Strategy for Administering Vaccines against COVID 19 that received Emergency Use Authorization
The First - Pfizer Biontech vaccine received EUA on Dec 11 20.
The second - Moderna Vaccine is expected to receive EUA on 12 19 20
Before we propose to answer this question on the Ethical aspects of the strategic placement of the Vaccine in the bodies of millions of individuals including and especially the residents of Long-Term Facilities we need to understand what Emergency Use Authorization and what steps is have been taken already for Post Authorization
Are the proposed decisions to Vaccinate against COVID -19 to protect the lives of residents of Long-Term Care Facilities actions likely to adversely affect the lives of millions of our fellow Americans conform to these standards imposed on all Physicians and Researchers, namely the Double effect Reasoning or Doctrine Effects [DBE] and the CODE of MEDICAL ETHICS including the Principle of Primum Non Nocere that has endured for over 2000 years- Latin for ‘first do no harm.’ A guiding principle for physicians that, whatever the intervention or procedure, the patient’s well-being is the primary consideration and the Double Effect Reasoning, Doctrine of Double Effects.
Emergency Use Authorization for Vaccines Explained
FDA is globally respected for its scientific standards of vaccine safety, effectiveness, and quality. The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.
FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.
Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program.
The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period.
Some of these systems are the
- Vaccine Adverse Event Reporting System (VAERS),
- the Vaccine Safety Datalink (VSD),
- the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.
How will Vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.
The FDA also provides the following Data critical to the successful introduction of two Vaccines into individuals at work in high-risk environment to save lives and to protect the health and wellbeing of the residents of Long-term facilities especially those who have multiple levels of disabilities and several medical co-occurring disorders that placed them at high risk for severe manifestations of COVID -19.
- Fact Sheet for Healthcare Providers Administering Vaccine
- Fact Sheet for Recipients and Caregivers [Vaccine Information Sheet. This VIS can be instrumental in assuring the resident can form an informed decision to affirm consent without coercion to receive the vaccine or withhold consent autonomously]
Part II: Human Rights and Medical Ethics
The Doctrine of Double Effects consists of four conditions that must be satisfied before an act is morally permissible:
1. The nature-of-the-act condition. The action must be either morally good or indifferent.
2. The means-end condition. The bad effect must not be the means by which one achieves the good effect.
3. The right-intention condition. The intention must be the achieving of only the good effect, with the bad effect being only an unintended side effect.
4. The “proportionality” condition. The good effect must be at least equivalent in importance to the bad effect.
The second of these four conditions are an application of the more general principle that good ends do not justify evil means (cf. Romans 3:8). [I have written extensively on these concerns my patients and colleagues have about the frenzy of hyperbolic rhetoric that is sadly driving the Legislative process that driving terror into the hearts of millions.VM]
Code of Medical Ethics
There are 4 principles that constitute the Code of Medical Ethics for a good measure to protect the individual persons right to self-determination in a collaborative decision- making process and thus assert both their right to receive treatment that is indicated for their overall health and welfare and the right as well to refuse treatment with loss of any of the treatments that are now being received and may be necessary to be considered in the future course of their treatment.
- Justice 2. Beneficence 3. Autonomy 4. Non- Maleficence [ More on this follows Page 4 and 5]
The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission, created as a result of the National Research Act of 1974, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles. Informed by monthly discussions that spanned nearly four years and an intensive four days of deliberation in 1976, the Commission published the Belmont Report, which identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.
Applications for comprehensive ethical principles in research involving human participants is informed by the Belmont Report. This is appropriate to do at this stage of development of the Vaccine approved under the terms of the EUA to ensure a safe and successful introduction of a previously unapproved agent into Humans to protect them from perilous risks and all too often Fatal outcomes among residents of Long-Term Facilities. At this stage of the pandemic, it tragically well over 100,000 residents of Long-term Care facilities.
The most important step in individualizing the Success and safety of the National Vaccination Strategy to save the lives of millions of individuals who have been approved as the first recipients of either of two Vaccines- namely 1. PfizerBionTech or 2. Moderna is to provide for instance the FDA approved Vaccination Information Sheet- VIS, answer questions, discuss concerns while seeking to obtain INFORMED CONSENT of the prospective recipient of the Vaccine.
A critical component of respecting the individuality and autonomy of human participants is the Informed Consent process. The Consent document is a written summary of the information that should be provided to the participant.[The VIS created by the FDA is an essential component of the information package]. Many investigators use it as a guide for the verbal explanation of the study. The participant's signature on the form shows agreement to participate in a study, but that is only one part of the consent process. The entire informed consent process involves: [Providing Information- being transparent, material at the level of comprehension of the recipients]
1) giving a participant adequate information about the study, [In this instance the National Vaccination Program]
2) providing adequate opportunity for the participant to consider all options, responding to the participant's questions,
3) ensuring that the participant has comprehended this information,
4) obtaining the participant's voluntary agreement to participate, and
5) continuing to provide information as the participant or situation requires.
