Pfizer COVID19 vaccine is not associated with acute cardiovascular events excluding myocarditis- a national self-controlled case series study.

BACKGROUND: Despite publications assuring no increased risk for acute cardiovascular events (excluding myocarditis) and sudden death following administration of COVID19 vaccines, these issues still stir much public ado. We assessed the risk for acute cardiovascular events that require hospitalization (excluding myocarditis) and for mortality in the short-term following administration of the second dose of the Pfizer COVID19 vaccine in Israel. METHODS: Using a self-controlled case series (SCCS) study design and national databases, all second-dose vaccinees, who had not been diagnosed with COVID19 and who had an acute cardiovascular event (acute myocardial infarction/acute stroke/acute thromboembolic event) that required hospitalization in the 60 days following vaccine administration between Jan 11th, 2021 and Oct 31st 2021, were included. A similar analysis was carried out for mortality. The first 30 days following vaccination were defined as risk period while the next 30 days were defined as control period. The probability for an event between these periods was compared using a conditional logistic regression model, accounting for sex, age group, background morbidity and seasonal risk. RESULTS: Out of 5,700,112  second dose vaccinees, 4,163 had an acute cardiovascular event in the 60 days following vaccine administration. Following exclusion of 106 due to technical considerations, 1,979 events occurred during the risk period and 2,078 during the control period: Odds ratio, OR = 0.95, 95% confidence interval, CI 0.90-1.01, p = 0.12. Adjusted OR was similar (OR = 0.88, 95%CI 0.72-1.08). Stratifying by age showed no increased risk in any age group. Mortality assessment indicated low number of events in both periods. These results were consistent in sensitivity analyses. CONCLUSIONS: There was no increased risk for acute cardiovascular events (excluding myocarditis) in the risk period compared to the control period following administration of the second dose of Pfizer COVID19 vaccine. Mortality data raised no concerns either, but may have been biased.

Exposure to Holocaust is associated with chronic morbidity in older adults-Results from national health and nutrition surveys.

BACKGROUND: Although studies have suggested that Holocaust survivors are more likely than their non-Holocaust-exposed counterparts to suffer from mental and chronic morbidity, methodology differences and potential confounders often compromise result replicability and external validity. We examined associations between Holocaust exposure and chronic morbidity, as well as overall risk of mortality. METHODS: Sociodemographic, health-related behavior and nutritional-intake data from two representative National Health and Nutrition Survey Ages 65 and Over-the 2005-2006 MABAT ZAHAV 1 (MZ1) and the 2014-2015 MZ2, including face-to-face interviews and anthropometric measurements-were analyzed. Demographic, health, nutritional and lifestyle characteristics, and exposure to the Holocaust were self-reported. Longitudinal data on overall mortality were obtained by linking the MZ1 population to the population registry dataset. Associations between Holocaust exposure and prevalence of chronic morbidity and risk factors were estimated by multivariable logistic regression analyses, and to risk of overall mortality by Cox regression analysis, both adjusted to significant covariates. RESULTS: Among 2096 study participants aged 75.7 ± 6.1 years, 47.0% male, 518 were Holocaust survivors. In the fully adjusted model, Holocaust exposure was associated with increased prevalence of heart disease (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.07-1.83), metabolic syndrome (OR 2.28, CI 1.23-4.21), and stroke (OR 1.77, CI 1.17-2.69), but not cancer or osteoporosis. Holocaust exposure did not substantially affect the overall risk of mortality (hazard ratio 1.10, CI 0.92-1.32). CONCLUSIONS: Further research is needed to understand the mechanisms governing long-term outcomes of exposure to acute physical or mental trauma.

Attention-deficit hyperactivity disorder is associated with disordered eating in adolescents.

