Q) Discuss the various ethical issues and interests of the various stakeholders involved in the development of a vaccine and its restricted emergency use. Should a vaccine be given to a patient without completion of the trials, even if initial data indicates it to be safe? (20 marks, 300 Words)
Source: The Hindu Editorial: A hurried gamble, An anti-disclosure amendment that hits public health.
Recently, Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd were granted by the Controller General of India(DCGI). The regulators have to weigh the interests of various stakeholders before granting such a permission.
Various stakeholders invoved include:
- Public to be vaccinated: A faulty vaccine or a faulty vaccination drive can be a cause of serious worry. For example, due to a loopholes in the vaccination drive of the poliovirus, a Vaccine derived Polio virus(VDPV) has born. All these issues must be identified and addressed at the trial stage itself.
- Participants in the trials: Often vaccines trigger severe "anaphylactic shock" which is a severe allergic reaction. Shock is when your blood pressure drops so low that your cells (and organs) don't get enough oxygen. Thus they are the first one in the line of defence.
- Vaccine developers: The companies and the institutions invoved in development of the vaccine are very important stakeholders. They work for the profit.
- Doctors/Nursing Staff: Medical staff is a very important stakeholder.
a. It is because handling of the vaccine too poses certain risks. This is because sometimes it contains live virus (attuned).
b. Whole responsibility of vaccination finally lies on the shoulders of the Medical staff. They face the public during vaccination drives.
- Regulator: Central Drugs Standard Control Organisation(CDSCO) which is the National Regulatory Authority (NRA) of India, and is It is headed by Drug Controller General of India(DCGI). In India Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered.
- Government and its departments:
? Central government generally takes the responsibility of the nationwide immunization in the country, as it is the case in Indradhanush mission for example
? State government: Health is primarily a state subject. Thus it has greater responsibility of storage and distribution of vaccines.
? Local governments: They too are constitutionally mandated to run primary healthcare facilities, which play a keystone role in vaccination drives.
- International Organizations/Other countries: Drug and Vaccine development is not only confined to the national level, but also affects everyone. This is because if attuned virus spreads from the lab, the world would be affected. Even the Coronavirus spread because in the initial days China was not transparent.
Ethical Issues invoved in development of the vaccine or allowing its emergency use:
- Right to be informed: the public has to be informed that a product has only been granted an EUA and not full approval. In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine.
- National interest of Indegenization: In order to produce a vaccine indegenously, we might breed a tendency to overlook the short comings of the domestic vaccine candidates. Further, it is unethical to wait for a domestic vaccine if a vaccine is available by other developers.
- Ethical issue of administering a placebo: in the trial It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere. The person who have received a placebo may roam around with the confidence of being vaccined and hurt the interest of himself as well as the society.
- Economic v/s Medical interests: The overall interest of the country is to be healthy. However, the vaccine developers work on the pretence of making profits. This can breed a tendency of unethical practices such as data manipulation etc.
In, emergency use situation there are certain unique issues that come to the fore.
- Medical emergency situation v/s Long term impacts: On one hand, many are dying daily in the absence of a vaccine, which prompts us to develop vaccine as soon as possible. On the other we are unaware about the correct biology and mutant bahave of virus, which can be dangerous in the longer run.
- Inadequate chance to expert review: For example, in the present COVID -19 situation, emergency approval is granted without adequate peer review of the data, as the experts of the field allege.
§ Example from this pandemic itself shows that there have been multiple instances of therapies and interventions — from convalescent plasma therapy to a slew of antivirals — that seemed to work well under idealised lab conditions but did not measurably protect in real-world hospital conditions.
Administering a vaccine to a patient, in such a situation ideally two principles should be followed:
- The vaccine must not be provided to the public in general because the long term effects and efficacy of the vaccine are not known.
- However, in an emergency situation like severe risk or illness due to the pandemic, the vaccine can be administered on a case to case basis.
In emergency situations, like the current COVID-19 pandemic, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorization (EUA) allows the medicine or the vaccine to be used on the public.
Conclusion: This is a complex issue which involves looking at the problem from various points of views. There cannot be one size fit all approach that can be used. A case-to-case basis approach fits well.