Bharat Biotech's COVID-19 vaccine gets DCGI nod for human trials

Bharat Biotech’s Covaxin, the vaccine created by the company against COVID-19, has received approval from the Drugs Controller General of India (DCGI) to enter Phase I and II of clinical trials in humans.

The Hyderabad-based biotechnology company is the first from India to get the nod in the race towards creating the first vaccine against the infectious disease that has claimed more than 516,000 lives and infected over 10 million people around the world. In India alone, over 605,000 have been infected with almost 18,000 people having lost their lives to the infection as of 2 July 2020.

Bharat Biotech has created the vaccine in collaboration with the Indian Council of Medical Research (ICMR), the National Institute of Virology (NIV) and the Thomas Jefferson University of Philadelphia in the United States. This was achieved after the NIV successfully isolated the SARS-CoV-2 virus (the pathogen behind the novel coronavirus infection) and handed it over to Bharat Biotech to study and research treatment methods against it.

Earlier, the company had also received approval to develop COVID-19 monoclonal antibodies—a synthetic method of creating antibodies against the virus in a lab. The Council of Scientific and Industrial Research (CSIR) had given the green signal to accelerate development for new treatment methods against the fast-spreading disease.

COVID-19 vaccine derived from rabies vaccine
Pharma companies in the race for COVID-19 vaccine

COVID-19 vaccine derived from rabies vaccine

According to a press release from Bharat Biotech, its COVID-19 vaccine uses an existing deactivated rabies vaccine as a carrier (vector) vaccine as this is known to produce a strong immune response and is said to be safe for a wider population, including children and pregnant women.

The vaccine was developed by the Jefferson Vaccine Institute's Professor Matthias Schnell, who had explained earlier that the vaccine combines the new coronavirus with a "proven vaccine" which acts as a carrier.

As the carrier vaccine has already been tested and has proven to be effective, there is a likelihood for the vaccine to be successful against the respiratory infection (COVID-19) that has spread all over the world in a matter of six months.

The carrier vaccine, in this case, is a killed rabies vaccine with a spike protein element of the SARS-CoV-2 virus attached to it. One of the reasons rabies has been chosen as a carrier vaccine is the speed with which it can be mass-produced around the world, and given to large human populations to prevent future infections.

According to Prof. Schnell, there are about 20 manufacturing facilities around the world that already produce about 100 million doses of the rabies vaccine every year, which gives them the opportunity to fast-track the manufacturing as well as the distribution of the COVID-19 vaccine.

Bharat Biotech is known for developing vaccines for various infectious diseases such as H1N1 (swine flu), polio, rabies, rotavirus, Japanese encephalitis, chikungunya and Zika. It manufactures as many as 16 vaccines, including a conjugate vaccine for typhoid.

A conjugate vaccine is made of a substance made of polysaccharide antigen which is fused to a carrier molecule, which enhances the efficacy of the vaccine.

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Pharma companies in the race for COVID-19 vaccine

German biotechnology company BioNTech and US-based pharma giant Pfizer have co-developed a vaccine that has also been found to be effective in the early stages of human trials. It works by prompting the creation of antibodies in patients and has been found to be safe.

Another vaccine candidate from the University of Oxford has reportedly gotten the right kind of immune response the researchers were hoping for—about 8,000 volunteers may take part in Phase III of the human trials for the vaccine, which has been licensed to be developed by AstraZeneca.

Another US-based pharmaceutical company Moderna has also shown confidence in its attempt at a COVID-19 vaccine, with top officials hoping for their product to be available this year itself.

Similarly, China's CanSino has moved into the clinical trials stage for its vaccine, with the Chinese military commission already having sanctioned its use, albeit in a restricted capacity.

Read more: Coronavirus vaccine candidates

Pharma enterprises in the UK, Thailand and other parts of the world are also looking to move into high gear in a bid to launch their vaccine early and are in different stages of development.