AIM: Attention-deficit hyperactivity disorder (ADHD) and disordered eating (DE) are both highly prevalent among adolescents, but their relationship is understudied. This study examines their possible association in a nationally representative sample of adolescents. METHODS: Participants in the Israeli Youth Health and Nutrition Survey (2015-2016), a cross-sectional, school-based study, completed self-administered questionnaires, including the SCOFF questionnaire, and underwent anthropometric measurements. An affirmative reply to at least two SCOFF items was considered a DE case. Multivariable logistic regression evaluated the ADHD-DE association and the associations between ADHD and individual SCOFF items, controlling for age, sex, socioeconomic status, and body mass index. RESULTS: Of 4616 participants (12-18 years, 50.2% male), 654 reported an ADHD diagnosis. DE prevalence among ADHD adolescents was significantly higher than the non-ADHD group (50.2% vs. 43.9%, p = 0.003). Controlling for potential covariates, the association between ADHD and DE remained significant (OR = 1.409; 95% CI: 1.170-1.697), as did associations between ADHD and three SCOFF items. No difference in DE prevalence was found between stimulant-treated (n = 287) and untreated (n = 326) adolescents with ADHD. CONCLUSION: Adolescents with ADHD are more likely to experience DE. As DE can herald an imminent eating disorder, early identification is crucial. Further studies are needed to determine the ADHD-DE relationship's causality. IMPACT: Disordered eating (DE) and attention-deficit hyperactivity disorder (ADHD) are common among adolescents, and significantly affect health and well-being. This study examined the association between ADHD and DE in adolescents using the SCOFF questionnaire. Following adjustment for sociodemographic variables and BMI z-score, ADHD was associated with a 41% increased odds for DE. This study established the association between ADHD and DE, using a well-known questionnaire, in a large, nationally representative sample of adolescents. Monitoring eating behaviors and attitudes among adolescents with ADHD should be a priority, to minimize the risk of developing an eating disorder and its harmful consequences.

Effectiveness of BNT162b2 Vaccine against Omicron Variant Infection among Children 5-11 Years of Age, Israel.

We assessed effectiveness of the BNT162b2 vaccine against infection with the B.1.1.529 (Omicron) variant (mostly BA.1 subvariant), among children 5-11 years of age in Israel. Using a matched case-control design, we matched SARS-CoV-2-positive children (cases) and SARS-CoV-2-negative children (controls) by age, sex, population group, socioeconomic status, and epidemiologic week. Vaccine effectiveness estimates after the second vaccine dose were 58.1% for days 8-14, 53.9% for days 15-21, 46.7% for days 22-28, 44.8% for days 29-35, and 39.5% for days 36-42. Sensitivity analyses by age group and period demonstrated similar results. Vaccine effectiveness against Omicron infection among children 5-11 years of age was lower than vaccine efficacy and vaccine effectiveness against non-Omicron variants, and effectiveness declined early and rapidly.

Attention-deficit hyperactivity disorder is associated with relatively short stature among adolescents.

AIM: To estimate the association between attention-deficit hyperactivity disorder (ADHD) and relatively short stature (RSS) among adolescents. METHODS: Participants in the Israeli Youth Health and Nutrition Survey (2015-2016), a cross-sectional school-based study, completed self-administered questionnaires and underwent anthropometric measurements. Height z-score < -0.7 (<25th percentile) was defined as RSS. Multivariable logistic regression analyses assessed the relation between ADHD and RSS, controlling for age, sex, body mass index (BMI) and socioeconomic status (Basic Model), and also for lifestyle factors such as physical activity, sleep duration, dietary patterns and intakes. RESULTS: Of 4173 participants (11-18 years, 50.2% males), 654 self-reported ever being diagnosed with ADHD; 3519 participants were controls. Overweight (BMI z-score ≥1) and pubertal status were not different among groups. According to the Basic Model, ADHD was significantly associated with RSS (OR 1.25, 95% CI 1.03-1.50), and even after adjustments for lifestyle factors and dietary intake (OR 1.28, 95% CI 1.03-1.58). Stimulant-treated ADHD adolescents had similar height z-scores and lifestyles as those not treated with stimulants. CONCLUSION: Attention-deficit hyperactivity disorder was associated with RSS. Height deficit may be intrinsic to ADHD or its pharmacotherapy, rather than a consequence of lifestyle alone. Further studies are needed to determine the causal relationship between ADHD and short stature.

Vaccine Coverage Associated With Ending a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Wave: A Retrospective Longitudinal Analysis.

