I read with interest the guest commentary titled “Pope is right; vaccination is ‘ethical choice’” (Catholic Virginian, Feb. 22), but I found no discussion of ”ethics.”
Medical ethics (Health Care Anal, 2017 September; 25(3):275- 289) includes the principles of autonomy, beneficence, non-maleficence and justice, and should guide the informed consent prior to any medical intervention.
Autonomy is an individual’s full control (consent) over their person and requires complete and accurate information about the intervention.
Beneficence is a discussion of the potential benefits from the intervention, the credibility of the information, and the potential consequences of non-intervention.
Non-maleficence is an accurate discussion of the potential complications that might be associated with the intervention, and justice requires that the information and the intervention be equally available regardless of ethnic or economic distinctions. Informed consent prior to medical interventions is required by most state legal codes.
Ethical informed consent that respects autonomy cannot be obtained from uninformed, misinformed or coerced patients. Approval by the FDA of a drug or device is typically an important basis for ethical consent.
The currently available COVID vaccines have not been granted full approval by the FDA but instead were granted approval for emergency utilization. Studies of long-term safety have not been completed.
Data, including lethal and non-lethal short- and long-term complications of these vaccines, are now being collected, making this emergency utilization investigational (experimental).
The expected benefit (beneficence) of vaccines is assumed to be the prevention of a serious illness. In the case of COVID, however, the initial statistical models predicting millions of deaths in the U.S. have been withdrawn as invalid.
Currently reported COVID overall mortality appears comparable to seasonal flu, and for those under 20 years of age, it is not zero but very low. The elderly and those with co-morbidities (diabetes, hypertension, obesity, immune compromise) have a higher risk that might impact their decision.
Moreover, no reliable information is yet available for the actual prevention of disease in vaccinated patients later exposed to the virus, and the duration of protection from the m-RNA vaccines is unknown.
Potential complications (maleficence) of vaccination include short- and long-term side effects, local at the injection site and systemic. These may include allergic reactions or the potential for hyper immune response following the exposure to the native virus after vaccination. The exact risks among large populations are unknown.
Deaths and miscarriages have been reported following vaccination, but it is difficult to ascribe causation with incomplete data. Anaphylactic reactions (severe systemic allergic reactions) are a known risk of all vaccinations.
The use in pregnancy before full assessment of risks is a concern. The use of aborted fetal cell lines in the development, testing or production of all three available vaccines is a moral concern for many (USCCB, March 2, 2021) and should also be included in informed consent.
Justice requires the availability of the vaccines and complete information equally to all eligible recipients regardless of economic or ethnic distinctions.
The use of the currently available COVID vaccines can be an ethical choice if fully informed consent, as described, is provided prior to the injection. However, ethical choices may not necessarily always be wise or moral choices.
Dr. Seeds is emeritus professor of Obstetrics and Gynecology and Maternal and Fetal Medicine at Virginia Commonwealth University, and a member of St. Benedict Parish, Richmond.