed by reverse transcription-polymerase chain reaction and caused by the Omicron variant using a test-negative design. Results From 19 March 2022 to 1 January 2023, 25.3% of the 392 658 children aged 5–11 years received their first COVID-19 vaccine dose and 16.2% completed the second dose. We found no increased risk of safety related hospital admission for 17 health outcomes in the post-vaccination period. During the Omicron period, VE against symptomatic COVID-19 was 60.8% (95% confidence interval (CI) = 0.3–84.5%) at 2–26 weeks post-first dose and 41.6% (95% CI = −89.6, 82.0) at 2–26 weeks post-second dose. The protective effect against symptomatic disease was no longer detectable in the period ≥27 weeks following both the first and second doses. Conclusions The BNT162b2 vaccine demonstrated a strong safety profile in this age group. Receiving both doses was linked to a reduction in the risk of symptomatic COVID-19 during the Omicron variant period, but this protection waned over the following six months.

KW - vaccine effectiveness

KW - COVID-19

KW - children

UR - https://www.scopus.com/pages/publications/105014519808

UR - https://github.com/EAVE-II/Covid-Vaccines-CYP

UR - https://github.com/EAVE-II/EAVE-II-data-dictionary

U2 - 10.7189/jogh.15.04250

DO - 10.7189/jogh.15.04250

M3 - Article

AN - SCOPUS:105014519808

SN - 2047-2978

VL - 15

JO - Journal of Global Health

JF - Journal of Global Health

M1 - 04250

ER -

BNT162b2 COVID-19 vaccination uptake, safety, effectiveness, and waning in children and young people aged 5–11 years in Scotland

Abstract

Funding

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Cite this