By Economic Times – DCGI approves SII’s Covishield and Bharat Biotech’s Covaxin for restrictive use in emergency situation The Drugs controller general of India (DCGI) on Sunday announced formal emergency use approval for Oxford-AstraZeneca and Bharat Biotech Covid-19 vaccines.
“Vaccines of Serum Institute of India and Bharat Biotech are granted permission for restricted use in emergency situation,” VG Somani, DCGI said.
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare Ltd, Somani said.
According to the DCGI, “The vaccine efficacy for SII was found to be 70.42%,” Somani said.
However, the efficacy for Bharat Biotech is yet to be ascertained.
According to the Drug regulator, Serum Institute of India, 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. 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 Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue,” he said.
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. According to the drug regulator 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 (Rhesus macaques) and hamsters.
“The results have demonstrated that the vaccine is safe and provides a robust immune response,” Somani said.
“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 been found to be safe as per the data available till date,” Somani further 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. The clinical trial ongoing within the country by the firm will continue.
Experts said that the vaccine of Bharat Biotech will not be administered if the informed consent is not signed by the beneficiary.
Simultaneously, the SEC permitted Cadila Healthcare to conduct Phase III clinical trial in 26,000 participants.
For more details, please visit http://gestyy.com/ethGEA