Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19.

In the development of new vaccines, many trials use age de-escalation: after establishing safety and efficacy in adult populations, progressively younger cohorts are enrolled and studied. Age de-escalation promotes many values. The responsibility to protect children from potential risks of experimental vaccines is significant, not only given increased risks of adverse effects but also because parents and medical professionals have a moral responsibility to protect children from harms associated with novel, uncertain interventions. Further, given that young children cannot provide informed consent, acceptable risks for research requiring proxy consent are lower than for adults making decisions for themselves. Although age de-escalation approaches are widely used in vaccine trials, including notably in the recent development of pediatric COVID-19 vaccines, ethicists have not addressed the benefits and risks of these approaches. Their benefits are largely assumed and unstated, while their potential risks are usually overlooked. There are no official ethics guidelines for the use of age de-escalation in clinical research. In this paper, we provide a systematic account of key moral factors to consider when employing age de-escalation. Analyzing pediatric COVID-19 vaccine development as our key case study, we clarify the benefits, risks, and trade-offs involved in age de-escalation approaches and call for the development of evidence-based best practice guidelines to identify when age de-escalation is likely to be an ethical strategy in vaccine development.

Visitor Guidelines in US Children's Hospitals During COVID-19.

OBJECTIVES: To examine visitor guidelines among children's hospitals in the United States in response to the coronavirus 2019 (COVID-19) pandemic. METHODS: A retrospective assessment of visitor guidelines in 239 children's hospitals in the United States. RESULTS: In this study, we present an analysis of 239 children's hospital visitor guidelines posted to hospitals' Web sites during 1 week in June 2020. Of the 239 hospitals, only 28 did not have posted guidelines for review. The guidelines were analyzed and grouped by how the guidelines were updated in response to COVID-19. Parental visitation was restricted to 1 parent in 116 of the posted guidelines (49%). There were no obvious similarities among guidelines associated with their geographical (eg, state or local) location. As of February 2021, 33 of 55 (60%) randomly selected hospitals had not changed their visitor policy since our initial review. CONCLUSIONS: The COVID-19 pandemic triggered changes in publicly reported visitor guidelines across the majority of children's hospitals. With our findings, we suggest wide variation in policies and practices in how guidelines were updated. More work is needed to understand how to optimize public safety and preserve family-centered care and parental authority in times of crisis.

The impact of the COVID-19 pandemic on children with autism spectrum disorders.

In the unprecedented disruption and social isolation of the COVID-19 pandemic, families around the world are faced with questions of how their children can thrive in these conditions. On top of the ubiquitous challenges for all children, this public health crisis imparts unique difficulties for children with special health needs. We identify children with Autism Spectrum Disorder (ASD) as being particularly vulnerable to negative impacts of the COVID-19 pandemic. In this paper, we examine why children with ASD are uniquely vulnerable, recommend strategies to mitigate these stressors for children with ASD and their parents, explore the potential challenges of reintegration into society as conditions improve, and examine the obligations of healthcare and community stakeholders to support these families.

Hospital Visitation Policies During the SARS-CoV-2 Pandemic.

A significant change for patients and families during SARs-CoV-2 has been the restriction of visitors for hospitalized patients. We analyzed SARs-CoV-2 hospital visitation policies and found widespread variation in both development and content. This variation has the potential to engender inequity in access. We propose guidance for hospital visitation policies for this pandemic to protect, respect, and support patients, visitors, clinicians, and communities.

Ethical decision-making for children with neuromuscular disorders in the COVID-19 crisis.

The sudden appearance and proliferation of coronavirus disease 2019 has forced societies and governmental authorities across the world to confront the possibility of resource constraints when critical care facilities are overwhelmed by the sheer numbers of grievously ill patients. As governments and health care systems develop and update policies and guidelines regarding the allocation of resources, patients and families affected by chronic disabilities, including many neuromuscular disorders that affect children and young adults, have become alarmed at the possibility that they may be determined to have less favorable prognoses due to their underlying diagnoses and thus be assigned to lower priority groups. It is important for health care workers, policymakers, and government officials to be aware that the long-term prognoses for children and young adults with neuromuscular disorders are often more promising than previously believed due to a better understanding of the natural history of these diseases, benefits of multidisciplinary supportive care, and novel molecular therapies that can dramatically improve the disease course. Although the realities of a global pandemic have the potential to require a shift from our usual, highly individualistic standards of care to crisis standards of care, shifting priorities should nonetheless be informed by good facts. Resource allocation guidelines with the potential to affect children and young adults with neuromuscular disorders should take into account the known trajectory of acute respiratory illness in this population and rely primarily on contemporary long-term outcome data.

Should Extremely Premature Babies Get Ventilators During the COVID-19 Crisis?

In a crisis, societal needs take precedence over a patient's best interests. Triage guidelines, however, differ on whether limited resources should focus on maximizing lives or life-years. Choosing between these two approaches has implications for neonatology. Neonatal units have ventilators, some adaptable for adults. This raises the question of whether, in crisis conditions, guidelines for treating extremely premature babies should be altered to free-up ventilators. Some adults who need ventilators will have a survival rate higher than some extremely premature babies. But surviving babies will likely live longer, maximizing life-years. Empiric evidence demonstrates that these babies can derive significant survival benefits from ventilation when compared to adults. When "triaging" or choosing between patients, justice demands fair guidelines. Premature babies do not deserve special consideration; they deserve equal consideration. Solidarity is crucial but must consider needs specific to patient populations and avoid biases against people with disabilities and extremely premature babies.

The Ethics of Creating a Resource Allocation Strategy During the COVID-19 Pandemic.

The coronavirus disease 2019 pandemic has affected nearly every aspect of medicine and raises numerous moral dilemmas for clinicians. Foremost of these quandaries is how to delineate and implement crisis standards of care and, specifically, how to consider how health care resources should be distributed in times of shortage. We review basic principles of disaster planning and resource stewardship with ethical relevance for this and future public health crises, explore the role of illness severity scoring systems and their limitations and potential contribution to health disparities, and consider the role for exceptionally resource-intensive interventions. We also review the philosophical and practical underpinnings of crisis standards of care and describe historical approaches to scarce resource allocation to offer analysis and guidance for pediatric clinicians. Particular attention is given to the impact on children of this endeavor. Although few children have required hospitalization for symptomatic infection, children nonetheless have the potential to be profoundly affected by the strain on the health care system imposed by the pandemic and should be considered prospectively in resource allocation frameworks.