India ‘s drug regulatory authority on Monday gave the green signal to the COVID-19 vaccine for human trials from Bharat Biotech, making it the country’s first domestic candidate since the number of COVID-19 cases in India crossed 565,000.
The COVID-19 vaccine from Bharat Biotech has been approved for human trials, making it India’s first domestic candidate to get the green light from the government’s drug regulator as cases rise in a country with over 1.3 billion people.
India ‘s Drug Controller General approved the company’s request to conduct a Phase I and II clinical trial of Covaxin, which was developed along with the National Virology Institute of the Indian Council of Medical Research, the company said in a statement Monday.
Human clinical trials are scheduled to commence across the country in July for the vaccine developed and manufactured at the Genome Valley facility in Hyderabad , India, at Bharat Biotech.
India, which in total lags only with the United States, Brazil and Russia, reported nearly 20,000 new infections on Monday, according to data from the federal Ministry of Health.
As his vaccine candidate was approved for human trial by Bharat Biotech, Prime Minister Narendra Modi chaired a high-level meeting on June 30th and reviewed the preparation undertaken for COVID-19 vaccine production. He also inquired about the time period concerning the vaccine’s availability.
According to media reports, Bharat Biotech, a Hyderabad-based vaccine maker, has been given permission by India ‘s Drug Controller General (DCGI) to start human clinical trials for India’s first vaccine candidate against COVID-19.
The vaccine was called Covaxin and is an indigenously produced inactivated vaccine. It was created after Pune isolated a strain of the SARS-CoV-2 from the National Institute of Virology and transferred it to the business. In July 2020, human clinical trials are expected to begin across India.
COVAXIN is India’s ‘first’ indigenous COVID-19 vaccine, developed by Hyderabad-based Bharat Biotech in collaboration with the National Institute of Virology (NIV) and the Indian Council for Medical Research (ICMR).
The indigenous and inactivated COVID-19 vaccine was established at Bharat Biotech’s high containment facility BSL-3 (Bio-Safety Level 3), located in Hyderabad’s Genome Valley.
The DGCI, CDSCO (Central Drugs Quality Control Organization), and the Ministry of Health and Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results obtained from preclinical studies, demonstrating safety and immune response.