Bioethicists highlight greater threshold for medical decisions for children

Denver Newsroom, Apr 28, 2022 / 17:24 pm

As Moderna asks the Food and Drug Administration to authorize its coronavirus vaccine for children under 6, the National Catholic Bioethics Center on Thursday updated its guidance on COVID-19 vaccine mandates to include children and vulnerable persons.

“The NCBC wishes to highlight the higher threshold of therapeutic benefit that must be applied to medical decisions for any persons at greater risk of exploitation, such as children,” the NCBC, a bioethics think tank, said in an April 28 statement announcing the update.

“We emphasize the importance of respecting the rightful role of parents or legal representatives in making medical decisions for minors or others incapable of giving their own consent. These decisions must be made on a case-by-case basis with careful weight given to all ethically relevant factors including the potential burdens and benefits,” the center said.

“The updated NCBC statement also recalls the higher ethical standards required in medical research, including the need for appreciable direct benefits to research participants themselves as distinct from benefits accruing solely to other people. Research data strongly suggests that children are the demographic group at lowest risk of harm from COVID-19. Parents and society have a particular duty to protect vulnerable children and others who cannot make their own medical decisions.”

With some calls for the requirement of COVID-19 vaccination for school children after FDA authorization is given, the bioethics center added that “Mandating COVID-19 immunization with the currently available vaccines in the absence of generous medical, conscience, and religious exemptions raises ethical concerns, especially when dealing with young populations.”

Among theses concerns, the NCBC said, are “the potential long-term risks of these new COVID-19 vaccines and limited vaccine follow-up data, and the unknown long-term risks of COVID-19 infection that take on greater weight for children who have a long timeline for living ahead of them.”

The NCBC is opposed to mandated immunization for COVID-19, while also acknowledging that reception of the coronavirus vaccines is morally permissible.

In a December 2020 note, the Congregation for the Doctrine of the Faith stated that “vaccination is not, as a rule, a moral obligation” and “therefore, it must be voluntary.” 

It said that the morality of vaccination depends on both the duty to pursue the common good and the duty to protect one’s own health, and that “in the absence of other means to stop or even prevent the epidemic, the common good may recommend vaccination.”

In its updated statement on coronavirus vaccine mandates, the NCBC highlighted that there are “additional considerations” warranted by such mandates “for persons incapable of giving their own fully informed consent, including children.”

“Parents or legal representatives have the right and responsibility to make medical decisions on behalf of persons in their charge who are unable to give proper informed consent as part of providing for their physical and spiritual needs,” the center said. 

“Their decisions to accept or decline COVID-19 vaccines for those in their care should result from free and informed consent and should be respected. COVID-19 vaccines should never be administered—and minors should never be induced to accept or demand vaccination—without the knowledge and consent of parents or legal representatives.”

The NCBC noted that “despite the completion of certain stages of the clinical research trials, much remains unknown about these novel COVID-19 biologics. They are the first genetic vaccines (i.e., that introduce genetic material which instructs the person’s cells to create viral antigens, rather than directly introducing the viral antigens) to be used in human populations on a large scale.”

It said that Phase 3 trials in adults “have not yet been concluded,” and “Phase 4 observational research regarding the safety and efficacy of the vaccines began in December 2020 and remains ongoing. Consequently, there is no robust data on the long-term consequences of the genetic vaccines.”

“From an ethical standpoint, the use of the COVID-19 vaccines remains subject to the ethical standards of medical research, which are higher than the standards applicable to thoroughly studied and well-understood medical interventions with firmly established and time-tested risk-benefit profiles.”

“The preeminent ethical requirement for any medical experimentation on persons incapable of giving their own consent is a compelling expectation of direct benefit to the person receiving the intervention,” the center stated.

“Indirectly protecting others, such as teachers, grandparents, caregivers, or immunocompromised persons, is not an ethically appropriate rationale for administering to a child or other person unable to consent a novel biologic with largely unknown long-term risks. Yet this other-focused risk reduction is one of the key reasons invoked in support of mandates for COVID-19 vaccines.”