COVID-19 vaccine trials with children: ethics pointers

Abstract

As healthcare authorities around the world strive to get as many citizens as possible vaccinated against the SAR-CoV-2 virus, many countries have begun including children in the population groups to be vaccinated. Properly designed clinical trials involving children are important to ensure safety, efficacy, and dosage of therapies in (developing) children. Within the complex health, social, and political scenario of the ongoing pandemic, ethics committees and policy makers in low-income and middle-income settings need to consider additional ethical questions when called on to review phase III COVID-19 vaccine trials involving in children. We set out some of the ethical questions to keep in mind before, during, and after the implementation of phase III COVID-19 vaccine trials in limited resource settings. Specifically, we discuss and offer succinct answers to the following questions: How relevant will the trial vaccine be for the population participating in the trial? Should vaccines that have not been approved for use among adults be approved for use in trials with children? Which children should be involved in COVID-19 vaccine trials? What criteria of informed consent are to be adopted with minors? Placebo versus an existing already approved vaccine? What specific duties of ancillary care should be taken into consideration for COVID-19 vaccines especially in low-income and middle-income countries? The answers we offer are considerations that can serve as ‘things to think about’ when reviewing or implementing COVID-19 trials involving children in low-income settings.

COVID-19 vaccine trials with children: the Jewish ethics

“…I hope and trust that awareness of this kind of religious backing will encourage participation in the critical COVID-19 medical research now in progress. Future studies should deal with other questions that were asked by Aturie et al 1. These studies may contribute to the conduct of ethically and medically worthy research on humans for the sake of humans.…”

“…Ethics in an emergency has to balance the obligation to find a solution for a problem quickly and the elimination of obstacles with the inherent danger of the dam bursting and the consequent flood of ethical problems in these solutions. However, as Aturie et al 1 noted, attention is not being directed toward these areas, and the protections against the dangers in some clinical trials for the treatment of COVID-19 collapse. I have presented arguments as to how one must behave ethically both in terms of administering an experimental drug and volunteering to take part in a clinical trial.…”

“…I read with great interest the article of Atuire et al 1. The article presented the ethical challenges of conducting a paediatric vaccine trial against COVID-19.…”

COVID‐19 vaccination in children as a global dilemma through an ethical lens: A retrospective review

“…Hence, we should have enough knowledge about the safety of each vaccine in various developmental stages, with the aim of not disturbing their growth, development and well‐being. 31 Some authorities even believe that there is no need to vaccinate children as most of them have already gotten the natural infection. Others believe that COVID‐19 vaccination is futile, and SARS‐CoV‐2 vaccines not only do not have the ability to prevent the disease, but also delay its onset with the vaccine's waning immunity; moreover, it is hypothesized that SARS‐CoV‐2 vaccination might lead to the emergence of immune escape mutations.…”

“…On the other hand, children are the population with a possibly long life‐expectancy and an efficient future ahead; although short‐term safety of SARS‐CoV‐2 vaccines has been justified as nonserious in children 5–11 years of age, 9,30 long‐term complications are not yet revealed and may weigh out the adverse effects of lockdown. Hence, we should have enough knowledge about the safety of each vaccine in various developmental stages, with the aim of not disturbing their growth, development and well‐being 31 . Some authorities even believe that there is no need to vaccinate children as most of them have already gotten the natural infection.…”