The Drugs Controller General of India (DCGI) has given g ahead to two “Made in India” COVID-19 vaccine developed by Oxford-AstraZeneca and Bharat Biotech. Prime Minister Narendra Modi said this shows the eagerness of India’s scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.
“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances,” the PM tweeted. “We will remain eternally grateful to them for saving many lives. A decisive turning point to strengthen a spirited fight!” Modi highlighted that the regulator granting approval to vaccines of Serum Institute of India (SII) and Bharat Biotech accelerates the road to a healthier and COVID-free nation.
VG Somani, DCGI, at a briefing said the vaccines of both pharmaceutical companies are being approved for restricted use in emergency situations. “The Subject Expert Committee (SEC) of Central Drugs Standard Control Organization met on 1st and 2nd January, and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of SII and Bharat Biotech, as well as Phase III clinical trial of Cadila Healthcare Ltd,” he said.
SII, according to the Drug regulator, submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. Serum was granted permission to conduct Phase II/III clinical trial on 1600 participants within the country. It also submitted the interim safety and immunogenicity data generated from this trial, and the data was found comparable with the data from the overseas clinical studies.
Bharat Biotech which has developed a whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. The drug regulator said the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates and hamsters.
Somani said the results have demonstrated that the vaccine is safe and provides a robust immune response. “The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has has been found to be safe as per the data available till date.”