Published 12:19 IST, January 3rd 2021
India's COVID vaccines: With Covishield & Covaxin nods, Cadilla's phase 3 also approved
The SEC of the CDSCO had made recommendations to the DCGI to grant permission for restricted emergency use of the SII & Bharat Biotech's Covid vaccine
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Drugs Controller General of India (DCGI) has granted permission to vaccines of Serum Institue of India and Bharat Biotech for restricted use in emergency situations on Sunday, essentially approving them for use. The DCGI also announced that Cadila Healthcare Ltd's COVID-19 vaccine using DNA platform technology has been given an approval for phase 3 clinical trials.
Cadila Healthcare's COVID-19 vaccine
"The Cadila Healthcare Ltd has has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee" the DCGI said at the same media briefing where they also announced the approval for Covishield and Covaxin vaccines.
The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of the Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd. They also announced that M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses and all the vaccines have to be stored at 2-8° C.
12:19 IST, January 3rd 2021