- No less than the Honorable Prime Minister Narendra Modi has hailed the Emergency User Approval (EUA) of the Oxford University-AstraZeneca Covishield and the indigenously developed Bharat Biotech’s Covaxin vaccines as a landmark achievement. Lavishing praise on the scientific community for successful inventions, the Prime Minister likened the achievement to Atmanirbhar Bharat ready to take on the might of the dreaded virus head-on. The entire country battered over the months courtesy destructive trail of the pandemic would be rejoicing now and would heave a great sigh of relief as the wait for the vaccine nears the much-anticipated end.
PC: Ankita Bhandari
- With the Drugs Controller General of India granting emergency use authorization to Serum Institute’s Covishield and Bharat Biotech’s Covaxin denotes crossing of the last hurdle before the commencement of anti-Covid vaccination in India. Such path-breaking news should have generated welcome buzz and excitement all around the country. However, evident opacity surrounding data from trials, fast-tracking of data scrutiny, and doubts over vaccine dosage as well as mutations have raised grave concerns. As is its won’t, health experts, scientists, ordinary citizens, and of course, opposition politicians have already raised alarms on the matter.
- Make no mistake, there is a precedent set across the universe in granting emergency user authorization and India is no exception seeking to overcome the debilitating challenges posed by the pandemic with the rollout of the vaccines. Note that, the US is reserving stocks for those needing the second Pfizer/Moderna doses 3-4 weeks later, allowing the rollout to slow down. The UK, in contrast, has proposed up to 12 weeks gap between two doses and is inoculating as many people as possible with the first dose itself. Covaxin began Phase 3 trials in mid-November and needs to inoculate more volunteers. Hence, valid questions are being raised on the efficacy.
PC: Shampa Sen
- The government-appointed Subject Expert Committee was convinced enough that Covaxin’s inactivated virus may be more effective against mutations. On its part, the DCGI has placed conditions on Covaxin like continuous follow-up with vaccine recipients identical to that of trials than a commercial release. While appreciating the tremendous achievements of the manufacturers, the focus should not be lost on ensuring transparency surrounding all critical data related to vaccine manufacturing despite the circumstances demanding urgency. As is known, Russia and China have commenced mass vaccination even before Phase 3 clinical trials shrouded in opacity.
- The trading of a similar path will attract criticism from all corners which will do more harm in puncturing the trust of the nation which is so crucial to rollout universal vaccination. Authorities in key institutions like DCGI, ICMR, and AIIMS have not helped the purpose having spoken in different voices on Covishield and Covaxin. The simple but valid reason quoted by the experts is the lack of availability of empirical trial data to issue informed opinions. Therefore, building trust and speaking in one language from all concerned authorities is imperative. The Union Government will have its task cut out in handling the vaccine rollout issue as well as constant questioning from the opposition.
