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2.
Contemp Clin Trials Commun ; 33: 101108, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2263009
3.
J Med Ethics ; 2022 Dec 05.
Article in English | MEDLINE | ID: covidwho-2161962

ABSTRACT

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207-42 836 young adults aged 18-29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least 18.5 serious adverse events from mRNA vaccines, including 1.5-4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430-4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates.

4.
J Infect ; 85(6): 671-675, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2049514

ABSTRACT

OBJECTIVES: To expand upon an observational study published by the Centers for Disease Control (CDC) showing an association between school mask mandates and lower pediatric COVID-19 cases. We examine whether this association persists in a larger, nationally representative dataset over a longer period. METHOD: We replicated the CDC study and extended it to more districts and a longer period, employing seven times as much data. We examined the relationship between mask mandates and per-capita pediatric cases, using multiple regression to control for observed differences. RESULTS: We successfully replicated the original result using 565 counties; non-masking counties had around 30 additional daily cases per 100,000 children after two weeks of schools reopening. However, after nine weeks, cases per 100,000 were 18.3 in counties with mandates compared to 15.8 in those without them (p = 0.12). In a larger sample of 1832 counties, between weeks 2 and 9, cases per 100,000 fell by 38.2 and 37.9 in counties with and without mask requirements, respectively (p = 0.93). CONCLUSIONS: The association between school mask mandates and cases did not persist in the extended sample. Observational studies of interventions are prone to multiple biases and provide insufficient evidence for recommending mask mandates.


Subject(s)
COVID-19 , Child , Humans , Schools , Cohort Studies
5.
WMJ ; 121(1): 13-17, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1801352

ABSTRACT

PROBLEM CONSIDERED: K-12 schools have shown minimal spread of COVID-19 when mitigation measures are employed. This study sought to determine baseline asymptomatic COVID-19 rates in secondary schools as students returned to full-time in-person learning with universal masking in place and to evaluate the logistical obstacles of implementing surveillance testing. METHODS: An observational cohort study lasting 11 weeks during spring 2021 included 2,288 students and staff in Wood County, Wisconsin. SARS-CoV-2 nasal polymerase chain reaction testing was done on consenting students and staff to determine baseline disease burden. Teacher surveys collected data on student masking compliance and classroom distancing. Information about percent positivity, secondary transmission, quarantine and distancing policies, screening participation, costs, and volunteer hour requirements were obtained. Modified quarantine for fully masked in-classroom exposures was evaluated. RESULTS: Percent positivity averaged 3.0% (0%-16.2% weekly) among students and 1.72% (0%-6.9% weekly) among staff. Two cases of secondary transmission were suspected out of 163 individuals quarantined. An average of 15.6% of the school population consented to participate each week. Minimum classroom distance between students ranged from 2.7 to 5.5 feet. Student masking compliance was greater than 87%. The cost of the program was $106,400 and required approximately 300 volunteer hours. The modified quarantine policy, where students were allowed to continue to attend in-person school after exposure to a case of COVID-19 if the infected and exposed parties were masking, did not result in additional transmission. CONCLUSIONS: In the setting of relatively high student masking compliance and limited distance between students, weekly secondary school screening of students and staff in an area of high community disease spread was found to be low yield, costly, and burdensome for the school district. Surveillance participation was low. A modified quarantine policy was not associated with increased in-school transmission. School funding may be better spent on targeted testing or other school expenses, especially with increasing vaccination rates.


Subject(s)
COVID-19 , COVID-19/epidemiology , Humans , Quarantine , SARS-CoV-2 , Schools , Students
6.
Eur J Clin Invest ; 52(5): e13759, 2022 May.
Article in English | MEDLINE | ID: covidwho-1685285

ABSTRACT

BACKGROUND: Male patients ages 12-17 years have an elevated risk of mRNA vaccination-associated myo/pericarditis. A risk-benefit analysis of first and second doses of mRNA vaccination in adolescent boys by health status and history of SARS-CoV-2 infection has not been performed. METHODS: Using the Vaccine Adverse Event Reporting System (VAERS), we identified BNT162b2 [Pfizer-BioNTech] myo/pericarditis occurrence according to CDC criteria. Main outcomes were as follows: 1) post-vaccination myo/pericarditis crude incidence in adolescents aged 12-15 and 16-17; and 2) two risk-benefit analyses by age, sex, comorbidity, variant and history of infection. RESULTS: Cases of myo/pericarditis (n = 253) included 129 after dose 1 and 124 after dose 2; 86.9% were hospitalized. Incidence per million after dose two in male patients aged 12-15 and 16-17 was 162.2 and 93.0, respectively. Weighing post-vaccination myo/pericarditis against COVID-19 hospitalization during delta, our risk-benefit analysis suggests that among 12-17-year-olds, two-dose vaccination was uniformly favourable only in nonimmune girls with a comorbidity. In boys with prior infection and no comorbidities, even one dose carried more risk than benefit according to international estimates. In the setting of omicron, one dose may be protective in nonimmune children, but dose two does not appear to confer additional benefit at a population level. CONCLUSIONS: Our findings strongly support individualized paediatric COVID-19 vaccination strategies which weigh protection against severe disease vs. risks of vaccine-associated myo/pericarditis. Research is needed into the nature and implications of this adverse effect as well as immunization strategies which reduce harms in this overall low-risk cohort.


