India's First COVID-19 Vaccine Gets DCGI Approval For Human Trial

Clay Curtis
July 1, 2020

The SARS-CoV-2 strain was isolated at National Institute of Virology (Pune), an institute under the ICMR, and transferred to Bharat Biotech.

India's first COVID-19 vaccine got the approval for human trials from the country's drug regulator, as number of coronavirus-related cases and deaths continues upward, a drug company announced. The indigenous inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.

The first clinical trial of China's first COVID-19 mRNA vaccine is underway in east China's Hangzhou City.

The agency would require drugmakers to show "clearly demonstrated" proof of a vaccine's safety and effectiveness through a clinical study, and at least 50 percent more effectiveness than a placebo, the Wall Street Journal report said.

The company says that the formula; known as Ad5-nCoV, is now limited to use by military personnel, and can not be offered to a broader population without the approval of the Logistics Support Department, the division of the Central Military Commission which approved the military use of the vaccine. "We're now ready to move forward into clinical development through human trials", Krishna Ella, Bharat's chairman and managing director, said.

M Somasekhar
M Somasekhar

The company also came up with a vaccine for H1N1 or Swine Flu epidemic several years ago.

In the bouquet of 16 Vaccines it has developed and markets, with necessary global regulatory approvals and WHO-pre-qualifications are the Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.

Of the front runners, AstraZeneca's experimental Covid-19 vaccine is probably the world's leading candidate and most advanced in terms of development, the WHO's chief scientist said on Friday.

The vaccine, developed by the military's research unit and a Chinese vaccine company called CanSino Biologics, proved it was safe and showed some efficacy, the company said on Monday. Moderna has signed a deal with Catalent for large-scale manufacturing of its vaccine candidate.

Another 131 candidate vaccines listed by the World Health Organization are at the pre-clinical phase. Catalent is already in partnership with Johnson and Johnson as well as AstraZeneca.

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