Vaccines spell hope, but govt must clarify doubts
The arrival of a vaccine to counter the Covid-19 pandemic was most keenly awaited in India as this country has the second largest caseload of affected people and an extremely poor healthcare infrastructure. Hence the clearance of two vaccines — Covishield, developed and manufactured by Oxford University-AstraZeneca and the Pune-based Serum Institute of India; and Covaxin, developed by the Indian Council for Medical Research and the Hyderabad-based Bharat Biotech International Ltd — by the Drugs Controller-General of India must have come as a big relief for the people as well as the healthcare sector. An additional factor for an element of pride for India would have been that while Covishield is being mass manufactured in India, Covaxin is a fully indigenous vaccine. With the government already having initiated the process for one of the biggest inoculation processes in the world’s history, with a successful dry run in all states on Saturday, the news would appear to be the beginning of the end of the pandemic, at least in this country.
However, healthcare and immunology experts have been quite sceptical about the greenlighting of the vaccines by the Indian regulator, as well as a section of politicians. They do not question the credentials of the institutions behind the vaccines as every single one has been in the business for quite some time with an impeccable reputation. All that they question is the regulator bypassing globally accepted norms while giving its approval to the vaccines. Covishield has generated enough data for the UK regulator to clear it, but experts point out that there has not been enough data on its trial among the Indian population for the Indian regulator to do the same. As for Covaxin, there is just not enough data on its efficacy from the Phase-3 trials. This has forced the DCGI to give the clearance with riders — it has given Covishield “conditional approval” for emergency use and Covaxin “restricted approval” for emergency use in “clinical trial mode”. It took the director of New Delhi’s All India Institute of Medical Sciences, Dr Randeep Guleria, to put things in some perspective. Dr Guleria, a member of the Prime Minister’s advisory council on Covid, has said the government will go ahead with the use of Covishield in the first phase, when it wants to inoculate about three crore health workers and other frontline workers, and will keep the indigenous vaccine as a standby to use if there is an unexpected spike in the number of new Covid-19 cases, as some of the European countries and the United States are now witnessing, or if the Oxford-AstraZeneca vaccine is found to be inefficient.
Every branch of science, and in this case evidence-based medicine, has its own protocols and processes before it accepts a theory or a product as true and ready for human consumption. Like democracy, it can often be a painfully slow process, but it would be far more sustainable than the rushed ones. India is a beacon of hope for the entire developing world when it comes to the fight against the pandemic, but that is no excuse to be liberal with procedures. It pays to be patient with the ways of science.
Healthcare and immunology experts have been quite sceptical about the greenlighting of the vaccines by the Indian regulator, as well as a section of politicians.