tetano
Editor, Senior Moderator
J Glob Health
. 2021 Dec 25;11:05026.
doi: 10.7189/jogh.11.05026. eCollection 2021.
Uptake, effectiveness and safety of COVID-19 vaccines in children and young people in Scotland: Protocol for early pandemic evaluation and enhanced surveillance of COVID-19 (EAVE II)
Davies Adeloye[SUP] 1 [/SUP], Srinivasa Vittal Katikireddi[SUP] 2 [/SUP], Lana Woolford[SUP] 1 [/SUP], Colin R Simpson[SUP] 1 3 [/SUP], Syed Ahmar Shah[SUP] 1 [/SUP], Utkarsh Agrawal[SUP] 4 [/SUP], Lewis D Richie[SUP] 5 [/SUP], Olivia V Swann[SUP] 6 [/SUP], Sarah J Stock[SUP] 1 [/SUP], Chris Robertson[SUP] 7 8 [/SUP], Aziz Sheikh[SUP] 1 [/SUP], Igor Rudan[SUP] 1 [/SUP]
Affiliations
Abstract
Background: The dynamics of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission and severity of disease among children and young people (CYP) across different settings are of considerable clinical, public health and societal interest. Severe COVID-19 cases, requiring hospitalisations, and deaths have been reported in some CYP suggesting a need to extend vaccinations to these age groups. As part of the ongoing Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) study, we aim to investigate the uptake, effectiveness and safety of COVID-19 vaccines in children and young people (CYP) aged 0 to 17 years in Scotland. Specifically, we will estimate: (i) uptake of vaccines against COVID-19, (ii) vaccine effectiveness (VE) against the outcomes of symptomatic SARS-CoV-2 infection, hospitalisation, intensive care unit (ICU) admissions, and death; (iii) VE for first/second dose timing among different age groups and risk groups; and (iv) the safety of vaccines.
Methods and analysis: We will conduct an open prospective cohort study classifying exposure as time-varying. We will compare outcomes amongst first dose vaccinated and second dose vaccinated CYP to those not yet vaccinated. A Test Negative Design (TND) case control study will be nested within this national cohort to investigate VE against symptomatic infection. The primary outcomes will be (i) uptake of vaccines against COVID-19, (ii) time to COVID-19 infection, hospitalisation, ICU admissions or death, and (iii) adverse events related to vaccines. Vaccination status (unvaccinated, one dose and two doses) will be defined as a time-varying exposure. Data from multiple sources will be linked using a unique identifier. We will conduct descriptive analyses to explore trends in vaccine uptake, and association between different exposure variables and vaccine uptake will be determined using multivariable logistic regression models. VE will be assessed from time-dependent Cox models or Poisson regression models, adjusted for relevant confounders, including age, sex, socioeconomic status, and comorbidities. We will employ self-controlled study designs to determine the risk of adverse events following COVID-19 vaccination.
Ethics and dissemination: Ethics approval was obtained from the National Research Ethics Committee, South East Scotland 02. We will present findings of this study at international conferences, in peer-reviewed journals and to policy-makers.
. 2021 Dec 25;11:05026.
doi: 10.7189/jogh.11.05026. eCollection 2021.
Uptake, effectiveness and safety of COVID-19 vaccines in children and young people in Scotland: Protocol for early pandemic evaluation and enhanced surveillance of COVID-19 (EAVE II)
Davies Adeloye[SUP] 1 [/SUP], Srinivasa Vittal Katikireddi[SUP] 2 [/SUP], Lana Woolford[SUP] 1 [/SUP], Colin R Simpson[SUP] 1 3 [/SUP], Syed Ahmar Shah[SUP] 1 [/SUP], Utkarsh Agrawal[SUP] 4 [/SUP], Lewis D Richie[SUP] 5 [/SUP], Olivia V Swann[SUP] 6 [/SUP], Sarah J Stock[SUP] 1 [/SUP], Chris Robertson[SUP] 7 8 [/SUP], Aziz Sheikh[SUP] 1 [/SUP], Igor Rudan[SUP] 1 [/SUP]
Affiliations
- PMID: 35003715
- PMCID: PMC8709900
- DOI: 10.7189/jogh.11.05026
Abstract
Background: The dynamics of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission and severity of disease among children and young people (CYP) across different settings are of considerable clinical, public health and societal interest. Severe COVID-19 cases, requiring hospitalisations, and deaths have been reported in some CYP suggesting a need to extend vaccinations to these age groups. As part of the ongoing Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) study, we aim to investigate the uptake, effectiveness and safety of COVID-19 vaccines in children and young people (CYP) aged 0 to 17 years in Scotland. Specifically, we will estimate: (i) uptake of vaccines against COVID-19, (ii) vaccine effectiveness (VE) against the outcomes of symptomatic SARS-CoV-2 infection, hospitalisation, intensive care unit (ICU) admissions, and death; (iii) VE for first/second dose timing among different age groups and risk groups; and (iv) the safety of vaccines.
Methods and analysis: We will conduct an open prospective cohort study classifying exposure as time-varying. We will compare outcomes amongst first dose vaccinated and second dose vaccinated CYP to those not yet vaccinated. A Test Negative Design (TND) case control study will be nested within this national cohort to investigate VE against symptomatic infection. The primary outcomes will be (i) uptake of vaccines against COVID-19, (ii) time to COVID-19 infection, hospitalisation, ICU admissions or death, and (iii) adverse events related to vaccines. Vaccination status (unvaccinated, one dose and two doses) will be defined as a time-varying exposure. Data from multiple sources will be linked using a unique identifier. We will conduct descriptive analyses to explore trends in vaccine uptake, and association between different exposure variables and vaccine uptake will be determined using multivariable logistic regression models. VE will be assessed from time-dependent Cox models or Poisson regression models, adjusted for relevant confounders, including age, sex, socioeconomic status, and comorbidities. We will employ self-controlled study designs to determine the risk of adverse events following COVID-19 vaccination.
Ethics and dissemination: Ethics approval was obtained from the National Research Ethics Committee, South East Scotland 02. We will present findings of this study at international conferences, in peer-reviewed journals and to policy-makers.