The Centre’s concern to rollout a vaccine at the earliest and vaccinate 30 crore people in varying orders of priority is laudable. To this end, the Central Drugs Standard Control Organisation (CDSCO) has cleared for emergency use, the vaccines developed by Astra Zeneca-Oxford (made by Serum Institute of India) and Bharat Biotech (in collaboration with the Indian Council of Medical Research and National Institute of Virology). The assumption is that due diligence has been done while granting approval with respect to safety, efficacy and immunogenicity (capacity to trigger an immune response). Any early setback in the vaccine effort, particularly with respect to frontline workers, can derail confidence. While it is difficult to believe that the CDSCO has not satisfied itself about the safety of the vaccines before granting approval, it will certainly help if it is more transparent about the entire approval process. It is fair to argue that that the CDSCO could have taken more time to satisfy itself that the criteria for emergency use — benchmarking them more to the FDA norms than the New Drugs and Clinical Trial Rules, 2019 which follow loosely defined thresholds — have been met. Unlike in the West, India’s case load has been falling. Since September 15 when the daily count was about 84,000, the daily active cases in India have gone down to 18,177 as of January 3. In Tamil Nadu, the number of people testing positive dropped below the 900-mark on January 3, the first time since May 30. In Delhi, the daily count has gone down to 424 in the last 24 hours, the lowest in about eight months.
The clearances have raised questions that the Drugs Controller must address at the earliest. It is not clear if the Subject Expert Committee, on the basis of whose inputs the CDSCO has given its approval, has evaluated efficacy in either vaccine. In the case of the Oxford-Astra Zeneca vaccine it is not clear what data from the foreign trials were used to permit its usage here; likewise, the data on ‘bridging’ or equivalence trials in India, the very basis for rolling out the vaccine here, must also be shared. Similarly, Bharat Biotech does not seem to have produced data on the phase 3 trials being carried out on over 22,000 people. Given the sensitivity of the issue and the doubts raised by health experts, it is only fair to expect the regulator to clarify.
It is remarkable that India has a choice of vaccines, including several indigenous ones in various stages of development, to fall back on in such a short period of time. This is a tribute to capabilities built by the domestic pharmaceuticals industry over the years. While leveraging on this advantage for the benefit of the country it is imperative that due process is not only followed but also seen to be followed. This is not just about combating a disease but also about winning confidence of the people that the vaccines are safe to take.