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. 2022 Sep 28:23:100513.
doi: 10.1016/j.lanepe.2022.100513. eCollection 2022 Dec.

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

Igor Rudan  1 , Tristan Millington  1 , Karen Antal  2 , Zoe Grange  2 , Lynda Fenton  2 , Christopher Sullivan  2 , Audrey Buelo  2 , Rachael Wood  1   2 , Lana Woolford  1 , Olivia V Swann  3   4 , Josephine L K Murray  2 , Lucy A Cullen  2 , Emily Moore  2 , Fasih Haider  1 , Fatima Almaghrabi  1 , Jim McMenamin  2 , Utkarsh Agrawal  5 , Syed Ahmar Shah  1 , Steven Kerr  1 , Colin R Simpson  6 , Srinivasa Vittal Katikireddi  7 , Sir Lewis D Ritchie  8 , Chris Robertson  2   9 , Sir Aziz Sheikh  1
Affiliations

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

Igor Rudan et al. Lancet Reg Health Eur. .

Abstract

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

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Conflict of interest statement

A.S., C.R. and J.McM. are members of the Scottish Government Chief Medical Officer's COVID-19 Advisory Group and A.S. of its Standing Committee on Pandemics. A.S. & J.McM. are also members of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) Risk Stratification Subgroup. J.McM. is the Chair of the multidisciplinary Scottish COVID-19 National Incident Management Team. A.S. is a member of AstraZeneca's Thrombotic Thrombocytopenic Taskforce. SVK is a member of the U.K. Government's Scientific Advisory Group on Emergencies subgroup on ethnicity, the Cabinet Office's International Best Practice Advisory Group and was co-chair of the Scottish Government's Expert Reference Group on Ethnicity and COVID-19. C.R. reports grants from the MRC and Public Health Scotland, during the conduct of the study, and is a member of the Scientific Pandemic Influenza Group on Modelling, Medicines and Healthcare products Regulatory Agency, Vaccine Benefit and Risk Working Group. I.R. is a member of the Scientific Council on COVID-19 of the Republic of Croatia and co-Editor-in-Chief of the Journal of Global Health. All roles have been unremunerated. All other authors report no potential competing interest.

Figures

Figure 1:
Figure 1
Visualisation of the uptake of BNT162b2 vaccine among 16-17 (left graph) and 12-15 (right graph) year-olds in Scotland: blue lines represent first dose uptake, red lines second dose uptake. Status at a date Mar 1, 2022.
Figure 2
Figure 2
a-d: (a) top left: vaccine effectiveness (VE) of the BNT162b2 vaccine in 16-17 year olds, expressed as risk ratios (Y-axis) and weeks after each dose (X-axis), for the Delta variant; (b) top right: vaccine effectiveness for the BNT162b2 vaccine in 16-17 year olds, for the Omicron variant; (c) bottom left: vaccine effectiveness for the BNT162b2 vaccine in 12-15 year olds, for the Delta variant; (d) bottom right: vaccine effectiveness (VE) of the BNT162b2 vaccine in 12-15 year olds, for the Omicron variant. Odds ratios were estimated using a conditional logistic regression model, with positive tests matched to negative controls by age, location, and date of test. The model contains adjustments for sex, deprivation, urban/rural classification, previous positivity, number of previous tests and risk group category.
Figure 2
Figure 2
a-d: (a) top left: vaccine effectiveness (VE) of the BNT162b2 vaccine in 16-17 year olds, expressed as risk ratios (Y-axis) and weeks after each dose (X-axis), for the Delta variant; (b) top right: vaccine effectiveness for the BNT162b2 vaccine in 16-17 year olds, for the Omicron variant; (c) bottom left: vaccine effectiveness for the BNT162b2 vaccine in 12-15 year olds, for the Delta variant; (d) bottom right: vaccine effectiveness (VE) of the BNT162b2 vaccine in 12-15 year olds, for the Omicron variant. Odds ratios were estimated using a conditional logistic regression model, with positive tests matched to negative controls by age, location, and date of test. The model contains adjustments for sex, deprivation, urban/rural classification, previous positivity, number of previous tests and risk group category.
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