Covaxin, Indias first COVID-19 vaccine candidate, approved for human trial

Elias Hubbard
June 30, 2020

It is the first indigenous vaccine to have received the drug regulator's approval for trials.

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.

Permission to conduct its clinical trial was granted after the company submitted results from pre-clinical studies of the vaccine, which demonstrated its safety and immune response.

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

The use of the vaccine 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.

Apart from Bharat Biotech, Zydus Cadilla is working on two vaccines, while Biological E, Indian Immunologicals, and Mynvax are developing a vaccine each.

Dr Matthias Schnell, an infectious diseases expert, and his lab at Thomas Jefferson reportedly developed the vaccine in January, after which they completed preliminary tests in animal models that showed a "strong antibody response in mice receiving it", the report adds.

Bharat Biotech's COVID-19 vaccine has been approved for human trials, making it India's first domestic candidate to get the green light from the government's drug regulator. This is a key step for global cooperation on COVID-19 vaccine.

Doctors are also testing various drugs to find out their effectiveness in fighting against the COVID-19 virus. Brazil's Fundacao Osvaldo Cruz would produce the vaccine (~30 million doses initially).

Safety trials are meant to ensure that candidate vaccines are safe for use in humans while efficacy trials are created to determine whether it can protect recipients from the infection.

The company is also involved in the development of CoroFlu, a nasal vaccine for COVID-19, as part of an worldwide collaboration of virologists at the University of Wisconsin-Madison and vaccine firm FluGen.

The company said it was still unclear how the vaccine would perform in humans as human trials are yet to start.

Other reports by Click Lancashire

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