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Contributing participants, total person-days, number of RT-PCR-confirmed SARS-CoV-2 infections by vaccination status, and estimated Pfizer-BioNTech COVID-19 vaccine effectiveness for full vaccination in preventing infection among vaccine-eligible adolescents aged 12-17 years (N = 243) -Arizona, July-December 2021
Source publication
The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine has demonstrated high efficacy in preventing infection with SARS-CoV-2 (the virus that causes COVID-19) in randomized placebo-controlled Phase III trials in persons aged 12-17 years (referred to as adolescents in this report) (1); however, data on real-word vaccine effectiveness (VE) among adoles...
Contexts in source publication
Context 1
... = 9.0) compared with those who received negative test results (61.3%; SE = 2.7) (p = 0.003). During the study period, 66 participants contributed 4,288 unvaccinated person-days, 30 contributed 909 partially vaccinated person-days, and 190 contributed 21,693 fully vaccinated person-days (Table 2). Most (n = 171, 70.3%) vaccinated participants entered the study fully vaccinated. ...Context 2
... the 4,288 unvaccinated person-days, 16 RT-PCRconfirmed infections were identified (incidence rate = 3.73 per 1,000 person-days) ( Table 2). During the 909 person-days <14 days after receipt of the second vaccine dose, when persons were considered partially vaccinated, no RT-PCR-confirmed infections were identified. ...Context 3
... = 9.0) compared with those who received negative test results (61.3%; SE = 2.7) (p = 0.003). During the study period, 66 participants contributed 4,288 unvaccinated person-days, 30 contributed 909 partially vaccinated person-days, and 190 contributed 21,693 fully vaccinated person-days (Table 2). Most (n = 171, 70.3%) vaccinated participants entered the study fully vaccinated. ...Context 4
... the 4,288 unvaccinated person-days, 16 RT-PCRconfirmed infections were identified (incidence rate = 3.73 per 1,000 person-days) ( Table 2). During the 909 person-days <14 days after receipt of the second vaccine dose, when persons were considered partially vaccinated, no RT-PCR-confirmed infections were identified. ...Similar publications
Citations
... [15][16] Of these, 15 were on healthy adolescents and one was on 12-21 years old with rheumatic diseases on immunomodulatory treatment. 17 The variants in the studies were on Alpha and Delta in two 15,18 ; Delta in four [19][20][21][22] ; Delta and Omicron in three [23][24][25] ; two in Omicron 26,27 ; and in five studies it was not reported 16,17,[28][29][30] . The variants were based on the predominat strain at the time of the research in six studies and in another five it was detected by viral sequencing. ...
Objectives. The World Health Organization recently revised their recommendations and considered healthy children and adolescents as low priority group for COVID-19 vaccine. This review comprehensively assessed existing clinical evidence on COVID-19 vaccine in 12-17 years old. Methods. Included in this review were any type of study that investigated the efficacy, immunogenicity, safety, and effectiveness of COVID-19 vaccine on protection against SARS-COV-2 infection in 12-17 years old. Various electronic databases were searched up to March 15, 2023. Studies were screened, data extracted, risk of bias appraised, and certainty of evidence was judged using GRADE. Review Manager 5.4 was used to estimate pooled effects. Difference between the two groups was described as mean difference for continuous variables and as relative risk or odds ratio for categorical variables. Results. There were six randomized controlled trials and 16 effectiveness studies (8 cohorts and 8 case control). Low certainty evidence showed that BNT162b2 (Pfizer) was effective, immunogenic, and safe in healthy adolescents. There were 15 effectiveness studies on BNT162b2 (Pfizer) in healthy adolescent and one on immunocompromised patients. It was protective against infection with any of the variants, with higher protection against Delta than Omicron. BNT162b2 is protective against hospitalization and emergency and urgent care (high certainty); and critical care and MIS-C (low). Very low certainty evidence noted that BNT 162b2 was also immunogenic in 12-21 years old with rheumatic diseases while on immunomodulatory treatment but with possible increased exacerbation of illness. Low certainty evidence demonstrated that mRNA-1273 (Moderna) was effective, immunogenic, and safe. Low to very low certainty evidence were noted on the safety and immunogenicity of two vector base vaccines (ChAdOx1-19 and Ad5 vector COVID vaccine) and two inactivated vaccines (CoronaVac and BBIBP CorV). Conclusion. There is presently low certainty evidence on the use of RNA vaccines in 12-17 years old. Therecommendation on its use is weak. There is presently insufficient evidence for the use of inactivated andvector-based COVID-19 vaccines. Different countries should consider whether to vaccinate healthy adolescentwithout comprising the other recommended immunization and health priorities that are crucial for this agegroup. Other factors including cost-effectiveness of vaccination and disease burden should be accounted.
