Vaccination Begins In India, Six Key Aspects That Need Consideration

Prime Minister Narendra Modi will launch nationwide vaccination for COVID-19 on January 16th, six key aspects that need clear policy considerations and proper preparation.

1. However safe the vaccine may be, the post-inoculation side effects cannot be completely ruled out. Even in the United States, severe allergic reactions were reported post immunisation. In medical terminology, they are called adverse events following immunisation (AEFI). The permissions were given to two vaccines subject to certain conditions. The Oxford-Astrazeneca vaccine manufacture at Serum Institute called Covishield is permitted for restrictive and emergency use. Subject Expert Committee (SEC) cleared this vaccine based on the data of phase three trials conducted abroad. In the case of Covaxin developed by Bharat Biotech, the SEC said it was permitted in the public interest that too in clinical mode. Such a language was used as the phase three clinical trials data of Covaxin are not yet available. Given this situation, monitoring of AEFI is much more critical. Expert doctors should be available to deal with such adverse events across the country.
2. The efficacy and safety are two critical factors in vaccination. Any serious adverse events can lead to legal cases. Who will be culpable in case of such adverse events? Will the government or the company that developed the vaccine be legally accountable? Will the citizen be deprived of the right to seek proper compensation in case of any adverse impact due to immunisation?
3. The first phase of the vaccination program rightly includes health workers and other COVID-19 warriors. Identification of other priority groups is critical as enough doses of vaccine will not be available to cover the entire country for some time to come. Reports indicate that age and comorbidity will be the factors to receive the vaccine on priority. But, how to identify people with comorbidity in the absence of an authentic and comprehensive database on the health of Indians. Other vulnerabilities like low immunity, residing in areas having high population density, people working in choked workspaces are likely to be more vulnerable than those with advanced age and comorbidity only. Therefore, comprehensive factors need to be considered to prepare a priority list on an ethical basis.
4. At present two vaccines are rolled out. More vaccines are likely to be permitted over time. In a pandemic situation, a nationwide vaccination program would inevitably have to depend on a mix of multiple vaccines, whose efficacy need not necessarily be uniform. When people have no choice on the type of vaccine, differential efficacy will matter. Besides, the efficacy of the vaccine may vary based on the factors like age, comorbidity, etc. How to address the lack of uniformity in the efficacy of different vaccines?
5. The experience of the pandemic reveals that other illnesses were not properly attended to due to obsession with COVID-19 and also as health systems got overwhelmed with novel coronavirus. This can happen again during vaccination with other equally important immunisation programs getting derailed or delayed. For instance, the pulse polio program is already postponed. The neglect of other immunisation programs may have far reaching public health implications.
6. The Pfizer and Moderna vaccines are also available. They cannot be included in public-funded national vaccination program due to prohibitive costs and the absence of particular cold chain facilities across the countries. Should citizens be allowed to access these vaccines? Ethically speaking, people with paying capacity cannot have the luxury of an early vaccine. But, if more and more people are vaccinated in public or private funded programs, the country can come out of the pandemic at the earliest. What is the way out?

By Prof. K Nageshwar

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