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

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

doi:10.1016/j.lanepe.2022.100513

Cited by 11 publications

(21 citation statements)

References 62 publications

(131 reference statements)

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“…This suggests that COVID-19 vaccination in adolescents is safe. These findings add to, and extend upon, those from a nationwide study in Scotland, reporting no association between vaccination and increased risk of hospital stay for 17 different diagnoses among adolescents [5]. The present study also estimated that 2 doses of mRNA vaccine had about 76% effectiveness against hospitalisation due to COVID-19.…”

Section: Discussionsupporting

confidence: 82%

“…Limited sample sizes also hindered the evaluation of the level of protection against severe Coronavirus Disease 2019 (COVID-19), such as hospitalisation, which could be estimated using large-scale observational studies. These studies also offer the possibility of investigating any potential links between vaccination and rare serious adverse events, such as myocarditis [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and effectiveness of monovalent COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Ballin

Nordström

2023

PLoS Med

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Background Real-world evidence on the safety and effectiveness of Coronavirus Disease 2019 (COVID-19) vaccination against severe disease caused by the omicron variant among adolescents is sparse. In addition, evidence on risk factors for severe COVID-19 disease, and whether vaccination is similarly effective in such risk groups, is unclear. The aim of the present study was therefore to examine the safety and effectiveness of monovalent COVID-19 mRNA vaccination against COVID-19 hospitalisation, and risk factors for COVID-19 hospitalisation in adolescents. Methods and findings A cohort study was conducted using Swedish nationwide registers. The safety analysis included all individuals in Sweden born between 2003 and 2009 (aged 11.3 to 19.2 years) given at least 1 dose of monovalent mRNA vaccine (N = 645,355), and never vaccinated controls (N = 186,918). The outcomes included all-cause hospitalisation and 30 selected diagnoses until 5 June 2022. The vaccine effectiveness (VE) against COVID-19 hospitalisation, and risk factors for hospitalisation, were evaluated in adolescents given 2 doses of monovalent mRNA vaccine (N = 501,945), as compared to never vaccinated controls (N = 157,979), for up to 5 months follow-up during an omicron predominant period (1 January 2022 to 5 June 2022). Analyses were adjusted for age, sex, baseline date, and whether the individual was born in Sweden. The safety analysis showed that vaccination was associated with 16% lower (95% confidence interval (CI) [12, 19], p < 0.001) risk of all-cause hospitalisation, and with marginal differences between the groups regarding the 30 selected diagnoses. In the VE analysis, there were 21 cases (0.004%) of COVID-19 hospitalisation among 2-dose recipients and 26 cases (0.016%) among controls, resulting in a VE of 76% (95% CI [57, 87], p < 0.001). Predominant risk factors for COVID-19 hospitalisation included previous infections (bacterial infection, tonsillitis, and pneumonia) (odds ratio [OR]: 14.3, 95% CI [7.7, 26.6], p < 0.001), and cerebral palsy/development disorders (OR: 12.7, 95% CI [6.8, 23.8], p < 0.001), with similar estimates of VE in these subgroups as in the total cohort. The number needed to vaccinate with 2 doses to prevent 1 case of COVID-19 hospitalisation was 8,147 in the total cohort and 1,007 in those with previous infections or developmental disorders. None of the individuals hospitalised due to COVID-19 died within 30 days. Limitations of this study include the observational design and the possibility of unmeasured confounding. Conclusions In this nationwide study of Swedish adolescents, monovalent COVID-19 mRNA vaccination was not associated with an increased risk of any serious adverse events resulting in hospitalisation. Vaccination with 2 doses was associated with a lower risk of COVID-19 hospitalisation during an omicron predominant period, also among those with certain predisposing conditions who should be prioritised for vaccination. However, COVID-19 hospitalisation in the general population of adolescents was extremely rare, and additional doses in this population may not be warranted at this stage.

