BNT162b2 Vaccine-Associated Myo/Pericarditis in Adolescents: A Stratified Risk-Benefit Analysis.

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.

COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities.

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.

Youth ice hockey COVID-19 protocols and prevention of sport-related transmission.

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.

Identifying meaningful outcome measures for the intensive care unit.

Despite important progress in measuring the safety of health care delivery in a variety of health care settings, a comprehensive set of metrics for benchmarking is still lacking, especially for patient outcomes. Even in high-risk settings where similar procedures are performed daily, such as hospital intensive care units (ICUs), these measures largely do not exist. Yet we cannot compare safety or quality across institutions or regions, nor can we track whether safety is improving over time. To a large extent, ICU outcome measures deemed valid, important, and preventable by clinicians are unavailable, and abstracting clinical data from the medical record is excessively burdensome. Even if a set of outcomes garnered consensus, ensuring adequate risk adjustment to facilitate fair comparisons across institutions presents another challenge. This study reports on a consensus process to build 5 outcome measures for broad use to evaluate the quality of ICU care and inform quality improvement efforts.

Pegfilgrastim: a review of the pharmacoeconomics for chemotherapy-induced neutropenia.

For oncology patients, febrile neutropenia (FN) can be a serious and costly toxicity of chemotherapy, often forcing a reduction in chemotherapy dose intensity and/or duration. Several therapeutic agents are used to reduce the occurrence of neutropenic episodes: granulocyte colony-stimulating factors (G-CSFs) and granulocyte-macrophage colony-stimulating factors. Appropriate administration of colony-stimulating factors reduces the risk of FN episodes and the costs associated with FN treatment. In the USA, the two most commonly used G-CSFs are filgrastim and the longer-acting pegfilgrastim. This pharmacoeconomic review of pegfilgrastim briefly considers some of the early research of G-CSFs, then focuses on the most recent comparative studies of pegfilgrastim against the backdrop of forthcoming US patent expiration for both products. The authors conclude with commentary on the market for pegfilgrastim in light of the growing debate surrounding the optimal selection of patients, treatment costs and future alternatives for the use of these agents in chemotherapy.