Subject(s)
COVID-19 , Pericarditis , Adolescent , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Child , Female , Humans , Male , Pericarditis/epidemiology , RNA, Messenger , SARS-CoV-2
7.
Pediatrics ; 149(12 Suppl 2)2022 02 01.
Article in English | MEDLINE | ID: covidwho-1503669

ABSTRACT

OBJECTIVES: With layered mitigation strategies, there are low rates of secondary transmission of severe acute respiratory syndrome coronavirus 2; therefore, quarantine after close-contact exposure to severe acute respiratory syndrome coronavirus 2 in the kindergarten through 12th grade (K-12) setting further disrupts in-person learning with uncertain benefit. We explored the impact of eliminating quarantine for students with mask-on-mask exposures to coronavirus disease 2019 (COVID-19) on associated secondary transmission in schools. METHODS: This observational study was conducted in a large K-12 public school district in Omaha, Nebraska (August 1, 2020, to March 15, 2021). We assessed primary and secondary COVID-19 infections in teachers and staff, frequency of quarantine for students and staff, and the impact of eliminating quarantine on secondary transmission in mask-on-mask exposure settings. RESULTS: A total of 18 632 and 19 604 students and 2855 staff attended in-person learning in the fall and spring semesters, respectively; 1856 primary infections were among students and staff. Despite 3947 student quarantines in the fall and 1689 student quarantines in the first 10 weeks of spring semester instruction, there were only 2 cases of secondary transmission. A local policy change removed quarantine requirements for students with mask-on-mask exposure to COVID-19. Required quarantines in the spring semester reduced by 41% per primary infection compared with the fall; no student who qualified to avoid quarantine developed a secondary infection. CONCLUSIONS: School-based COVID-19 transmission was exceptionally low in this large K-12 Nebraska school district. Elimination of student quarantine after masked exposure to COVID-19 within school was not associated with secondary transmission. Elimination of unnecessary quarantine elimination may help maximize in-person learning in the 2021-2022 school year.


Subject(s)
COVID-19/prevention & control , COVID-19/transmission , Masks , Quarantine/statistics & numerical data , Schools , Adolescent , Child , Child, Preschool , Humans , Nebraska
8.
Br J Sports Med ; 56(1): 29-34, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1367421

ABSTRACT

OBJECTIVES: This observational study evaluated the impact of return-to-play protocols to prevent transmission of SARS-CoV-2 in a youth ice hockey programme in Virginia Beach, Virginia. METHODS: Following an outbreak of SARS-CoV-2 in November 2020, a COVID-19 Response Team evaluated the epidemiological data to identify transmission dynamics and develop enhanced protocols to prevent transmission. During the subsequent 18-week study period, incident cases were investigated to identify the likely transmission source; testing, quarantine and isolation recommendations were provided to families in accordance with Centers for Disease Control and Prevention guidelines. RESULTS: Simple but stringent protocols were implemented among 148 youth ice hockey players ages 6-18. Players were required to arrive at the rink in full gear; locker rooms were closed, building entry was limited to one parent per player, and masks were required at all times except for players on the ice. Following implementation of the enhanced protocols, more than 500 practices and games were completed with at least 15 858 athlete-hours of exposure and no within-programme COVID-19 transmission was detected despite high community incidence and sporadic household exposures. CONCLUSION: This study suggests indoor youth sports can operate safely with appropriate protocols in place, even within communities of high COVID-19 transmission, even when athletes are not yet vaccinated or wearing masks during play. Transmission appears to be more likely in congested indoor areas involving adults than on the ice during play. Protocols should be developed in collaboration with programme participants. Strong collaboration in the interest of youth sports can motivate adoption of protocols which prevent within-team transmission.


Subject(s)
COVID-19 , Hockey , Youth Sports , Adolescent , Athletes , Child , Humans , SARS-CoV-2
9.
MMWR Morb Mortal Wkly Rep ; 70(4): 136-140, 2021 Jan 29.
Article in English | MEDLINE | ID: covidwho-1052555

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has disrupted in-person learning in the United States, with approximately one half of all students receiving online-only instruction since March 2020.* Discontinuation of in-person schooling can result in many hardships (1) and disproportionately affects families of lower socioeconomic status (2). Current evidence suggests that transmission of SARS-CoV-2, the virus that causes COVID-19, in kindergarten through grade 12 (K-12) schools might not significantly contribute to COVID-19 spread nationwide (3). During August 31-November 29, 2020, COVID-19 cases, spread, and compliance with mask use were investigated among 4,876 students and 654 staff members who participated in in-person learning in 17 K-12 schools in rural Wisconsin. School-attributable COVID-19 case rates were compared with rates in the surrounding community. School administration and public health officials provided information on COVID-19 cases within schools. During the study period, widespread community transmission was observed, with 7%-40% of COVID-19 tests having positive results. Masking was required for all students and staff members at all schools, and rate of reported student mask-wearing was high (>92%). COVID-19 case rates among students and staff members were lower (191 cases among 5,530 persons, or 3,453 cases per 100,000) than were those in the county overall (5,466 per 100,000). Among the 191 cases identified in students and staff members, one in 20 cases among students was linked to in-school transmission; no infections among staff members were found to have been acquired at school. These findings suggest that, with proper mitigation strategies, K-12 schools might be capable of opening for in-person learning with minimal in-school transmission of SARS-CoV-2.


Subject(s)
COVID-19/epidemiology , COVID-19/transmission , Schools/statistics & numerical data , Adolescent , Adult , COVID-19/prevention & control , Child , Child, Preschool , Cooperative Behavior , Humans , Masks/statistics & numerical data , Public Health/legislation & jurisprudence , Rural Population/statistics & numerical data , School Teachers/psychology , School Teachers/statistics & numerical data , Students/psychology , Students/statistics & numerical data , Surveys and Questionnaires , Wisconsin/epidemiology
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