BACKGROUND: Two SARS-CoV-2 waves in Israel ended while a substantial number of individuals remained unvaccinated or partially vaccinated. The indirect protective effect of the first BNT162b2 vaccination campaign in Israel was evaluated between 22 December 2020 and 18 May 2021. METHODS: The daily percentage of new polymerase chain reaction (PCR)-confirmed SARS-CoV-2 cases among unvaccinated individuals was analyzed for trends. Major shifts were identified using piecewise linear regression analysis. At these shifts, the percentage of naturally vaccinated (past SARS-CoV-2 cases) and the percentage of actively vaccinated (by inoculation) individuals were weighted and summed to determine the percentage of natural and active vaccination (NAV). RESULTS: A first decline among unvaccinated individuals occurred during a lockdown period, when the percentage of NAV was 8.16%. The major decline occurred after the end of the lockdown when the percentage of NAV reached 52.05%. SARS-CoV-2 cases ultimately declined among unvaccinated individuals when the percentage of NAV reached 63.55%. During the study period, the Alpha variant was prevalent and the use of nonpharmaceutical interventions, including social distancing, existed to varying degrees. CONCLUSIONS: The vaccination campaign played a major role in the decline of SARS-CoV-2 infection among unvaccinated individuals, leading to the end of the first 2021 SARS-CoV-2 wave (Alpha variant) in Israel. Infection in unvaccinated individuals stopped when two-thirds of the population were naturally or actively vaccinated. Any change in characteristics of the virus or the population can lead to a new outbreak.

Wastewater-derived organic contaminants in fresh produce: Dietary exposure and human health concerns.

Irrigation with reclaimed wastewater is a growing practice aimed at conserving freshwater sources, especially in arid and semiarid regions. Despite the apparent advantages to water management, the practice of irrigation with reclaimed wastewater exposes the agroenvironment to contaminants of emerging concern (CECs). In this report, we estimated the unintentional dietary exposure of the Israeli population (2808 participants) to CECs from consumption of produce irrigated with reclaimed wastewater using detailed dietary data obtained from a National Health and Nutrition Survey (Rav Mabat adults; 2014-2016). Human health risk analyses were conducted based on acceptable daily intake (ADI) and threshold of toxicological concern (TTC) approaches. The highest unintentional exposure to wastewater-borne CECs was found to occur through the consumption of leafy vegetables. All analyzed CECs exhibited hazard quotients <1 for the mean- and high-exposure scenarios, indicating no human health concerns. However, for the extreme exposure scenario, the anticonvulsant agents lamotrigine and carbamazepine, and the carbamazepine metabolite epoxide-carbamazepine exhibited the highest exposure levels of 29,100, 27,200, and 19,500 ng/person (70 kg) per day, respectively. These exposure levels exceeded the TTC of lamotrigine and the metabolite epoxide-carbamazepine, and the ADI of carbamazepine, resulting in hazard quotients of 2.8, 1.1, and 1.9, respectively. According to the extreme estimated scenario, consumption of produce irrigated with reclaimed wastewater (leafy vegetables in particular) may pose a threat to human health. Minimizing irrigation of leafy vegetables using reclaimed wastewater and/or improving the quality of the reclaimed wastewater using an advanced treatment would significantly reduce human dietary exposure to CECs.

Non-Dairy Animal Protein Consumption Is Positively Associated with Overweight and Obesity in Israeli Adolescents.

Protein consumption apparently plays a role in weight control. This cross-sectional study examined the association of protein consumption in Israeli adolescents with overweight/obesity. 7th−12th grade students participating in a national school-based survey (2015−2016) completed self-administered questionnaires, including a food frequency questionnaire, and height and weight measurements (n = 3443, 48% males, 15.2 ± 1.6 years). WHO growth standards served to define weight status. Intakes of total protein and protein source were calculated. Multivariable logistic regression analyses evaluated associations with overweight/obesity (BMI z-score ≥ 1), adjusting for possible covariates. Total protein intake (median (IQR)) was 62.5 (45.5, 85.7) g/d, accounting for 12.0 (10.5, 13.6) percent of daily energy. Of participants, 31.4% were overweight/obese. In multivariable models, overweight/obesity was positively associated with incremental increases of 10 g/d in total protein intake (OR = 1.07, 95% CI: 1.02−1.12, p < 0.01), total animal protein intake (OR = 1.05, 95% CI: 1.01−1.10, p = 0.026), and non-dairy animal protein intake (OR = 1.06, 95% CI: 1.01−1.11, p = 0.029). No associations were found with plant or dairy protein intake. These associations remained when protein intake was reported as a percentage of daily energy and when overweight and obesity were analyzed individually. High daily protein intakes, principally from non-dairy animal sources, were positively associated with overweight/obesity in adolescents. Additional studies are needed to establish causality of these findings.

Risk Factors for Multiple Infections with Salmonella, Shigella, and Campylobacter in Single Individuals Identified in Israel between 1999 and 2020: A Case-Case Control Study.

