Immediately after India approved two Covid-19 vaccines- Covishield and Covaxin- for emergency use , a huge controversy broke out on the permission accorded to Covaxin, Hyderabad-based Bharat Biotech’s home-grown vaccine. Questions have been raised over the the DCGI'a approval to this vaccine in the absence of any efficacy data. It is being alleged that the nod given to Covaxin violates standard clinical practices.
Congress leaders like Shashi Tharoor questioned the approval given to covaxin and alleged that the DCGI action was "premature". The ICMR, on the other hand, clarified that the approval has be given for restricted use only. Taking strong exception to congress leaders' remarks, union health minister Dr harsh Vardhan said that the Opposition was deliberately spreading rumours.
What is COVAXIN controversy?
Bharat Biotech’sCovaxin has got approval from the DCGI but its phase-III trial is yet to be completed. According to critics, neither any data proving the vaccine’s efficacy nor any results of an interim analysis have been shared in the public domain so far.Bharat Biotech had published data on a non-peer-reviewed website on December 22 relating to its phase 2 trials with a follow-up on its phase 1 trial. The data showed that the vaccine was safe with no serious adverse effects having been observed.
Bharat Biotech was granted permission to conduct phase 3 trials on 25,800 volunteers on 23 October — making it the country’s largest-ever efficacy trial and on December 22, the company claimed that it had crossed the half-way mark after recruiting over 13,000 volunteers. However, the phase 3 trial is still undergoing and the DCGI's approval before the completion of the trail is the root cause behind the present controversy.
What does ICMR, other experts say?
The Indian Council of Medical Research (ICMR) director general Dr Balram Bhargava refuted claims that phase 3 trial data for Bharat Biotech's Covaxin shot was not evaluated, saying the emergency use authorisation (EUA) was given after meticulous review of data of 22,500 persons which established safety of the shots.
"The phase 3 data has been completed for 22,500 patients and the safety was fully established. That has been submitted and the full trial of 25,800 persons will be completed in a week's time," Bhargava said, underlining that by the time the vaccination programme is launched, the Phase 3 trial for Covaxin will be concluded and final set of data will also be available.
"The immunogenicity is 98% and we have had no cases of Covid in the phase 1 or phase 2 and the animal studies and challenge studies have shown full
efficacy compared to any other vaccine in the world," he added.
The ICMR DG further pointed out that all vaccines approved globally are for emergency use including those by Pfizer, Moderna and the Oxford vaccine. "We are dealing with a world war, so at this point, we have to look at what is going to be beneficial for society at large and these are not full approvals at all - neither Covishieldnor Covaxin."
Justifying the approval given to Covaxin, AIIMS director Dr Randeep Guleria told ANI that the shot "can also be used as a backup when we're not sure how efficacious the Serum Institute vaccine is going to be."
Political faceoff over COVAXIN approval
Some Congress leaders on Sunday raised serious concern over the grant of approval to Bharat Biotech's COVID-19 vaccine for restricted use, saying it is "premature" and can prove dangerous.
Leaders like Anand Sharma, Jairam Ramesh and Shashi Tharoor asked the health minister to explain why mandatory protocols and verification of data “had been dispensed with”.
“The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. Dr Harsh Vardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” Tharoor tweeted.
Another senior Congress leader Jairam Ramesh asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials “are being modified”.
Health minister Harsh Vardhan strongly backed the Covaxin shot, saying "For those spreading rumours let it be known that EUA for Covaxin is differently conditional - in clinical trial mode"
He explained this means its use will be in "clinical trial mode" where all recipients are monitored as if they are in trial.
"This approval ensures India has an additional vaccine shield in its arsenal especially against potential mutant strains, a strategic decision for our vaccine security," he said.
An enraged Harsh Vardhan went to the extent of terming the criticism of opposition leaders as "disgraceful".
"Disgraceful for anyone to politicise such a critical issue. Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don't try to discredit well laid out science-backed protocols followed for approving #COVID19 vaccines. Wake up & realise you are only discrediting yourselves," he tweeted.