... We obtained 2233 records from MEDLINE (accessed through PubMed), Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov. Four hundred twenty-five published reports were assessed for full-text eligibility after Table 2) [20][21][22][23][24][25][26][27][28][29]. There were different study designs for included studies, 5 cohort studies (527,778 participants) [22,[24][25][26]28] and 5 case-control studies (147,7422 participants) [20,21,23,27,29]. ...
... Four hundred twenty-five published reports were assessed for full-text eligibility after Table 2) [20][21][22][23][24][25][26][27][28][29]. There were different study designs for included studies, 5 cohort studies (527,778 participants) [22,[24][25][26]28] and 5 case-control studies (147,7422 participants) [20,21,23,27,29]. In total, 2 COVID-19 vaccines (BNT162b2 and CoronaVac) and 2 VOC (Delta and Omicron) were included in this study. ...
This systematic review and meta-analysis aimed to evaluate the effectiveness of COVID-19 vaccines among children and adolescents against SARS-CoV-2 variants. We searched PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov for studies published on or before June 20, 2023. Studies evaluating the effectiveness of COVID-19 vaccines in children and adolescents (≤ 18 years of age) were included. Data extraction, quality assessment, and analysis were conducted following PRISMA guidelines. Ten studies were included, comprising five cohort studies (527,778 participants) and four case-control studies (1,477,422 participants). The overall vaccine effectiveness (VE) against SARS-CoV-2 variants was 68% (95% CI = 60–74%). In terms of age, the VE was higher in adolescents aged 12–18 years [69%(95% CI = 61–75%)] than in children aged 5–11 years [44%(95% CI = 1–68%)]. “Fully vaccinated” may offer greater protection than “partially vaccinated,” with a VE of 71% (95%CI = 59–79%) and 66% (95%CI = 51–76%), respectively.
Conclusion: This meta-analysis presents moderate-quality evidence that the COVID-19 vaccine is effective in safeguarding children and adolescents from the SARS-CoV-2 variant. Being fully vaccinated may offer greater protection than being partially vaccinated. Nevertheless, additional high-quality controlled trials are required to verify this finding. What is Known:
• The COVID-19 pandemic has led to the rapid development and deployment of vaccines worldwide. Children and adolescents are a unique population for vaccination, and the effectiveness of vaccines against SARS-CoV-2 variants in this age group is of concern.
What is New:
• The COVID-19 vaccine is effective in protecting children and adolescents against the SARS-CoV-2 variant. Being fully vaccinated may offer greater protection than being partially vaccinated.
... ; US population to confirm the effectiveness of the BNT162b2 vaccine in preventing hospitalization and severe illness. [25][26][27][28][29] This study had certain limitations. First data from March to November 2020 were used because the study was initiated in late 2020 and because of Institutional Review Board approval timelines, lag time for data availability, and the time required to conduct chart review, more recent data were not included. ...
Purpose: This study assessed the performance of International Classification of Diseases 10th Revision, Clinical Modification (ICD-10-CM) coronavirus disease 2019 (COVID-19) diagnostic code U07.1 against polymerase chain reaction (PCR) test results (Objective 1), and electronic medical record (EMR)-based codified algorithm for severe COVID-19 illness based on endpoints used in the Pfizer-BioNTech COVID-19 vaccine trial against chart review (Objective 2).
Methods: This retrospective, longitudinal cohort study used EMR data from the Mass General Brigham COVID-19 Data Mart (3/1/2020-11/19/2020) for adult patients with ≥1 PCR test, antigen test, or code U07.1 (Objective 1) and adult patients with a positive PCR test hospitalized with COVID-19 (Objective 2).
Results: Among 354,124 patients in Objective 1, 96% had ≥1 PCR test (including 6% with ≥1 positive PCR test; 11% with ≥1 code U07.1). Code U07.1 had low sensitivity (54%) and positive predictive value (PPV; 63%) but high specificity (97%) against the PCR test. Among 300 patients hospitalized for COVID-19 randomly sampled for chart review in Objective 2, the EMR-based case definition for severe COVID-19 illness had high PPV (>95%), showing better performance than severe/critical COVID-19 endpoints defined by the World Health Organization (PPV: 79%).
