New Delhi: 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.
However, there were different voices within the party as its chief spokesperson Randeep Surjewala lauded scientists and researchers of Bharat Biotech for the indigenous vaccine.
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”, prompting a sharp retort from Union Minister Hardeep Puri who said the Congress leaders were behaving “true to their form” and were on a “quest for permanent political marginalisation”.
Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the matter of granting authorisation for vaccine use needs to be taken up carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
India’s drugs regulator DCGI on Sunday approved Oxford’s COVID-19 vaccine Covishield and Bharat Biotech’s Covaxin for restricted emergency use.
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, Sharma said referring to Covaxin.
“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,” Sharma told PTI.
“The restricted use emergency authorisation for the Bharat Biotech vaccine presently undergoing Phase 3 trials raises bonafide concerns.
“Standard protocols and mandatory requirement of publication of data on safety and efficacy which is reviewed and verifiable is important for the integrity of the process,” he said.
Congress leader Shashi Tharoor said the approval is premature and Covaxin’s use should be avoided as it could be dangerous.
“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,” he 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”.
Approval for vaccines accelerates India’s journey to be COVID-free: Modi
NEW DELHI: Hailing the approval given to two coronavirus vaccines as a “decisive turning point” in the spirited fight against the pandemic, Prime Minister Narendra Modi said on Sunday that this will accelerate the process for India to become a COVID-free nation.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford’s vaccine Covishield and Bharat Biotech’s Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
“This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” he said, congratulting the nation, scientists and innovators.
He once again extended his gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all ‘Corona warriors’ for the outstanding work they have done in adverse circumstances, and said the nation will remain eternally grateful to them for saving many lives.
“A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” he tweeted.
The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with Oxford-AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