The FDA and the Manufacturer have plans to go forward to keep close track of the effects of the Vaccine and have provided for feedback to be sent to the FDA [Please see Page 3]
In the case of subjects whose ability to understand might be limited, i.e., children, mentally disabled patients or those who are very ill, special provision may have to be made.
With these groups, often permission must be sought from a third party who would be able to understand the incompetent participant’s situation and act in their best interest. This third person should be able to follow the research and be able to withdraw the participant if it appears to be in the best interest for the individual. [See Item 5 page3 above]
Informed Consent is built on autonomous efforts of the individual or appropriate legally authorized persons to determine to affirm the consent to receive either Vaccine or withhold consent from receiving both.
Assessment of Risks and Benefits
Assessing risks and benefits means the researcher[or in this case the HC provider] needs to assemble all data that explains why the research [the Vaccine and the Vaccination program] will obtain the benefits that are sought by the research project [Conferring Immunity from COVID -19}. The review committee of the researcher’s sponsoring institution,[ in this instance-the committees of the FDA] upon review of the collected data, can decide whether the risks to the subjects are justified.[ and permit the Vaccination program to be continued]. The goal is to assist the prospective participant [recipient of the Vaccine] can determine whether to participate.[in the National Vaccination Program and receive one or other vaccine]
The term “risk” refers to the possibility that harm might occur.
There are many kinds of risks, such as:
physical, [including loss of life or limb]
The term “benefit” in the research context [and in this Vaccination Program] refers to something positive as related to health or welfare.
Risk and benefits affect not only individual participants, but also their families and society at large. Importantly, in the past regulations about human subjects, the risk to participants has been outweighed by the sum of both the anticipated benefit to participants, and the anticipated benefit to society in the form of new knowledge to be gained by the research.
The principle of Justice—that benefits, and risks of research be distributed fairly. [One of the key principles of Medical Ethics, Page 3] Researchers are not being just if they only select disadvantaged persons for risky research or only provide beneficial research to groups they favor.
Special classes of Injustice arise when participants are drawn from vulnerable populations those institutionalized or incarcerated in prisons, racial minorities, economically disadvantaged or the very sick. [With respect this type of Institutionalized injustice has been eliminated because persons constituting disadvantaged communities are being included as high priority recipients of one of the two Vaccines to protect their health and saves their lives.VM]
Key elements of the Belmont Report
Padma Nambisan, in An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology, 2017
The Belmont Report prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is a statement of basic ethical principles and guidelines that provide an analytical framework to guide the resolution of ethical problems that arise from research with human subjects. The basic ethical principles delineated in the report include:
Respect for Persons
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to protection
- Human participants should not be harmed
- Research should maximize possible benefits and minimize possible risks
- The benefits and risks of research must be distributed fairly
- Volunteer research participants, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them
- The consent process must include three elements:
- Comprehension, and
- Voluntary participation
- Assessment of risks and benefits - The nature and scope of risks and benefits must be assessed in a systematic way
Values in Medical Ethics:
A common framework used in the analysis of medical ethics is the "four principles" approach postulated by Tom Beauchamp and James Childress in their textbook “Principles of biomedical ethics.”
It recognizes four basic moral principles, which are to be judged and weighed against each other, with attention given to the scope of their application.
The four principles are:
Respect for autonomy - the patient has the right to refuse or choose their treatment. (Voluntas aegroti suprema lex.)
Beneficence a practitioner should act in the best interest of the patient. (Salus aegroti suprema lex.)
Non-maleficence - "first, do no harm" (Primum Non Nocere).
Justice - concerns the distribution of scarce health resources, and the decision of who gets what treatment (Fairness and Equality).
Other values that are sometimes discussed include:
Respect for persons - the patient (and the person treating the patient) have the right to be treated with dignity.
Truthfulness and honesty - the concept of informed consent has increased in importance since the historical events of the Doctors' Trial of the Nuremberg trials and Tuskegee syphilis experiment. Values such as these do not give answers as to how to handle a particular situation but provide a useful framework for understanding conflicts.
When moral values are in conflict, the result may be an ethical dilemma or crisis. Sometimes, no good solution to a dilemma in medical ethics exists, and, on occasion, the values of the medical community (i.e., the hospital and its staff) conflict with the values of the individual patient, family, or larger non-medical community.
Conflicts can also arise between health care providers, or among family members. Some argue for example, that the principles of autonomy and beneficence clash when patients refuse blood transfusions, considering them life-saving; and truth-telling was not emphasized to a large extent before the HIV era.