Bharat Biotech Develops India's First Coronavirus Vaccine, COVAXIN

India’s 1st COVID-19 vaccine gets human trial approval

According to media reports, the Hyderabad-based vaccine manufacturer, Bharat Biotech, has been accorded permission by the Drug Controller General of India (DCGI) to initiate Phase I & II human clinical trials for India's first vaccine candidate against COVID-19.

Bharat Biotech's track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.

Many countries around the world have managed to get a handle on the novel coronavirus pandemic, but until we have a safe and effective vaccine, we're going to have to continue to take drastic measures to protect ourselves and our neighbors.

The indigenous, inactivated vaccine was developed from a SARS-CoV-2 strain, which was isolated by the NIV and transferred to the company's BSL-3 High Containment facility located at Hyderabad city in southern India, Bharat Biotech said in a statement.

The vaccine has shown promising results in preclinical studies, demonstrating extensive safety and effective immune responses. Furthermore, the support and the guidance from CDSCO had enabled approvals to the project, Ella stated.

Ahmedabad-based Cadila Healthcare was the first among Indian players to announce a vaccine candidate - it had also started pre-clinical studies.

The agency also said it would require drug companies to monitor the vaccine's performance after approval for any emerging safety problems. University of Oxford's vaccine is the furthest in the trial, now in the third phase, while there are various candidates in the second phase. It signed its tenth supply-and-manufacturing deal earlier this week.

"The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines", Gregory Poland, director of Mayo Vaccine Research Group said.

Hong Kong-listed CanSino Biologics said in a filing to the stock exchange that data from clinical trials showed the Chinese military vaccine had a "good safety profile" and potential to prevent disease caused by the novel coronavirus.

Bharat said it had the capacity to produce 300 million doses of the vaccine per year.

Moderna, AstraZeneca, Johnson & Johnson, Merck and Sanofi all have funding from Operation Warp Speed.



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