Conclusions: COVID-19 diagnosis based on ICD-10-CM code U07.1 had inadequate sensitivity and requires confirmation by PCR testing. The EMR-based case definition showed high PPV and can be used to identify cases of severe COVID-19 illness in real-world datasets. These findings highlight the importance of validating outcomes in real-world data, and can guide researchers analyzing COVID-19 data when PCR tests are not readily available.
... The BNT 162b2 (Pfizer-BioNTech) messenger RNA (mRNA) COVID-19 vaccine was granted emergency use authorization for children aged 5-11 years in October 2021 [6]. Initial reports demonstrated robust protection against infection for this age group but somewhat lower protection during the Omicron wave [7][8][9]. As of 5 April 2023, 32% of children aged 5-11 years had received 2 doses of an mRNA vaccine, either Pfizer or Moderna [7][8][9][10]. ...
... Initial reports demonstrated robust protection against infection for this age group but somewhat lower protection during the Omicron wave [7][8][9]. As of 5 April 2023, 32% of children aged 5-11 years had received 2 doses of an mRNA vaccine, either Pfizer or Moderna [7][8][9][10]. ...
Background
The PROTECT study is a longitudinal cohort study initiated in July 2021 with weekly testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 4 states: Arizona, Florida, exas, and Utah. This study aims to examine vaccine-elicited antibody response against postvaccination SARS-CoV-2 infections.
Methods
Children aged 5–11 years had serum collected 14–59 days after their second dose of monovalent Pfizer-BioNTech coronavirus disease 2019 messenger RNA vaccine. Vaccine-elicited antibodies were measured using the area under the curve (AUC) and end-point titer using enzyme-linked immunosorbent assay (receptor-binding domain [RBD] and S2) and surrogate neutralization assays against ancestral (WA1) and Omicron (BA.2).
Results
79 vaccinated participants (33 [41.7%] female; median age, 8.8 years [standard deviation, 1.9 years]), 48 (60.8%) were from Tucson, Arizona; 64 (81.0%) were non-Hispanic white; 63 (80.8%) attended school in person; 68 (86.1%) did not have any chronic conditions; and 47 (59.5%) were infected after vaccination. Uninfected children had higher AUCs against WA1 (P = .009) and Omicron (P = .02). The geometric mean and surrogate neutralization titer above the limit of detection was 346.0 for WA1 and 39.7 for Omicron, an 8.7-fold decrease (P < .001). After adjustment of covariates in the WA1-specific model, we observed a 47% reduction in the odds of postvaccination infection for every standard deviation increase in RBD AUC (aOR, 0.53 [95% confidence interval, .29–.97) and a 69% reduction in the odds of infection for every 3-fold increase in RBD end titer (0.31 [.06–1.57]).
Conclusions
Children with higher antibody levels experienced a lower incidence of postvaccination SARS-CoV-2 infection.
... The registration trials for pediatric populations have shown excellent safety, immunogenicity and efficacy profiles [45][46][47][48][49]. However, the vaccine efficacy and effectiveness in real life have changed as a result of the circulation of new viral variants [50,51]. This explains the slight decrease in efficacy compared to the registration trials, although the data even in real life must absolutely encourage the implementation of vaccination strategies for those of pediatric ages [52,53]. ...
The clinical aspects of SARS-CoV-2 infection, as well as the COVID-19 vaccines’ safety, efficacy and effectiveness in pediatric patients with asthma, are crucial to adapting clinical management in this fragile population and for prevention strategies. The aim of this narrative review was to evaluate the impact of SARS-CoV-2 infection in children with asthma and the impact of COVID-19 vaccination. Systematic research using the principal medical databases was conducted using specific search query strings from the early spreading of COVID-19 globally until March 2023; further relevant data were drawn from the main national and supranational institutions. No significant differences in SARS-CoV-2 incidence and morbidity were found in asthmatic pediatric patients compared to non-asthmatic ones; however, subjects with uncontrolled asthma were found to be at increased risk of developing a serious disease during SARS-CoV-2 infection. Regarding COVID-19 vaccines, accumulating data support their safety, efficacy and effectiveness on asthmatic children regardless of asthma severity. Further cohort-based studies are needed as the evidence of new epidemic waves caused by new viral variants makes the current knowledge outdated.
