Bharat Biotech on Sunday said the DCGI approval for its COVID-19 vaccine Covaxin is a giant leap for novel product development in the country. Earlier in the day, the Drug Controller General of India (DCGI) approved Oxford-AstraZeneca vaccine Covishield, manufactured by the Serum Institute of India, and Bharat Biotech's Covaxin for restricted emergency use.
"The approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India's scientific capability, a kickstart to the innovation ecosystem in India," Bharat Biotech Chairman and Managing Director Krishna Ella said in a statement.
While this vaccine addresses an unmet medical need during this pandemic, the company's goal is to provide global access to populations that need it the most, he added.
Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist, Ella noted.
The DCGI approval for the vaccines was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation," DCGI Dr V G Somani told a press conference.
This paves the way for the roll-out of at least two vaccines in India in the coming days.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The phase-III human clinical trials of Covaxin began mid-November. Bharat Biotech aims to recruit 26,000 volunteers across the country for the phase-III trials.
It has already crossed the 23,000-volunteers mark so far.
The Hyderabad-based firm said Covaxin has been evaluated in around 1,000 subjects in phase-I and phase-II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.