BACKGROUND: Salmonella, Shigella, and Campylobacter are highly prevalent among children. Reports on risk factors of patients infected with all three pathogens, not simultaneously, are scarce. OBJECTIVES: To identify risk factors for multiple infection with Salmonella, Shigella, and Campylobacter in the same child. METHODS: Using the Israel Sentinel Laboratory-Based Surveillance Network, we conducted a retrospective observational case-case-control study among children aged 0-9 years. A case was defined as a child infected with Salmonella, Shigella, and Campylobacter at different occasions between January 1999 and December 2020. A control was defined as a child infected with a single pathogen once, during the same period. Logistic regression models were applied to determine the association between multiple infections and demographic characteristics. RESULTS: We identified 109 cases (0.1%) infected with Salmonella, Shigella, and Campylobacter, and 86,511 controls (99.9%) infected with only one bacteria type. In a multivariable analysis, we showed that being Jewish (odds ratio [OR] 2.4, 95% confidence interval [95%CI] 1.3-4.4), having residency in Jerusalem (OR 3.2, 95%CI 1.3-7.7), or in the southern district (OR 3.7, 95%CI 1.5-8.8) were independent risk factors for multiple infection. CONCLUSIONS: Although very rare, non-simultaneous infection with multiple bacteria does occur in Israel. National and local authorities should promote programs to encourage proper hygiene practices, which are culture-adjusted.

Comparisons in polypharmacy over a decade in community-dwelling older adults-findings from Israel national health and nutrition surveys.

BACKGROUND: Polypharmacy increases with age and is associated with serious health and economic costs. This study reports changes over a decade in medication-use patterns and polypharmacy, in Israeli community-dwelling older adults aged ≥ 65 years. METHODS: Demographic and health data from two representative national health cross-sectional surveys - MABAT ZAHAV 1 (MZ1) in 2005-2006, and MZ2 in 2014-2015 were analyzed. Polypharmacy was defined as use of ≥ 5 medications. Risk factors for polypharmacy were estimated by multivariable logistic regression with adjusted odds ratios (aOR) and their 95% confidence intervals (CI). RESULTS: Self-reported data on medications taken were available for 1647 participants (91.5%) in MZ1, and for 833 participants (80.2%) in MZ2, 55% women, and about 20% aged ≥ 80, in both surveys. The prevalence of polypharmacy was significantly lower in MZ2 than in MZ1: 64.2% versus 56.3%, p = .0001; with an aOR (95%CI) of 0.64 (0.52, 0.80). The most commonly taken drugs were for hypertension (27.0%, 25.3%), dyslipidemia (9.7%, 12.4%) and anticoagulation (9.2%, 9.8%). For approximately 10% of drugs, indications were either unknown or incorrect. Polypharmacy was significantly associated with poor self-health assessment 2.47 (1.99, 3.06), ≥ 4 versus 1-3 chronic illnesses 6.36 (3.85, 10.50), and age ≥ 80 versus younger 1.72 (1.32, 2.24). Similar associations were observed with major polypharmacy of ≥ 8 medications. CONCLUSION: Polypharmacy, although reduced in the last decade, requires constant attention, especially concerning lack of knowledge of indications which leads to poor adherence and adverse side effects. Health-care teams should carry out regular medicine reconciliation in at-risk elderly patients.

Effectiveness of BNT162b2 Vaccine Booster against SARS-CoV-2 Infection and Breakthrough Complications, Israel.

We estimated vaccine effectiveness (VE) of the BNT162b2 (Pfizer-BioNTech, https://www.pfizer.com) booster dose against SARS-CoV-2 infection and reduction of complications (hospitalization, severe disease, and death) among breakthrough cases in persons in Israel >16 years of age for <20 weeks. VE estimates reached 96.8% (95% CI 96.0%-97.5%) for persons 16-59 years of age and 93.1% (95% CI 91.8%-94.2%) for persons >60 years of age on week 3. VE estimates remained at these levels for 8 weeks in the 16-59 age group and 11 weeks in those >60. A slow decline followed, becoming more pronounced in the last 2-3 weeks of evaluation. Estimates in the last week of evaluation were 77.6% (95% CI 68.4%-84.2%) and 61.3% (52.5%-68.4%) for persons 16-59 years and >60 years, respectively. The more pronounced VE decline coincided with rapid increase in Omicron variant activity. Rate reduction of breakthrough complications remained moderate to high throughout the evaluation.

The impact of SARS-CoV-2 on respiratory syndromic and sentinel surveillance in Israel, 2020: a new perspective on established systems.

