Prime Minister Modi has hailed the vaccination drive that is set to begin soon in India. The Drugs Controller General of India has formally approved two vaccines for restricted use under emergency conditions. They include Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech. There are other vaccines under consideration but the above two seem to have fulfilled the criteria set on how future COVID-19 vaccines will be evaluated and administered. India has been producing vaccines for a long time but none that has been developed indigenously and tested and approved by world bodies. This is why there is a certain worry about the efficacy of the vaccines and/or their side effects. Prime Minister Modi is correct in saying that “Made in India” products should not only have global demand but global acceptance as well. That’s the operative part. Quality control is of the utmost importance.
It is in this regard that the call for transparency is getting shriller. Transparency means establishing the vaccine’s efficacy in the Indian population before rollout, But this final process is being by-passed. This is where the West trumps because there is a clear demand for transparency vide a double-blinded phase- trial where volunteers who get the vaccine and those who don’t and the rate of the disease in both are compared to test the vaccine’s impact. This is the gold standard for evidence-based medicine.
Interestingly while the SII because of its agreement with AstraZeneca has furnished data from a phase-3 trial in the UK and Brazil it has been silent on the effect of the vaccine in 1600 Indian volunteers. Leading vaccine producers namely Pfizer, Moderna, including AstraZenaca have published partial results of the vaccine’s results among their own people before they were given an all-clear signal by respective regulators. Bharat Biotech, which is conducting such a phase-3 trial in India, is yet to furnish similar data because of the delay in recruiting volunteers. Data from Indian companies only attest to the vaccine’s safety and its ability to create immune responses. But Covid-19 has revealed several instances of therapies and interventions that worked well under ideal lab conditions but did not show the desired results outside the labs.
Companies could have been given more time to do a fool-proof trial before authorizing public vaccination regimes. In fact many are of the opinion that those at the helm of government should be the first to receive the vaccines. That said, opacity could harm India’s reputation in the world of medicine. In India, people still do not vaccinate their children from the regular childhood protective doses because of superstitions and fear. The Covid vaccine might face the same fate. Hence transparency and a clear system of communication with the public where all doubts are cleared is imperative.