... The concomitant re-uptake of water with sodium reabsorption prompts an increase in blood pressure [39] Potassium is the predominant intracellular ion, that is majorly involved in regulation of cell membrane polarity. A hyper-polarized cell membrane tends to be depolarized faster than normal, causing aberrancy in the function of cardiac cells [40] In a recent cohort study, infertile patient diagnosed with COVID-19 were categorized into three groups: severe hypokalemia, hypokalemia, and normokalemia. The study reported that 93% of infertilepatient with a severe clinical condition had hypokalemia. ...
The SARS-CoV-2 virus, which is the causative agent of the recent pandemic known as COVID-19, includes information about its characteristics, origin, transmission, clinical symptoms, diagnosis protocol, transmission, potential treatment protocol, and available vaccinations that are currently in effect between patients visiting fertility centers. From asymptomatic to mild, moderate, and very severe cases, COVID-19 encompasses a range of clinical manifestations, and many things remain unclear to this day. Each of these cases has a unique immunology, which gets more complicated when the infertile patient develops a serious illness. Monitoring lymphopenia is crucial since it is a major mechanism in the etiology, a biomarker of the progression of severity, and a target for treatment. High viral loads at the time of the initial infection and recurrent viral exposure, particularly in infertile patients and healthcare professionals, can significantly increase the severity of the infection and should be rigorously avoided.
... Previous research has demonstrated that a combination of naturally acquired immunity through multiple reinfections and vaccine-induced immunity confers significant protection against severe SARS-CoV-2 disease and mortality [20,[37][38][39]. Irrespective of the prevailing virus variant, the most significant risk factor for reinfection was found to be a lack of vaccination [26,40]. ...
Reinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants due to immune escape is challenging for the global response to the pandemic. We estimated the Omicron reinfection prevalence among people who had a previous SARS-CoV-2 infection in Shanghai, China. We conducted a telephone survey in December 2022 with those who had previously been infected with Omicron between March and May 2022. Information on their demographics, coronavirus disease 2019 (COVID-19) testing, and vaccination history was collected. The overall and subgroup reinfection rates were estimated and compared. Among the 1981 respondents who were infected between March and May 2022, 260 had positive nucleic acid or rapid antigen tests in December 2022, with an estimated reinfection rate of 13.1% (95% confidence interval [95% CI]: 11.6–14.6). The reinfection rate for those who had a booster vaccination was 11.4% (95% CI: 9.2–13.7), which was significantly lower than that for those with an incomplete vaccination series (15.2%, 95% CI: 12.3–18.1) (adjusted odds ratio [aOR]: 0.579; 95% CI: 0.412–0.813). Reinfection with the Omicron variant was lower among individuals with a previous SARS-CoV-2 infection and those who had a booster vaccination, suggesting that hybrid immunity may offer protection against reinfection with Omicron sublineages.
... Previous research has demonstrated that a combination of naturally acquired immunity through multiple reinfections and vaccine-induced immunity confers significant protection against severe SARS-CoV-2 disease and mortality [20,[35][36][37]. Irrespective of the prevailing virus variant, the most significant risk factor for reinfection was found to be the absence of vaccination [25,38]. ...
Reinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants due to immune escape challenges the global response to the pandemic. We estimated the Omicron reinfection prevalence among people who had previous SARS-CoV-2 infections in Shanghai, China. We conducted a telephone survey in December 2022 for those who were previously infected with Omicron between March and May 2022. Information on demographics, coronavirus disease 2019 (COVID-19) testing, and vaccination history was collected. The overall and subgroup reinfection rates were estimated and compared. Among the 1981 respondents who were infected between March and May 2022, 260 had positive nucleic acid or rapid antigen tests in December 2022, with an estimated reinfection rate of 13.1% (95% confidence interval [95% CI]: 11.6-14.6). The reinfection rate for those who had a booster vaccination was 11.4% (95% CI: 9.2-13.7), which was significantly lower than that for those with an incomplete vaccination series (15.2%, 95% CI: 12.3-18.1) (adjusted odds ratio [aOR]: 0.579; 95% CI: 0.412–0.813). Reinfection with the Omicron variant was lower among individuals with previous SARS-CoV-2 infection and had completed a booster vaccination, suggesting that hybrid immunity can offer better protection against reinfection with Omicron sublineages.
... 21,22 Seven studies of real-life vaccine effectiveness in children and adolescents have been published, including the period when Delta and Omicron SARS-CoV-2 variants were predominant. [24][25][26][27][28][29][30][31] In general, mRNA vaccines have shown moderate to good protection against symptomatic COVID-19 among children but are effective in preventing severe disease. 23,24,[27][28][29][30][31] Two studies ...
