|Jan 03, 2021, 2:48PM|
DCGI approves two Covid19 vaccines- Astra Zeneca’s Covishield and Bharat Biotech’s Covaxin for restricted use in emergency situationScreen GrabDrugs Controller General of India, DCGI has given approval for restricted use in emergency situation of two Covid19 vaccines- Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.
The announcement for granting permission to these two vaccines 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 (CDSCO) gave its approval followed by the recommendation of the Subject Expert Committee (SEC) that recommended both the vaccines for emergency use.
Mr Somani said that the 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.
Further, the Firm was granted permission to conduct Phase-II and III clinical trial on 1600 participants within the country.
He said, the firm 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.
After detailed deliberations the Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. He said, the ongoing clinical trial within the country by the firm will continue.
Mr Somani said, Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine – Covaxin in collaboration with Indian Council of Medical Research-ICMR and National Institute of Virology, Pune, from where they received the virus seed strains.
He said, this vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and globally.
The DCGI 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.
He said, the Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. He said, the ongoing clinical trial within the country by the firm will continue.
He also informed that permission has also been granted to Cadila Healthcare for conduct of the Phase III clinical trial which has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology.
He also said that the vaccines of Serum Institute of India and Bharat Biotech have to be administered in two doses and all the three vaccines including the vaccine of Cadila have to be stored at 2 to 8 degree Celsius.
Soon after the the Drug Controller General of India (DCGI) approved the emergency use of both Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin for immunisation against Covid-19 in the country, CEO and Owner of Serum Institute of India, Adar Poonawalla said that the vaccine will be rolled out in the coming weeks.
In a tweet he said, COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks and thanked Prime Minister Narendra Modi, Union Health Minister, Dr. Harsh Vardhan, Ministry of Health and Family Welfare and DCGI. Meanwhile, Maharashtra COVID-19 task force head, Dr Sanjay Oak has said that getting vaccinated with Covid-19 vaccine should be considered as the national duty.