A war of words has broken out between the Congress and the BJP over the restricted emergency use authorisation given to the COVID-19 vaccines of Serum Institute of India and Bharat Biotech on Sunday. The Drugs Controller General of India VG Somani on Sunday addressed a press conference and stated that SII’s Oxford vaccine — called Covishield — and Bharat Biotech’s Covaxin have been given approval for restricted use in emergency situations.
Shortly after the announcement, senior Congress leader Anand Sharma on Sunday raised concerns and asked the government to explain why mandatory protocols and verification of data has been dispensed with. Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.
"The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," he told PTI.
"The DCGI statement is puzzling and the government must must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK's MHRA following a government to government agreement signed between the two countries which should be put in public domain to avoid any confusiuon on the proven efficacy of the vaccine," Sharma also said.
He said the news of the imminent arrival and rollout of the nation-wide vaccination drive is "truly uplifting and reassuring" for a country paralysed by the pandemic. It is also a tribute to our scientists, researchers and institutions, who have established India as the largest vaccine manufacturer of the world, he said.
Another senior Congress leader Jairam Ramesh also raised concerns and asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials are being modified.
"Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify," he said on Twitter.
Thiruvananthapuram’s Congress MP Shashi Tharoor also took to Twitter to ask why Bharat Biotech’s Covaxin has been given “premature approval.”
“The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan 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.
However, Union Minister Hardeep Singh Puri led the government’s response to the Congress leaders.
“Our in-house cynics M/s Jairam, Tharoor & Akhilesh are behaving true to form. They first questioned the valour of our soldiers & are now unhappy that the two vaccines to get DCGI nod are made in India. Clearly they are on a quest for permanent political marginalization,” the Union Civil Aviation Minister tweeted.
An expert panel of India's central drug authority had on Saturday recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situations. The recommendation came a day after the panel cleared the Serum Institute of India's emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield. This paves the way for the roll-out of at least two vaccines in India in the coming days, while two more are in advance stages of development.
With PTI inputs