Covid vaccine approval: Congress welcome, some leaders object

Hours after DCGI approved indigenously developed 'Covaxin' of Bharat Biotech, Congress party raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials. Congress leaders asked the government to explain why mandatory protocols and verification of data has been dispensed with and warned the approval was "premature". But the party spokesperson Randeep Singh Surjewal in his tweet has said kudos to our scients and researcers of Bharat Biotech on approval.

Kudos to our scientists & researchers of Bharat Biotech on approval of the indigenously developed Corona vaccine & Serum Institute & its scientists too.

India has always lead the way in path breaking innovations in past & will continue to do the same.

Great start for New Year. pic.twitter.com/HbjP5jh7mG

— Randeep Singh Surjewala (@rssurjewala) January 3, 2021

Congress leader Anand Sharma,said the issue of granting authorisation to Bharat Biotech's vaccine 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.

Congress MP Shashi Tharoor also expressed apprehensions over approval to Covaxin, saying it has not yet had phase 3 trials. Jairam Ramesh raised the same concern and said, "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 @drharshvardhan should clarify."

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 @drharshvardhan should clarify. pic.twitter.com/5HAWZtmW9s

— Jairam Ramesh (@Jairam_Ramesh) January 3, 2021