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Section: Discussionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of monovalent COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Ballin

Nordström

2023

PLoS Med

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“…These findings add to, and extend upon those from a nationwide study in Scotland, reporting no association between vaccination and increased risk of hospital stay for 17 different diagnoses among adolescents. [5] The present study also estimated that two doses of mRNA vaccine had about 75% effectiveness against hospitalisation due to COVID-19. Similar estimates were reported in two case-control studies of adolescents conducted in the US and Brazil during an omicron predominant period, where VE against COVID-19 hospitalisation or death was about 80%.…”

Section: Discussionsupporting

confidence: 57%

Section: Introductionmentioning

confidence: 99%

“…These studies also offer the possibility of investigating any potential links between vaccination and rare serious adverse events, such as myocarditis, for which the data appear inconsistent. [4,5] Currently, there is limited data on vaccine effectiveness (VE) against severe COVID-19 caused by the omicron variant among adolescents. Two case-control studies found that two doses of the BNT162b2 mRNA vaccine had about 80% VE against COVID-19 hospitalisation or death in adolescents.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and effectiveness of COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Ballin

Nordström

2022

Preprint

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BackgroundReal-world evidence on the safety and effectiveness of COVID-19 vaccination against severe disease caused by the omicron variant among adolescents is sparse. In addition, evidence on risk factors for severe COVID-19 disease, and whether vaccination is similarly effective in such risk groups, is unclear.Methods and findingsNationwide registers were used to examine the safety and effectiveness of COVID-19 mRNA vaccination against COVID-19 hospitalisation, and risk factors for COVID-19 hospitalisation in adolescents. The safety analysis included all individuals in Sweden born between 2003-2009 (aged 11.3-19.2 years) given at least one dose of mRNA vaccine (N=645,355), and never vaccinated controls (N=199,022). Outcomes evaluated included all hospitalisations until 5 June 2022. The vaccine effectiveness (VE) against COVID-19 hospitalisation and associated risk factors was evaluated in adolescents given two doses of mRNA vaccine (N=501,945), as compared to never vaccinated controls (N=170,083), during an omicron predominant period (1 January 2022 to 5 June 2022). The safety analysis showed that COVID-19 mRNA vaccination was not associated with an increased risk of any serious adverse events resulting in hospitalisation. During follow-up, 1.69% of the vaccinated individuals were hospitalised compared to 1.71% of the controls (P=0.29). In the VE analysis, there were 21 cases (0.004%) of COVID-19 hospitalisation among 2-dose recipients and 26 cases (0.015%) among controls, resulting in an estimated VE of 75% (95% CI, 54-86, P<0.001). Strong risk factors for COVID-19 hospitalisation included previous infections (odds ratio [OR], 14.3, 95% CI, 7.7-26.6, P<0.001), and cerebral palsy/development disorders (OR, 12.0, 95% CI, 6.4-22.6, P<0.001), with similar estimates of VE in these subgroups as in the total cohort. The number needed to vaccinate with two doses to prevent one case of COVID-19 hospitalisation was 9,007 in the total cohort and 1,031 in those with previous infections or developmental disorders. None of the individuals hospitalised due to COVID-19 died within 30 days.ConclusionsIn this nationwide study, COVID-19 mRNA vaccination was not associated with an increased risk of any serious adverse event in adolescents. Two doses were associated with a lower risk of COVID-19 hospitalisation during the omicron predominant period, especially among those with certain predisposing conditions who should be prioritized for vaccination. However, COVID-19 hospitalisation among general adolescents was extremely rare, and additional doses in this population may not be warranted at this stage.Why was this study doneEvidence before this study➢There is limited evidence on the effectiveness of COVID-19 vaccination against severe outcomes during the omicron era among adolescents. In addition, there is lack of data on whether certain groups of adolescents are at greater risk of severe COVID-19 and should be prioritized in vaccination programs, and whether vaccination is equally effective in such risk groups.➢Regarding safety, some studies have indicated a link between COVID-19 mRNA vaccination and increased risk of myocarditis and pericarditis in young men, although the data appear inconsistent.What did the researchers do and find?➢Using Swedish nationwide health registers, a cohort of 844,377 adolescents were followed until 5 June 2022 to evaluate the safety and effectiveness of COVID-19 mRNA vaccination against COVID-19 hospitalisation, and risk factors for COVID-19 hospitalisation.➢COVID-19 mRNA vaccination in adolescents was not associated with an increased risk of any diagnoses resulting in hospitalisation. In contrast, two doses of vaccine had an associated 75% effectiveness against COVID-19 hospitalisation. However, only about 6 individuals in 100,000 were hospitalised due to COVID-19 during follow-up.➢There were certain strong risk factors for COVID-19 hospitalisation, such as previous infections and different development disorders, which increased the risk of COVID-19 hospitalisation more than tenfold. Vaccine effectiveness among these individuals was similar as in the rest of the cohort.What do these findings mean?➢Although COVID-19 mRNA vaccination appears safe and associated with reduced risk of COVID-19 hospitalisation, the risk of severe COVID-19 seems to be extremely low in general adolescents. Therefore, administration of additional doses to the general population of adolescents may not be warranted at this stage of the pandemic. In contrast, individuals with a high risk for severe COVID-19 should be prioritised for vaccination.

