“There Are Laid Down International Norms For Vaccine Initiation”

Dr Godwin Nchinda, Senior Immunology, Deputy Director General, CIRCB.

What are the steps a vaccine will need to go through during development? 
Vaccines are less dangerous components (parts) of a disease causing agent which are used to provoke the body to develop an ability to resist the disease causing agent when its challenges the body again. This is, resistance from infection by a disease causing agent following vaccination which is called immunity. A vaccine against SARS-CoV-2 virus (COVID-19) must protect people from being infected with the virus. That is to make people acquire immunity against COVID-19. Unfortunately, there is no validated vaccine against COVID-19. To validate a vaccine for use in people, scientists must follow well documented logical steps to ensure that the vaccine is safe and capable of protecting people against the disease. There is an exploratory stage, pre-clinical stage, clinical stage, regulatory Review and Approval stage as well as the Manufacturing and Quality Control stage. 


What are the international ethical considerations and guidelines patterning to the development and use of any vaccine?
The International Ethical Guidelines for Biomedical Research Involving Human Subjects as proposed by the Council for International Organizations of Medical Sciences (CIOMS) are clearly stated in the 1993 version of the CIOMS International Ethical Guidelines. It contained a requirement that the early phases of vaccine research (phase one and perhaps phase two) should be carried out in the country of the sponsoring agency. This requirement was designed to protect the low-resource countries and communities from exploitation. Since the 1970s, there has been a general expectation reflected in the ethical codes and guidelines that special justifications are required to involve vulnerable populations in research programs in which there are serious risks presented by interventions or procedures that do not hold out the prospect of direct benefit to the individual subjects. Also, CIOMS International Ethical Guidelines indicate that external sponsors of research are ethically obliged to ensure the availability of healthcare services that are essential to the safe conduct of the research and also treatment for subjects who suffer injury as a consequence of research intervention. 


What sort of progress is being made as far as a vaccine against the Coronavirus is concerned? 
Given the newness of the epidemic most of the vaccines are in phase I/II. Nevertheless, there happens to be a massive global race to be the first to develop the vaccine. We want to applaud the progress being made so far. Mankind is demonstrating high level innovation in expediting the process of vaccine development. Preliminary results are very promising and I do firmly believe that a vaccine is coming in the no distant future!
Why is there so much polemics surrounding the Coronavirus vaccine trial? 
The sheer size of this pandemic has sent shock waves down everybody’s spine. Never in the history of mankind have we witnessed this. Everything coming to a standstill! This instils a lot of fear. The fear of the unknown, global ignorance about the disease outcome, global ignorance about immunity, global ignorance about the best treatment, global ignorance about getting well, no validated experts or clinicians of COVID-19, over...

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