BackgroundThe COVID-19 pandemic presented new challenges for the existing respiratory surveillance systems, and adaptations were implemented. Systematic assessment of the syndromic and sentinel surveillance platforms during the pandemic is essential for understanding the value of each platform in the context of an emerging pathogen with rapid global spread.AimWe aimed to evaluate systematically the performance of various respiratory syndromic surveillance platforms and the sentinel surveillance system in Israel from 1 January to 31 December 2020.MethodsWe compared the 2020 syndromic surveillance trends to those of the previous 3 years, using Poisson regression adjusted for overdispersion. To assess the performance of the sentinel clinic system as compared with the national SARS-CoV-2 repository, a cubic spline with 7 knots and 95% confidence intervals were applied to the sentinel network's weekly percentage of positive SARS-CoV-2 cases.ResultsSyndromic surveillance trends changed substantially during 2020, with a statistically significant reduction in the rates of visits to physicians and emergency departments to below previous years' levels. Morbidity patterns of the syndromic surveillance platforms were inconsistent with the progress of the pandemic, while the sentinel surveillance platform was found to reflect the national circulation of SARS-CoV-2 in the population.ConclusionOur findings reveal the robustness of the sentinel clinics platform for the surveillance of the main respiratory viruses during the pandemic and possibly beyond. The robustness of the sentinel clinics platform during 2020 supports its use in locations with insufficient resources for widespread testing of respiratory viruses.

Monitoring SARS-CoV-2 Activity with Sentinel Surveillance: Lessons Learned from the First Wave in Israel.

BACKGROUND: Guidelines for pandemic preparedness emphasize the role of sentinel and syndromic surveillance in monitoring pandemic spread. OBJECTIVES: To examine advantages and obstacles of utilizing a sentinel influenza surveillance system to monitor community severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) activity based on Israel's experience from mid-March to mid-May 2020. METHODS: Several modifications were applied to the influenza surveillance system. The clinical component relied mainly on pneumonia and upper respiratory infection (URI) consultations with primary care physicians as well as visits to emergency departments (ED) due to pneumonia. The virological data were based on nasopharyngeal swabs obtained from symptomatic patients who visited outpatient clinics. RESULTS: By week 12 of the pandemic, the crude and age-specific primary physician consultation rates due to URI and pneumonia declined below the expected level, reaching nadir that lasted from week 15 until week 20. Similarly, ED visits due to pneumonia were significantly lower than expected from weeks 14 and 15 to week 20. The virological surveillance started on week 13 with 6/253 of the swabs (2.3%) positive for SARS-CoV-2. There was a peak of 13/225 positive swabs on week 145.8%. During weeks 17-20, none of the swabs (47-97 per week) were positive for SARS-CoV-2. This trend was similar to national data. CONCLUSIONS: The virological component of the surveillance system showed the SARS-CoV-2 community spread, but had low sensitivity when virus activity was low. The clinical component, however, had no yield. Sentinel surveillance can assist in monitoring future novel pandemics and should be augmented in revised preparedness plans.

Outcomes of cardiac surgery in patients with end-stage renal disease: Insights from the Israel national registries.

BACKGROUND: End-stage renal disease (ESRD) has been shown to be associated with increased mortality in patients undergoing cardiac surgery. We aimed to compare the short- and mid-term mortality after cardiac surgery of patients with dialysis-dependent ESRD (DD-ESRD) to patients with normal renal function (NRF), using national registries: the ESRD registry, the adult cardiac surgery registry (ACSR), and the National Mortality Registry. METHODS: The study population comprised 8207 adult patients who underwent either isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR), isolated mitral valve replacement (MVR), or CABG + valve-related procedure, between January 2017 and April 2019. Data were retrospectively extracted and reported to the ACSR by the department of medical records of each medical center. RESULTS: One hundred and four DD-ESRD patients (mean age 63.2 ± 8.8 years, 83.7% males) were compared with 8103 NRF patients (mean age 64.9 ± 9.8 years, 77.6% males). Median follow-up for the total cohort was of 32.0 months (IQR; 25.0, 40.0). In DD-ESRD compared to NRF patients, 30-day mortality was higher (14.4% vs. 2.3%, respectively, p = 0.0001) and 4-year survival was significantly lower (44% ± 0.06 vs. 91% ± 0.04, respectively, p = 0.0001). Fifty-three percent of DD-ESRD 30-day mortality was caused by sepsis. Risk factors associated with reduced midterm survival included: DD-ESRD patients (HR = 4.7, 95% CI; 1.2-18.2), MVR procedure (HR = 1.5, 95% CI; 1.04-2.1) and combined CABG + valve-related procedure (HR = 1.6, 95% CI; 1.2-2.04). CONCLUSIONS: Preoperative DD-ESRD was associated with a significant increase in 30-day and mid-term mortality after cardiac surgery. The highest mortality rate was observed in valvular and combined procedures.

