The central government on March 11, 2021 granted restricted emergency use authorisation to Bharat Biotech's indigenously developed Covaxin and said that it is out of the clinical trial mode.
NITI Aayog member (Health) Dr V K Paul confirmed that Covaxin has been granted permission for restricted use in emergency situation in public interest. He stated that both Covid-19 vaccines - Covishield manufactured by Serum Institute and Bharat Biotech's Covaxin have the same licensure status now.
The condition of Covaxin being required to be administered under clinical trial mode is no longer there. Dr. V K Paul further assured saying that Covaxin has stood the test of time in terms of great safety. He said that only 311 individuals had minimal side effects.
He said that this is the triumph for India's research and development enterprise and science and technology enterprise.
PM Narendra Modi was administered the first dose of Bharat Biotech's Covaxin on March 1, 2021 marking the beginning of the second phase of India's vaccination drive. He will receive the second dose in 28 days.
#WATCH: Prime Minister Narendra Modi took his first dose of the #COVID19 vaccine at AIIMS Delhi today. He was administered Bharat Biotech's COVAXIN. pic.twitter.com/VqqBYZDTFU
— ANI (@ANI) March 1, 2021
Background
The Drugs Controller General of India (DCGI) had granted permission for the restricted use of Covaxin in emergency situations in the public interest on January 3, 2021 in clinical trial mode as an abundant precaution, especially in case of infection by mutant strains.
The Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Panel on Covid-19 had recommended granting emergency use authorisation to Covaxin while removing the condition for the vaccine to be administered in "clinical trial mode".
Who will be included in the Phase III COVID-19 vaccination drive?
Dr. V K Paul stated that the government is currently focused on relatively large group of individuals above the age of 60 as well as those aged 45- 60 with comorbidities. He stated that the "centre is building a momentum to cover this significantly large group and then will see its progress and moving forward, a further increase in the circle of those who are eligible will be considered."
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