Bharat Bio to start human trials for indigenous Covid vaccine in July

Cheryl Sanders
June 30, 2020

The British drugmaker has already begun large-scale, mid-stage human trials of the vaccine, which was developed by researchers at the University of Oxford. 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.

Once the trial starts, the effectiveness of the vaccine in generating a safe immune response will be assessed in dozens of healthy human volunteers.

The trials are among many across the world - there are around 120 vaccine programmes under way.

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.

After it showed promise in preclinical studies, demonstrated extensive safety and exhibited effective immune responses, the Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials.

The two trials are created to test whether the vaccine is safe, rather than whether it is effective. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine.

"We're now ready to move forward into clinical development through human trials", Krishna Ella, Bharat's chairman and managing director, said.

Other Indian firms engaged in the development of Covid-19 vaccines include Zydus Cadila, Serum Institute of India and, since the beginning of this month, Panacea Biotec.

As coronavirus cases rise globally, the race for developing a vaccine is also picking pace.

Johnson & Johnson is preparing the ground for the entry of a vaccine against COVID-19 and is expanding its manufacturing capacity to supply more than one billion doses through 2021 in a not-for-profit project aimed at the common person, says its top scientist.

A strain of the new coronavirus, isolated in a government lab in Pune and killed with chemicals, will be India's first home-grown candidate vaccine against Covid-19 to head into human safety and efficacy trials.

Media captionCoronavirus: What is a vaccine and how is one made?

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