India is fully equipped to undertake the mammoth initiative of distribution of Covid vaccines, says Dr Puneet Misra, professor, Community Medicine, All India Institute of Medical Sciences, New Delhi. Organiser spoke to him on Covid vaccine rollout. Excerpts:
There were complaints of side-effects of vaccines in India and elsewhere during trials. This has given rise to a lot of speculations and fears about their safety. Is it a cause of worry?
Recent reports about the side-effects of a Covid-19 vaccine during its clinical trial in the UK is bothering a lot of people. The reports said that the reaction caused due to anaphylaxis. If this is true, we should know that anaphylaxis can occur due to any substance or drug. That’s why we do testing before full dose injection of a lot of medicines, including penicillin. It could be due to active ingredient in the vaccine. Most likely it must have caused from some constituent which is used in the vaccine. Side-effects, many a time, are due to constituents used for preservation and preparation of vaccine products. Many well-known medicines and vaccines are known for their allergic reactions in some group of susceptible people.
The data regarding side-effects and safety from all the vaccines undergoing trials have been generated from limited number of volunteers in limited time due to urgency because of the pandemic situation. Many side-effects may be visible when we take large sampleas these may not be so common, and can be known after administering vaccine to a larger number of participants after a longer period of observation.
It is the responsibility of a vaccine manufacturer and regulatory authority to keep a tight vigil on participants to whom a vaccine has been given under emergency use licence for its side-effects before it can be given to larger population.
Distribution of vaccines is a huge challenge for a country like India. Do you think India is equipped to undertake this task?
In the context of India, we are lucky that we run one of the biggest vaccination programmes in the world to immunise our infants and children every year. We have a huge number of trained manpower in all corners of the country. Also we have a system of cold-chain maintenance up to the level of primary health centres and sub-centres. All districts have facilities for keeping vaccines at low temperatures (up to -20 degrees centigrade) to keep them safe. We have capacity to transport vaccines in cold-chain from the manufacturer to the recipient even in remote villages in required temperature setting. We have demonstrated our capacity even in far-flung and difficult-to-reach areas during the Pulse Polio immunisation, be it was a desert area or areas under layers of snow. So we have very robust functional system in the government sector which can ensure smooth and timely delivery, proper storage at all levels, be it at district or Primary Health Centre, along with its distribution even to the weakest section in the society. To make it even more strong, authorities are planning to take help of other sectors as and when required to save lives and health of our citizens.
Anything which is done with serious and honest efforts would lead to desired results. What I see which make it different this time is strong political commitment which help in infusing strong confidence among scientists, doctors, and public. Best part is all the preparation are being directlymonitored at the apex level under leadership of Prime Minister Narendra Modi himself.
Has India measured up to the challenge with regards to Covid vaccine race? Has the quest for vaccines helped India in building her capabilities?
I would like to say that not only vaccine, but in all aspect of Covid-19 prevention, India did a commendable job. See at PPE kits, we were not producing any at the time of start of pandemic, now we are producing not only enough for the country but can export as well. We are producing millions of PPE kits every week. We have strengthened our hospitals to take of huge number of cases and could manage to save lakhs of lives. India’s mortality rate is very low as compared to many developed countries. We could feed our 1.3 billion population without difficulty at the time of worldwide crisis in terms of pandemic and lockdowns.
I think we have learnt a lot. We are moving in the right direction, be it vaccine research, vaccine testing, vaccine manufacturing, saving lives or making life as normal as possible during the pandemic. This is a great achievement.
What types of COVID-19 vaccines are being tested?
Globally, 36 COVID-19 vaccines are under clinical evaluation (till the time of going to the press). In India, three vaccines have already reached the clinical trial stage: Covaxin by Bharat Biotech, Zy-CoV-D by ZydusCadila, and AZD1222 by Serum Institute of India (SII). Covaxin is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. It has received approval by the Drugs Controller General of India (DCGI) for Phase 1 & 2 Human Clinical Trials, and the Phase 1/ 2 (a combination of phases 1 and 2) clinical trial has already started. The adenovirus vectored plasmid DNA COVID-19 vaccine by ZydusCadila received DCGI approval for Phase 1 & 2 Human Clinical Trials a few days after the Covaxin was approved in July 2020. SII has got the approval of recombinant adenovirus vectored COVID-19 vaccine to start the Phase 2/3 (a combination of phases 2 and 3) clinical trials at 17 sites in India. n