Milk and dairy consumption is positively associated with height in adolescents: results from the Israeli National Youth Health and Nutrition Survey.

PURPOSE: Milk consumption is associated with increased height primarily in early childhood. However, in adolescents, data are scarce with inconsistent results. Since height is a proxy for overall health and well-being, this study evaluated the association of dairy intake with height in adolescents. METHODS: Students in 7th-12th grades, participating in the 2015-2016 Israeli Health and Nutrition Youth Survey, a school-based cross-sectional study, completed self-administered questionnaires, including a semi-quantitative food frequency questionnaire (n = 3529, 48% males, 15.2 ± 1.6 years). Anthropometric measurements were also performed. Dairy servings were calculated as the calcium equivalent of 1 cup of milk, and consumption was divided into four categories from very low (< 1 serving/day) to high (3 + servings/day). BMI- and Height-for-age z scores (HAZs) were calculated according to WHO growth standard; relatively short stature (RSS) was defined as HAZ < - 0.7 SD (< 25th percentile). Multivariable linear and logistic regression analyses were performed to evaluate the association of dairy intake with HAZ and prevalence of RSS, respectively. RESULTS: Median consumption of dairy products was 2 servings/day, 1.4 from unsweetened products (milk, cheese and yogurt). Controlling for age, sex, BMI-z-score and socioeconomic status, each increment of unsweetened dairy intake was associated with on average 0.04 higher HAZ (equivalent to 0.3-0.4 cm, p < 0.05), and with reduced risk for RSS: OR 0.90, 95%CI: 0.84, 0.97, p < 0.01. No such associations were found with sweetened dairy products. CONCLUSION: Consumption of unsweetened dairy products (3-4 servings/day) appears to contribute to achieving growth potential in adolescents. Intervention studies are necessary to determine the causal relationship between dairy intake and linear growth.

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel.

BACKGROUND: Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance. METHODS: We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons. RESULTS: Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637. CONCLUSIONS: The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

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

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.

The BNT162b2 vaccine effectiveness against new COVID-19 cases and complications of breakthrough cases: A nation-wide retrospective longitudinal multiple cohort analysis using individualised data.

BACKGROUND: The rapid vaccination campaign against COVID-19 in Israel relied on the BNT162b2 vaccine. We performed a longitudinal analysis of multiple cohorts, using individual data, to evaluate the effectiveness of the vaccine against new and breakthrough cases. METHODS: We estimated vaccine effectiveness (VE) for 27 consecutive cohorts, each comprised of individuals vaccinated on specific days. VE against new COVID-19 cases was evaluated for five SARS-CoV-2-related outcomes: infection, symptomatic disease, hospitalisation, severe/critical disease and death. For breakthrough cases, rate reduction was evaluated for hospitalisation, severe/critical disease and death. Outcomes were evaluated at predetermined time-periods after vaccination, the last one dedicated to individuals who became SARS-CoV-2-positive 22-28 days after the second dose. FINDINGS: The highest VE estimates against new cases in ≥16 year old individuals, for all outcomes, were reached at the 15-21 day period after the second dose, ranging between 97.7% (95% CI: 95.9-98.7%) for deaths and 98.6% (95% CI: 97.8-99.1%) for severe/critical disease. VE estimates of the 14-20 day period after the first dose ranged between 54.3% (95% CI: 50.6-57.8%) for infection and 77.3% (95% CI: 71.2-82.1%) for severe/critical disease. VE rose more slowly among ≥80 year old individuals. Rate reductions of breakthrough complications were highest at the 22-28 day period after the second dose, ranging between 47.4% (95% CI: 4.3-71.2%) for death and 66.2% (95% CI: 44.2-79.6%) for severe/critical disease. INTERPRETATION: The BNT162 vaccine is highly effective in preventing new SARS-CoV-2 cases. Among ≥80 year old individuals, high effectiveness develops more slowly. In breakthrough cases, vaccination reduces complications and death. FUNDING: None.