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Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity

et al. 2023

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ImportanceEstimates of the rate of waning of vaccine effectiveness (VE) against COVID-19 are key to assess population levels of protection and future needs for booster doses to face the resurgence of epidemic waves.ObjectiveTo quantify the progressive waning of VE associated with the Delta and Omicron variants of SARS-CoV-2 by number of received doses.Data SourcesPubMed and Web of Science were searched from the databases’ inception to October 19, 2022, as well as reference lists of eligible articles. Preprints were included.Study SelectionSelected studies for this systematic review and meta-analysis were original articles reporting estimates of VE over time against laboratory-confirmed SARS-CoV-2 infection and symptomatic disease.Data Extraction and SynthesisEstimates of VE at different time points from vaccination were retrieved from original studies. A secondary data analysis was performed to project VE at any time from last dose administration, improving the comparability across different studies and between the 2 considered variants. Pooled estimates were obtained from random-effects meta-analysis.Main Outcomes and MeasuresOutcomes were VE against laboratory-confirmed Omicron or Delta infection and symptomatic disease and half-life and waning rate associated with vaccine-induced protection.ResultsA total of 799 original articles and 149 reviews published in peer-reviewed journals and 35 preprints were identified. Of these, 40 studies were included in the analysis. Pooled estimates of VE of a primary vaccination cycle against laboratory-confirmed Omicron infection and symptomatic disease were both lower than 20% at 6 months from last dose administration. Booster doses restored VE to levels comparable to those acquired soon after the administration of the primary cycle. However, 9 months after booster administration, VE against Omicron was lower than 30% against laboratory-confirmed infection and symptomatic disease. The half-life of VE against symptomatic infection was estimated to be 87 days (95% CI, 67-129 days) for Omicron compared with 316 days (95% CI, 240-470 days) for Delta. Similar waning rates of VE were found for different age segments of the population.Conclusions and RelevanceThese findings suggest that the effectiveness of COVID-19 vaccines against laboratory-confirmed Omicron or Delta infection and symptomatic disease rapidly wanes over time after the primary vaccination cycle and booster dose. These results can inform the design of appropriate targets and timing for future vaccination programs.

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

Cited by 11 publications

References 62 publications

Safety and effectiveness of monovalent COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Safety and effectiveness of monovalent COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Safety and effectiveness of COVID-19 mRNA vaccination and risk factors for hospitalisation caused by the omicron variant in 0.8 million adolescents: A nationwide cohort study in Sweden

Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity

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