Congress leaders raise concern over DCGI approval
New Delhi, Jan 3: 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.
Congress leader Shashi Tharoor said the approval is premature and Covaxin’s use should be avoided as it could be dangerous. (PTI)