DCGI approves Covishield and Covaxin- for restricted use in emergency situation
Drugs Controller General of India, DCGI has approved two Covid19 vaccines- Covishield and Covaxin for restricted use in emergency situation.
New Delhi, 3rd Jan: According to Air News, the announcement for granting permission to two Covid19 vaccines- Covishield and Covaxin was made by The Drug Controller General of India VG Somani during a press conference this morning.
The DCGI said, the Central Drugs Standard Control Organisation gave its approval followed by the recommendation of the Subject Expert Committee that recommended both Covishield and Covaxin vaccines for emergency use. Covishield has been developed by Oxford University in collaboration with pharma major Astrazeneca.
India’s Serum Institute is their manufacturing and trial partner.
Covaxin is India’s first indigenous vaccine against Covid-19 developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology. DCGI said Serum Institute of India, Pune submitted safety, immunogenicity and efficacy data generated on 23,745 participants and the overall vaccine efficacy was found to be 70.42 per cent.
He said, the firm also submitted the interim safety and immunogenicity data generated from Phase-II and III clinical trial on 1600 participants and the data was found comparable with the data from the overseas clinical studies.
The DDGI said that the Phase III efficacy trial of Covaxin was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.