‘COVID-19 vaccine research raises ethical issues’

Vaccine developer company Serum Institute, India said the covidshield vaccine will not be released for mass unless it is proven immunogenic and safe.

The brief summarises the ethical issues that may emerge from the current directions in COVID?19 vaccine research and development during the pandemic.

• A 40-year-old Chennai-based business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Pune-based Serum Institute of India (SII), has sought ?5 crore compensation, for allegedly suffering serious neurological and psychological symptoms after taking the dose.
• The demands: The participant has sought:
  • a compensation of ?5 crore
  • the testing, manufacturing, and distribution of the vaccine be stopped immediately
• Issuing a statement, Serum denied the allegations and said the vaccine is safe and immunogenic.
• The Drugs Controller General of India (DCGI) and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed, to have been suffered by a COVID-19 vaccine trial participant in Chennai are related to the shot administered to him.

What is covidshield vaccine?

• Covishield vaccine is being developed from the “master seed” of the University of Oxford and Aglo-Swedish drugmaker AstraZeneca’s Covid-19 vaccine trial.
• Pune-based Serum Institute of India (SII), the largest vaccine maker in the world by volume, had committed to producing this vaccine even as the trials at Oxford were in the early stage.
• SII is currently conducting the third phase of human trialsin India and hopes to have 100 million doses of this vaccine—which will be given to patients in two doses—by January.
• For the moment, this vaccine is the leading contender in India.

• Every advancement in medicine brings a new set of ethical dilemmas, while a changing world forces us to confront newer challenges.
  • The invention of ventilators pushed mankind to think about end-of-life decisions and the definition of brain death.
  • The outbreak of cholera in a congested city nudged us to reconsider urban planning.
• The discovery of vaccines has been accompanied by concerns of safety and disclosure during clinical trials, and acceptability, accessibility, and affordability.
• Over the years, changing ideas of fairness and equity have been codified into various foundational documents that have generated the guiding principles of biomedical research and health practice.
• Public health crises like COVID 19 that prompt multilateral bodies, including the WHO, and national bodies that govern public health and research to reformulate guidelines.
• But the guidelines often don’t cover many issues in between the silos of medical practice, clinical research, and public health.

Responses to the emergency have raised many ethical issues for the people involved, including public health specialists and policymakers.

• Is it ethical to directly give people a vaccine without complete surety?
• With clinical trials bypassing accepted norms of research, do doctors and patients have enough data to make the right decision on drugs investigated in Indian clinical trials?

Vaccinations have long been the subject of various ethical controversies. The key ethical debates related to vaccine regulation, development, and use generally revolve around three following areas:

• Vaccine research and development: Ethical discussions surround the research and testing of vaccines, including discussions about vaccine development, and study design, population, and trial location.
• Informed consent: Ethical debates also surround vaccine implementation and delivery, such as those concerning informed consent
• Access issues: Many vaccine-related ethical debates center on the evidence that access to vaccination depends to some extent on socioeconomic and racial ethnic minority status.

• Vaccines are the most important public health measure to protect people from COVID?19 worldwide since SARS?CoV?2 is highly contagious and infects populations widely and globally.
• Traditionally, vaccine development takes years, even decades: from about 40 years for polio to 5 years for Ebola, most vaccines took 15 years on average.
• The trial process for vaccines consists of several steps that need to be conducted systematically and in a measurable stride.
• The length of this process is correlated with the nature of the vaccine itself, which is to protect healthy people from being infected by pathogens.
• COVID?19 vaccine will be a great leap forward for humankind, but there are several challenges to overcome:
  • a lack of understanding of the pathogenesis and the predictive role of vaccines in the clinical pathway of persons being infected by SARS?CoV?2
  • a huge disagreement among experts about how to determine the most immunogenic epitopes and antigens of SARS?CoV?2
  • the finding that antibody?dependent enhancement (ADE) may contribute to the exaggeration of SARS?CoV?2 disease
  • the lack of established animal models for COVID?19 vaccine challenge testing, which raises the speculation of using controlled human infection (CHI) as a potential approach
  • speculation that the duration of protection by an immune response in natural infection is not long enough

• Trust issues: Clinical trials in India for drugs to treat COVID-19 lack the rigor needed to make them trustworthy.
• Small number of participants: Ideally these trials should be randomised and controlled, as per the World Health Organization. But current Indian trialshave a small number of participants and are characterized by poor and biased study design. 
• Not adhering to global practices: These trials also do not follow the globally accepted good practiceof being published in peer-reviewed research journals, for the scrutiny of the scientific fraternity.
• Poor scrutiny: There has been poor scrutiny of clinical trials in India where often the emphasis is on cutting costs.

• In a pandemic like COVID, ethics need to be considered in every aspect of crisis management, at every stage:
  • immediate steps to contain and prevent
  • medium-term strategies of care and compensation
  • long-term plans for well-being and rehabilitation
• Ethics are the core foundation for any action, by the state and by the individual.

• Storage and distribution: The first major issue will be the storage and distribution of vaccine as vaccines are needed across the country, and not just in a particular region.
• Lack of infrastructure:Currently India does not have the proper infrastructure and experience of vaccination of people of all age groups.
• Low temperature:The coronavirus vaccine will be needed to be kept at a temperature of -70 degrees Celsius. However, in India, most cold chains operate at temperatures up to -30 degrees Celsius.
• Rate of infection:The country currently has a positivity rate of 8%. Also, the rate of spread of infection has not slowed down. Due to this, the number of patients is increasing every day.

To sum up, the current COVID?19 vaccine research and development raises ethical issues that must be addressed by all stakeholders. Even in the emergency of a pandemic, the urgency of providing an effective COVID?19 vaccine for humankind must be balanced with the exigency of research ethics that must be maintained. In any event, the safety and well?being of research subjects must be protected, especially that of vulnerable subjects.