The writer challenges the ethics of the “coronavirus vaccine campaign.” She states “we expect our young people to take a non-FDA approved biologic in pursuit of (the objective) … to benefit the older and sicker among us.” She implies that coronavirus vaccination to young people at low risk for severe symptoms is unwarranted and potentially harmful. She argues that insufficient attention is paid to the ethics of conducting research trials in children.
We address the following misunderstandings:
1. Proposed clinical trials of new drugs undergo rigorous scrutiny by professionally trained bioethicists, medical practitioners and research scientists during a mandatory Institutional Review Board process at each study site. Studies involving children receive additional scrutiny because of more stringent requirements for informed consent. Once clinical trials are underway, Data Safety Monitoring Boards continuously oversee safety, efficacy and adherence to ethical standards.
2. Although coronavirus vaccines don't have "FDA approval," they do have FDA Emergency Use Authorization (EUA) in adults. EUA is not a perfunctory sanctioning of the vaccines; investigators must adhere to the same scientific integrity and ethical standards as for FDA approval. These standards apply for studies in children.
3. The Pfizer and Moderna vaccines are currently authorized for individuals over 16 and 18 years, respectively. As of yesterday (March 23) Moderna began enrolling children between ages of 6 months and 12 years (following parental consent!) into a trial endorsed by the American Academy of Pediatrics. We are unaware of “planned experimental studies on newborns” as claimed by the writer. Her advice to take a “slow careful look” has long ago been adopted by professional medical ethicists and incorporated into the clinical trial approval process.
4. The CDC reports 273 young Americans (less than 18 years old) have died from coronavirus. Not a single death has been reported from administration of over 146 million doses of coronavirus vaccines to Americans. The ethics of NOT protecting young people from severe coronavirus symptoms, including death, is what should concern us, if vaccinations are proven efficacious and safe for this age group.
5. The comment that the vaccines “just ... seems to prevent severe symptoms” is an understatement. The Moderna and Pfizer vaccines dramatically reduce the incidence of COVID-19 infections and most importantly, they reduce adult deaths by 95%. The qualifier “seems to prevent” is incorrect; the benefits in adults are as clear as any scientific fact can be. These vaccines are the wonder drugs of this decade.