India: Centre declares Bharat Biotech’s Covaxin is now taken off ‘clinical trial mode’
Bharat Biotech’s Covaxin is now taken off the clinical trial mode, the Central Government announces on Thursday. Moreover, now the vaccine beneficiaries won’t need to sign a consent form before taking the jab.
The clinical trial mode removal was declared a day after the expert panel which was checking the development of the vaccine proposed this to the nation’s Drug Control of India (DCGI).
When the nationwide coronavirus vaccination drive began on 16 January 2021, two vaccines were approved; Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield – developed by Oxford -AstraZeneca. Initially, people receiving the Covaxin shot were required to sign a three-page consent form which expressed; the beneficiary he or she agrees to get the vaccine jab and is informed of the vaccine and its side effects if any.
During the beginning of the vaccine drive, several doctors and healthcare workers were hesitant about taking the Covaxin shot, however, now after the expert panels’ advice the Central Government has eliminated the clinical trial mode from drug. Moreover, the person who takes the shot no more requires a one-week observation by a medical professional.
NITI Aayog member (Health) Dr. V K Paul affirmed in the press conference that Covaxin has been authorized for restricted use in an emergency within the public interest and both vaccines produced by SII now have the same licensure status.
Covaxin has endured in terms of its safety concerns and only 311 people showed minimum side effects. “It is the victory for India’s research, technology, and science,” Paul added.