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Oral Health Surveys: Basic Methods

Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: A narrative review.

http://manuscript.elsevier.com/S1198743X21006042/pdf/S1198743X21006042.pdf

Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: a narrative review

Background Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. Methods A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. Results During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). Conclusions A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2116298

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.). 

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2116298?articleTools=true

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

In Israel, the BNT162b2 vaccine against severe acute respiratory syndrome coronavirus 2 was approved for use in adolescents in June 2021, shortly before an outbreak of B.1.617.2 (Delta) variant-dominant infection. We evaluated short-term vaccine effectiveness and found the vaccine to be highly effective among this population in this setting.

Effectiveness of BNT162b2 Vaccine in Adolescents during Outbreak of SARS-CoV-2 Delta Variant Infection, Israel, 2021.

Myocarditis after BNT162b2 Vaccination in Israeli Adolescents

Objective Persistent hypertension in adulthood is a leading cause of end-stage renal disease (ESRD). Whether lower blood pressure (BP) values, in the range of prehypertension, are also associated with future occurrence of ESRD is unclear. Even less clear is the potential risk of early prehypertension appearing in adolescence. To address this question, we examined whether BP measurements in the prehypertensive range at age 16-19 years predict adult ESRD. Methods Medical data on 2194 635 16-19-year-old adolescents examined for medical fitness prior to military service from 1977 to 2013 were linked to the Israeli ESRD registry in this nationwide population-based cohort study. Incident cases of ESRD were recorded. Survival models were applied. Results During 35 007 506 person-years of follow-up (median follow-up 16.8 years), there were 690 ESRD cases, with an overall incidence rate of 1.97 cases per 100 000 person-years. Examinees with elevated BP readings in the prehypertensive range (BP between the 90th and 95th percentiles or between 120 and 139/80-89 mmHg) had increased incidence of ESRD with a hazard ratio of 1.32 (95% confidence interval, 1.11-1.58) adjusted for year of birth, age at examination, sex, BMI, education, socioeconomic status, and country of origin. Hypertension (BP above the 95th percentile or above 140/90 mmHg) was associated with a hazard ratio of 1.44 (95% confidence interval, 1.17-1.79). A spline model demonstrated a nadir of risk at SBP values as low as 94 mmHg. Conclusion Asymptomatic, healthy adolescents with prehypertension have a 32% increased risk for subsequent ESRD, compared with adolescents with optimal BP.

Prehypertension among 2.19 million adolescents and future risk for end-stage renal disease.

We studied the 2-year death rate of 246 adults discharged from hospital after experiencing acute West Nile Virus infection in Israel during 2000. The age- and sex-adjusted death rates were significantly higher than in the general population. This excess was greater for men. Significant adverse prognostic factors were age, male sex, diabetes mellitus, and dementia.

/pdf/long-term-death-rates-west-nile-virus-epidemic-israel-2000-33m08ve1my.pdf

Long-term Death Rates, West Nile Virus Epidemic, Israel, 2000

Objective

To assess the trends in the incidence of type 1 diabetes between 1997 and 2010 among 0–17-yr-old Israeli Jews and Arabs compared with global trends.



Methods

Data on children with newly diagnosed type 1 diabetes reported by pediatric endocrinologists from 19 medical centers to the Israel Center for Disease Control, as part of the National Diabetes Register.



Results

During 1997–2010, 2857 Jews and 757 Arabs were diagnosed with type 1 diabetes. The average age-adjusted incidence among Jews was higher than Arabs [12.2 per 100 000, 95% confidence interval (CI) 10.5–14.2 and 8.9 per 100 000, 95% CI 7.5–10.7, p = 0.0001, respectively], however, the annual percent change was higher for Arabs compared with Jews (4.0 vs. 3.6%, p = 0.005, respectively). The mean age at diagnosis was similar for Jews and Arabs (9.6 ± 4.4 vs. 9.9 ± 4.4 yr, p = 0.08), and it remained stable during 1997–2010 in both ethnic groups (p = 0.6). In both Jews and Arabs the highest annual percent change was observed in younger children. It was 4.9% for children aged 5–9 yr and 10.7% for children aged 0–4 yr, respectively. There were no differences in the frequency of diabetic ketoacidosis (DKA) between Jews (39.9%) and Arabs (41.3%), (p = 0.5).



Conclusion

Type 1 diabetes incidence of Jews and Arabs in Israel is increasing. The incidence is higher in Jews than in Arabs; however, the annual percent change is higher in Arabs than in Jews. In both Ethnic groups the incidence of type 1 diabetes is increasing especially among young children.

Rita Dichtiar

Papers

Effectiveness of BNT162b2 Vaccine in Adolescents during Outbreak of SARS-CoV-2 Delta Variant Infection, Israel, 2021.

Myocarditis after BNT162b2 Vaccination in Israeli Adolescents

Prehypertension among 2.19 million adolescents and future risk for end-stage renal disease.

Long-term Death Rates, West Nile Virus Epidemic, Israel, 2000

Trends in the incidence of type 1 diabetes among Jews and Arabs in Israel.