... [24][25][26][27][28][29][30][31] In general, mRNA vaccines have shown moderate to good protection against symptomatic COVID-19 among children but are effective in preventing severe disease. 23,24,[27][28][29][30][31] Two studies ...
Background:
Policymakers urgently need evidence to adequately balance the costs and benefits of mass vaccination against COVID-19 across all age groups, including children and adolescents. In this study, we aim to assess the effectiveness of CoronaVac's primary series among children and adolescents in Chile.
Methods:
We used a large prospective national cohort of about two million children and adolescents 6-16 years to estimate the effectiveness of an inactivated SARS-CoV-2 vaccine (CoronaVac) in preventing laboratory-confirmed symptomatic SARS-CoV-2 infection (COVID-19), hospitalisation, and admission to an intensive care unit (ICU) associated with COVID-19. We compared the risk of individuals treated with a complete primary immunization schedule (two doses, 28 days apart) with the risk of unvaccinated individuals during the follow-up period. The study was conducted in Chile from June 27, 2021, to January 12, 2022, when the SARS-CoV-2 Delta variant was predominant but other variants of concern were co-circulating, including Omicron. We used inverse probability-weighted survival regression models to estimate hazard ratios of complete immunization over the unvaccinated status, accounting for time-varying vaccination exposure and adjusting for relevant demographic, socioeconomic, and clinical confounders.
Findings:
The estimated adjusted vaccine effectiveness for the inactivated SARS-CoV-2 vaccine in children aged 6-16 years was 74.5% (95% CI, 73.8-75.2), 91.0% (95% CI, 87.8-93.4), 93.8% (95% CI, 87.8-93.4) for the prevention of COVID-19, hospitalisation, and ICU admission, respectively. For the subgroup of children 6-11 years, the vaccine effectiveness was 75.8% (95% CI, 74.7-76.8) for the prevention of COVID-19 and 77.9% (95% CI, 61.5-87.3) for the prevention of hospitalisation.
Interpretation:
Our results suggest that a complete primary immunization schedule with the inactivated SARS-CoV-2 vaccine provides effective protection against severe COVID-19 disease for children 6-16 years.
Funding:
Agencia Nacional de Investigación y Desarrollo (ANID) Millennium Science Initiative Program and Fondo de Financiamiento de Centros de Investigación en Áreas Prioritarias (FONDAP).
... [4][5][6][7][8][9][10][11][12][13] Additionally, COVID-19 vaccination rates in children vary by geography and age, necessitating exploring the impact of vaccination across ages. [15][16][17][18][19][20][21][22][23][24] Harnessing a large, multisite, national, USbased electronic health record (EHR)-based dataset, we evaluated which clinical and demographic factors (including variant and vaccination) are associated with severe outcomes in children with COVID-19. ...
Objectives:
Throughout the pandemic, children with COVID-19 have experienced hospitalization, ICU admission, invasive respiratory support, and death. Using a multisite, national dataset, we investigate risk factors associated with these outcomes in children with COVID-19.
Methods:
Our data source (Optum deidentified COVID-19 Electronic Health Record Dataset) included children aged 0 to 18 years testing positive for COVID-19 between January 1, 2020, and January 20, 2022. Using ordinal logistic regression, we identified factors associated with an ordinal outcome scale: nonhospitalization, hospitalization, or a severe composite outcome (ICU, intensive respiratory support, death). To contrast hospitalization for COVID-19 and incidental positivity on hospitalization, we secondarily identified patient factors associated with hospitalizations with a primary diagnosis of COVID-19.
Results:
In 165 437 children with COVID-19, 3087 (1.8%) were hospitalized without complication, 2954 (1.8%) experienced ICU admission and/or intensive respiratory support, and 31 (0.02%) died. We grouped patients by age: 0 to 4 years old (35 088), and 5 to 11 years old (75 574), 12 to 18 years old (54 775). Factors positively associated with worse outcomes were preexisting comorbidities and residency in the Southern United States. In 0- to 4-year-old children, there was a nonlinear association between age and worse outcomes, with worse outcomes in 0- to 2-year-old children. In 5- to 18-year-old patients, vaccination was protective. Findings were similar in our secondary analysis of hospitalizations with a primary diagnosis of COVID-19, though region effects were no longer observed.
Conclusions:
Among children with COVID-19, preexisting comorbidities and residency in the Southern United States were positively associated with worse outcomes, whereas vaccination was negatively associated. Our study population was highly insured; future studies should evaluate underinsured populations to confirm generalizability.
