Indigenous Covid-19 vaccine gets DCGI nod for clinical trial

New Delhi: At a time when the cases of coronavirus are increasing at the rate of over 19,000 infections in a day, the announcement by the indigenous vaccine maker Bharat Biotech of developing India's first vaccine candidate for COVID-19 in collaboration with the ICMR's National Institute of Virology (NIV), Pune has brought relief to the people as well the government.

The vaccine that has been named as Covaxin, which is inactivated, has also got approval from the Drug Controller of India (DCGI) for conducting Phase-I and Phase-II human clinical trials that are slated to begin across the country in July.

As per Bharat Biotech's official statement, the SARS-CoV-2 strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune and transferred to Bharat Biotech, which grew and replicated the virus and developed the vaccine candidate at its BSL-3 (Bio Safety Level-3) high containment facility at Genome Valley in Hyderabad.

Announcing the historic innovation, Bharat Biotech CMD Dr Krishna Ella said that the results from preclinical studies have been promising and show extensive safety and effective immune responses. "Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies," he said.

However, neither Union Health Ministry nor ICMR has made any comment on the development.