The case against COVID-19 vaccine mandates in pediatric solid organ transplantation.

BACKGROUND: The American Society of Transplantation in conjunction with the International Society for Heart and Lung Transplantation released a joint statement on August 13, 2021 in which they strongly recommend that solid organ transplant (SOT) recipients and their eligible household members and close contacts be vaccinated against SARS-CoV-2 with an approved COVID-19 vaccine. Some SOT programs have gone further and will refuse to list or transplant candidates unless the candidate and their household are vaccinated against SARS-CoV-2. METHODS: Two general pediatrician-ethicists use current best evidence and moral theory to argue why it is unethical to mandate COVID-19 vaccination for pediatric SOT candidates, their primary support person, and their households. RESULTS: Pediatric vaccine mandates are most justifiable when they prevent the harm of a serious vaccine preventable disease (VPD) in children in settings where transmission is highly likely and there are no alternatives that are effective in preventing transmission that intrude less on individual freedom. An additional justification for a vaccine mandate in the SOT context is stewardship of a scarce resource if there is significant risk of graft loss from the VPD to an unvaccinated SOT candidate or recipient. Current evidence does not support fulfillment of these criteria in pediatric solid organ transplantation. CONCLUSIONS: Making SOT listing contingent on COVID-19 vaccination is problematic. Though there is some risk of harm to a pediatric SOT candidate in remaining unvaccinated, the risk of harm of not being listed and transplanted is greater and overriding.

Analyzing Trends in the Global Surge of Coronavirus Disease 2019 Pandemic Submissions to The Journal of Pediatrics.

During February to December 2020, there were 498 coronavirus disease 2019 (COVID-19) pandemic-focused brief report and original article submissions to The Journal of Pediatrics. The majority were from international authors (68.1%). Early in the pandemic, geographic origin of the corresponding author paralleled the path of COVID-19 infection both within the US and around the globe.

SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges.

As the nation implements SARS-CoV-2 vaccination in adults at an unprecedented scale, it is now essential to focus on the prospect of SARS-CoV-2 vaccinations in pediatric populations. To date, no children younger than 12 years have been enrolled in clinical trials. Key challenges and knowledge gaps that must be addressed include (1) rationale for vaccines in children, (2) possible effects of immune maturation during childhood, (3) ethical concerns, (4) unique needs of children with developmental disorders and chronic conditions, (5) health inequities, and (6) vaccine hesitancy. Because COVID-19 is minimally symptomatic in the vast majority of children, a higher acceptable risk threshold is required when evaluating pediatric clinical trials. Profound differences in innate and adaptive immunity during childhood and adolescence are known to affect vaccine responsiveness for a variety of childhood diseases. COVID-19 and the accompanying social disruption, such as the school shutdowns, has been disproportionately damaging to minority and low-income children. In this commentary, we briefly address each of these key issues, specify research gaps, and suggest a broader learning health system approach to accelerate testing and clinical trial development for an ethical and effective strategy to implement a pediatric SARS-CoV-2 vaccine as rapidly and safely as possible. IMPACT: As the US begins an unprecedented implementation of SARS-CoV-2 vaccination, substantial knowledge gaps have yet to be addressed regarding vaccinations in the pediatric population. Maturational changes in the immune system during childhood have influenced the effectiveness of pediatric vaccines for other diseases and conditions, and could affect SARS-CoV-2 vaccine responsiveness in children. Given that COVID-19 disease is far milder in the majority of children than in adults, the risk-benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed. The needs of children with developmental disabilities and with chronic disease must be addressed. Minority and low-income children have been disproportionately adversely affected by the COVID-19 pandemic; care must be taken to address issues of health equity regarding pediatric SARS-CoV-2 vaccine trials and allocation. Research and strategies to address general vaccine hesitancy in communities must be addressed in the context of pediatric SARS-CoV-2 vaccines.

Impact of the Coronavirus Disease 2019 Pandemic on Authorship Gender in The Journal of Pediatrics: Disproportionate Productivity by International Male Researchers.

OBJECTIVE: To assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on authorship gender in articles submitted to The Journal of Pediatrics. STUDY DESIGN: Using gender-labeling algorithms and human inspection, we inferred the gender of corresponding authors of original articles submitted in January-February and April-May of 2019 and 2020 noting those articles related to the COVID-19 pandemic. We used Pearson χ2 tests to determine differences in gender proportions during the selected periods in the US and internationally. RESULTS: We analyzed 1521 original articles. Submissions increased 10.9% from January-February 2019 to January-February 2020 and 61.6% from April-May 2019 to April-May 2020. Women accounted for 56.0% of original articles in April-May 2019 but only 49.8% of original articles in April-May 2020. Original articles focused on COVID-19 represented a small percentage of additional articles submitted in January-February 2020 (1/33 or 3.0%) and (53/199 or 26.6%) in April-May 2020 compared with the number of submissions in the same months in 2019. International male corresponding authors submitted a significantly larger proportion of original articles compared with international female corresponding authors in April-May 2020 compared to April-May 2019 (P = .043). There was no difference in corresponding author gender proportion in the US (US in April-May of 2020 vs April-May of 2019; P = .95). There was no significant difference in final dispositions based on corresponding author gender for original articles from 2019 and 2020 (P = .17). CONCLUSIONS: Original article submissions to The Journal increased in April-May 2020, with the greatest increase by international male corresponding authors. The majority of the submission growth was not related to COVID-19.

Reopening K-12 Schools in the Era of Coronavirus Disease 2019: Review of State-Level Guidance Addressing Equity Concerns.

OBJECTIVE: To determine how state guidance documents address equity concerns in K-12 schools during the coronavirus disease 2019 pandemic. STUDY DESIGN: Using online searches, we collected state-level documents from all 50 states and the District of Columbia discussing reopening plans for K-12 schools in the 2020-2021 academic year. We examined whether these documents explicitly mentioned equity as a concern, as well as if and how they addressed the following equity issues: food insecurity and child nutrition, homelessness or temporary housing, lack of access to Internet/technology, students with disabilities or special needs, English-language learners, students involved with or on the verge of involvement with the Department of Children and Family Services or an equivalent agency, mental health support, students/staff at greater risk of severe illness from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and students/staff living with someone at greater risk of severe illness from SARS-CoV-2 infection. RESULTS: Forty-four of 51 states (86%) explicitly mentioned equity as a concern or guiding principle. At least 90% of states offered guidance for 7 equity issues. Fewer than 75% of states addressed homelessness or temporary housing, students involved with or on the verge of involvement with Department of Children and Family Services or an equivalent agency, and students/staff living with someone at greater risk of severe illness from SARS-CoV-2 infection. CONCLUSIONS: Wide variability exists in state-level guidance to help K-12 schools develop reopening plans that protect those who are most vulnerable to learning loss or reduced access to basic needs. Interpretation and implementation by local educational agencies will need to be assessed.