New Delhi: While vaccines for Covid-19 are likely to be available soon, it may take several months to establish the safety, immunogenicity (ability to trigger an immune response) and efficacy criteria, says an editorial published in the Indian Journal of Medical Research (IJMR).
A publication of the country’s apex medical research body Indian Council of Medical Research, IJMR is a peer-reviewed online journal with monthly print issues.
According to the editorial written by Rajesh Bhatia, former director, communicable diseases, World Health Organization, South-East Asia, “unprecedented and globally coordinated research and efforts are likely to result in availability of some, if not several, vaccines against COVID-19 in the next few months”.
However, he said, it may take several months before global demand as well as safety, immunogenicity and efficacy criteria are fully met.
“The challenge would be to ensure their optimal and cost-effective use. Despite support from the international community, the cost of procurement of vaccines and its deployment for every citizen may be exorbitant for most of the developing countries.”
Earliest availability of Covid-19 vaccine is projected to be late 2020 to mid-2021, IJMR’s report said. “The world is estimated to need around 16 billion doses of vaccine in the immediate future. It is a huge challenge to meet this global requirement in a short period.”
“While an affordable vaccine is the need of the hour, high production and administration cost should force countries to innovate, prioritize and think out of the box to make the best use of this intervention with the sole objective to immediately eliminate the pandemic.”
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Potential risks associated with vaccines yet to be explored
According to the author, an undetermined risk of Covid-19 vaccine causing disease enhancement or an acute autoimmune disease through a T-cell-mediated damage or adverse effect due to antibody is yet to be explored.
Bhatia has advocated for the post-marketing surveillance of Covid vaccines to register the side-effects.
“Vaccines for many other diseases including influenza and measles have been associated with such unwanted and damaging events. Such events may be detected through post-marketing surveillance of COVID-19 vaccine.”
“It is essential to generate reliable data on long-term safety of vaccines to inspire confidence in communities and their acceptance of vaccines.”
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Prior evidence of safety, efficacy needed for elderly, pregnant women, children
The editorial said clinical trials are conducted in “defined adult populations” and added that the vulnerable populations are excluded from these.
“Since COVID-19 immunization is targeted for the entire global population, it shall require prior evidence of efficacy and safety in several subpopulations, especially the elderly, pregnant women, children below 18 yr of age and those who are immunocompromised or living with co-morbidities.”
The author warns that the role of vaccine in protecting the elderly with or without co-morbidities (over 60 years of age) and inducing immunity in children in whom this coronavirus has the “potential to cause paediatric inflammatory multisystem syndrome” needs to be explored on priority through the generation of unequivocal scientific evidence.
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