As millions of doses of Covishield and Covaxin get shipped to cities across India a proud moment full of hope and good tidings is somewhat marred by doubts about the regulatory process. The questioning is concentrated around Covaxin where Phase 3 trials are incomplete, and which got approval “in clinical trial mode”. Government spokespersons often rue “less than adequately informed discussion”. But the redress for this is very much with them: Provide the public information more generously and transparently.
Dismissing the questions as politically motivated cannot suffice. When Chhattisgarh health minister TS Singh Deo says that his state will not allow Covaxin because it has not completed the mandatory three trials, this is also the reason why several countries haven’t cleared Chinese and Russian vaccines, where data is patchy and opacity rules. Covaxin developer and manufacturer Bharat Biotech, which enjoys an excellent international reputation, has now been forced into an unattractive defensiveness. In Bengal when Covaxin Phase 3 trials started, urban development minister Firhad Hakim became the first volunteer to get a shot, so, again, the chief minister asking about efficacy data ahead of mass vaccination need not be seen in just a political light.
In healthy democracies citizens robustly demand explanations from government, and overall it is this that safeguards their interests. The unprecedented speed of vaccine advances during the Covid pandemic has left regulators from the UK to Australia and the US scrambling to answer probing questions. In this, India is not unique. In moving forward, it needs to embrace global best practices. For example, in Germany the Chancellor has assured that nobody will be forced to be vaccinated. Because choice, alongside good information, builds trust. Covaxin is going to be administered “in clinical trial mode”, and this is by definition voluntary.
This piece appeared as an editorial opinion in the print edition of The Times of India.
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