Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design.

IMPORTANCE: The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults. OBSERVATIONS: We describe the protocol for the Pediatric Observational Cohort Study of the NIH's REsearching COVID to Enhance Recovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of four cohorts that comprise RECOVER-Pediatrics: 1) a de novo RECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study (n = 10,000). The de novo cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n = 6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n = 6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n = 600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science. CONCLUSIONS AND RELEVANCE: RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions. CLINICAL TRIALS.GOV IDENTIFIER: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Real-World Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents.

BACKGROUND: The efficacy of the BNT162b2 vaccine in pediatrics was assessed by randomized trials before the Omicron variant's emergence. The long-term durability of vaccine protection in this population during the Omicron period remains limited. OBJECTIVE: To assess the effectiveness of BNT162b2 in preventing infection and severe diseases with various strains of the SARS-CoV-2 virus in previously uninfected children and adolescents. DESIGN: Comparative effectiveness research accounting for underreported vaccination in 3 study cohorts: adolescents (12 to 20 years) during the Delta phase and children (5 to 11 years) and adolescents (12 to 20 years) during the Omicron phase. SETTING: A national collaboration of pediatric health systems (PEDSnet). PARTICIPANTS: 77 392 adolescents (45 007 vaccinated) during the Delta phase and 111 539 children (50 398 vaccinated) and 56 080 adolescents (21 180 vaccinated) during the Omicron phase. INTERVENTION: First dose of the BNT162b2 vaccine versus no receipt of COVID-19 vaccine. MEASUREMENTS: Outcomes of interest include documented infection, COVID-19 illness severity, admission to an intensive care unit (ICU), and cardiac complications. The effectiveness was reported as (1-relative risk)*100, with confounders balanced via propensity score stratification. RESULTS: During the Delta period, the estimated effectiveness of the BNT162b2 vaccine was 98.4% (95% CI, 98.1% to 98.7%) against documented infection among adolescents, with no statistically significant waning after receipt of the first dose. An analysis of cardiac complications did not suggest a statistically significant difference between vaccinated and unvaccinated groups. During the Omicron period, the effectiveness against documented infection among children was estimated to be 74.3% (CI, 72.2% to 76.2%). Higher levels of effectiveness were seen against moderate or severe COVID-19 (75.5% [CI, 69.0% to 81.0%]) and ICU admission with COVID-19 (84.9% [CI, 64.8% to 93.5%]). Among adolescents, the effectiveness against documented Omicron infection was 85.5% (CI, 83.8% to 87.1%), with 84.8% (CI, 77.3% to 89.9%) against moderate or severe COVID-19, and 91.5% (CI, 69.5% to 97.6%) against ICU admission with COVID-19. The effectiveness of the BNT162b2 vaccine against the Omicron variant declined 4 months after the first dose and then stabilized. The analysis showed a lower risk for cardiac complications in the vaccinated group during the Omicron variant period. LIMITATION: Observational study design and potentially undocumented infection. CONCLUSION: This study suggests that BNT162b2 was effective for various COVID-19-related outcomes in children and adolescents during the Delta and Omicron periods, and there is some evidence of waning effectiveness over time. PRIMARY FUNDING SOURCE: National Institutes of Health.

Assessing the long-term health impact of COVID-19: The importance of using self-reported health measures.

It is estimated that at least one out of 10 people who contracted COVID-19 continue to experience health problems long after the clearance of the acute infection. These belong to the growing group of people who have post-acute sequelae of SARS CoV-2 infection or long COVID, a multifaceted condition involving multiple organ systems. Given the lack of clear definition and diagnosis, this marked increase in the number of people who have long COVID might not be fully reflected in data on population health in the years to come. In this editorial, we argue that the use of self-reported health measures is vital for fully assessing the long-term impact of the COVID-19 pandemic on health and health inequalities. After briefly introducing self-reported health measures, we discuss strengths and limitations of specific measures that capture direct self-reports of long COVID. We then outline how the impact of long COVID may also be reflected in response patterns to more general self-reported health measures and give suggestions on how these can be used to examine the long-term health impact of the COVID-19 pandemic.

An Exploratory Investigation of Government Air Monitoring Data after Hurricane Harvey.

Southeast Texas is home to some of the largest refineries in the United States. During Hurricane Harvey, emergency shutdowns took place. In this exploratory investigation, we examine how government air monitors performed in measuring air quality in Beaumont, Texas during and in the months following Hurricane Harvey. Texas Commission on Environmental Quality (TCEQ) data from two active air monitors in Beaumont, Texas were analyzed during the year 2017-2018. Concentrations of sulfur dioxide (SO2), nitric oxide (NO), oxides of nitrogen (NOx), ozone, benzene, and hydrogen sulfide (H2S) were investigated. The number of hours and days no data were reported by air monitors were also investigated. Yearly maximum values (MAX, all in parts per billion (ppb)) in 2017 for SO2, NO, and NOx (53.7, 113.4, 134, respectively) and their respective standard deviations (SD: 1.3, 3.4, and 14) were higher as compared to 2018 (MAX, all in ppb and (SD) = 40.9, (1.4); 103.9, (3.3); 123.8, (14), respectively). The data capture rate for these chemicals were between 88 and 97% in both years. During the months following Hurricane Harvey (August-December 2017) there was an increase in most maximum values. The yearly averages for H2S were 0.68 ppb (SD 1.02) in 2017 and 0.53 ppb (SD 1.07) in 2018. Missing days were observed for both the H2S and NOx air monitors, with the highest number observed in 2017 (213 missing days) for the air monitor measuring H2S. We identified that residents of Beaumont, Texas are exposed daily to low-level concentrations of air pollutants. H2S is released each day at a level high enough to be smelled. Data capture rates for air monitors are not always above 90%. Improved air quality data and disaster preparations are needed in Beaumont, Texas.