Let data-led safety and efficacy be the only criteria for rolling out Covid-19 vaccine, not nationalism

January 6, 2021 5:45 AM

It is in the interest of the country and its people that all the questions around vaccine approval are properly addressed

vIndia’s regulators approved AstraZeneca’s vaccine with the standard regimen of full two doses between shots, which is 62.1% effective based on phase III clinical trial results published by the company in the Lancet in December.

By Dr Debkishore Gupta

The emergency use approval to two ‘made in India’ Covid-19 vaccines is a historical moment for the country given that these are the first vaccines to get the green signal and a step towards the inoculation drive of some 250 million people. Unfortunately, the decision has been received with mixed feelings, and rightly so. The move by the government has raised several pertinent questions regarding the whole approval process and whether there exist enough data for grant of approval, especially in the case of Covaxin by Bharat Biotech that has received criticism for having inadequate trial data. The fact that top health officials have made major claims about how Covaxin might perform for mutations of the virus even though efficacy trials and data aren’t complete could be a major concern.

At the same time, while there was no such issue with Covishield, the other vaccine by Serum Institute, the DCGI did not specify the conditions in which Covishield was allowed for ‘restricted use in emergency situation’. While we can bask in our own glory, the question is that in absence of data from phase III trial is it the right time for any of these vaccines to get the approval?

Notably, Covaxin has completed only two of the three required phases of clinical trials. While the earlier studies on monkeys and hamsters had found the vaccine can provide ample protection against the coronavirus, but the efficacy data from the ongoing phase III trial covering 24,000 volunteers was only expected by February. Still, it got emergency use approval, leading to a sense of scepticism around the efficacy of this vaccine. It may not be fair to roll out an incomplete vaccine for the people of India who have every right to exercise their choice to avail the one that has all the safety and efficacy elements proved.

India’s regulators approved AstraZeneca’s vaccine with the standard regimen of full two doses between shots, which is 62.1% effective based on phase III clinical trial results published by the company in the Lancet in December. Any mention of the other numbers creates confusion over dosages and efficacy of the vaccine.

It is in the interest of the country and its people that all the questions around vaccine approval are properly addressed given that the approval for all vaccines (from an indigenous maker or a foreign manufacturer) must be provided on the basis of adequate evidence of efficacy and safety.

The other big question in a country like India is the vaccine roll-out.

There have been discussions around reducing the number of doses or making other changes in the regimen such as length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunise more people against Covid-19. These experiments should be considered only on solid evidence. However, I firmly believe following the authorised dosing schedules will be key. This is in line with the US FDA’s January 4 statement stressing that making changes to dosing or schedules could be dangerous for public health unless such alterations are rooted solidly in available scientific evidence based on clinical trials data.

Without appropriate data supporting such changes in vaccine administration, we run a significant risk of putting public health at jeopardy, undermining the historic efforts of vaccination drives by the country. Even as we celebrate India’s decisive step to resolve the Covid-19 situation, it would be advisable to look beyond just nationalism and take into consideration the science behind every vaccine and the proof points that establish their safety and efficacy. Hasty approvals, incomplete trials and a lack of transparency could create doubts in the minds of people and keep them away from Covid-19 vaccination.

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