India's first Covid-19 vaccine candidate approved for human trials

Elias Hubbard
June 30, 2020

Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19.

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.

Giving details of the trial, he said, "The randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (adverse response to vaccination), and immunogenicity (beneficial immune response) of our investigational SARS-CoV-2 vaccine candidate".

Meanwhile, India's coronavirus burden continues to rise.

"The Ad5-nCoV is now limited to military use only and its use can not be expanded to a broader vaccination range without the approval of the Logistics Support Department", CanSino said, referring to the Central Military Commission department which approved the military use of the vaccine.

India's drug control authorities have allowed Bharat Biotech to hold Phase 1 and 2 of clinical human trials after "company submitted results generated from preclinical studies, demonstrating safety and immune response", a statement issued by the firm added. "Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform", he said.

Vaccine testing typically begins with animal and lab testing before going on to different stages of human testing. The vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins, according to a Business Line report.

Bharat Biotech had manufactured the H1N1 vaccine during the swine flu outbreak. The most significant of their developments is arguably the rotavirus vaccine Rotavac, a next-gen vaccine against a viral gastroenteritis that got pre-approval from the World Health Organization after an Oxford laboratory found it safe and efficacious.

There are now 224 candidate vaccines in development globally, according to the data collected by the Coalition for Epidemic Preparedness Innovations (CEPI).

Pune-based Serum Institute and Delhi-based Panacea Biotec, too, are leading candidates from India to develop a Covid-19 vaccine. Gilead Sciences' remdesivir has been found to be effective in reducing the time spent in hospital by infected patients, but a cure is yet to find.

India registered 18,522 new COVID-19 cases in a single day, taking the country's case count to 5,66,840 while the death toll rose to 16,893 with 418 new fatalities, according to the Union Health Ministry data released on June 30.

The Ministry of Home Affairs has released guidelines for Unlock 2.0, which is expected to come into force till 31 July.

Other reports by Click Lancashire

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