Emerging landscape of COVID-19 vaccines in India as of 31 July: Bharat Biotech, Serum Institute, Zydus at the helm

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Over a dozen Indian companies are in partnership with other firms and institutes to bring a preventive vaccine into global markets by 2021.

Three Indian companies have begun testing vaccines for COVID-19 in humans in expeditious trials. However, there are over a dozen Indian firms in partnership with other companies and institutes – both in India and abroad – to bring a working vaccine against the SARS-CoV-2 coronavirus into global markets.

Here’s an overview of different candidates from Indian companies that have declared their progress (or intent) to develop a vaccine against the novel coronavirus, as of 31 July 2020.

Bharat Biotech 

Bharat Biotech, in a partnership with the National Institute of Virology, began recruiting volunteers for Phase 1 trials to test safety and neutralizing antibodies of its Covaxin (BBV152) vaccine candidate in 375 healthy volunteers as of 13 July.

Based on how volunteers respond in these trials, Bharat Biotech intends to continue with a multicentre, randomized, double-blind Phase 2 trial with 750 volunteers to see how safe and effective the BBC152 vaccine is in a larger group.

Bharat Biotech is also in collaboration with Thomas Jefferson University to develop a recombinant deactivated rabies virus containing the spike protein against SARS-CoV-2. With the Department of Biotechnology’s backing, Bharat Biotech is aiming to enter human trials with the vaccine by December 2020.

Serum Institute of India

Serum Institute of India is currently carrying out a randomized, double-blind study of a recombinant BCG vaccine (VPM1002for severe cases of coronavirus infection. The vaccine is a further development of the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine still widely used to treat tuberculosis. In the ongoing Phase 3 trials in 5,946 volunteers, Serum Institute is testing whether the vaccine reduces the severity of COVID-19 in high-risk patients.

Serum Institute has also said it will begin testing for the Oxford-AstraZeneca vaccine (AZD1222) candidate in India soon. It received a no-go from Indian regulators for its trial protocol this week, and is expected to run a revised version by Indian regulator (CDSCO) in a few days’ time. After promising results in mid-July from early trials the experimental Oxford-AstraZeneca vaccine, Serum announced it will manufacture a billion doses of the vaccine after seeking the required approvals.

Serum Institute, in partnership with US-based Codagenix, is developing a live attenuated COVID-19 vaccine candidate CDX-005, which is in pre-clinical trials as of July 2020.

Emerging landscape of COVID19 vaccines in India as of 31 July Bharat Biotech Serum Institute Zydus at the helm

An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharath Biotech. Image: Bharath Biotech

Zydus Cadila

Zydus Cadila Healthcare, backed by the Department of Biotechnology (DBT), began recruiting for its phase 1/2 clinical trials on 13 July to test for safety and efficacy of its DNA plasmid ZyCoV-D vaccine candidate in 1,048 volunteers. In the pre-clinical phase, ZyCoV-D produced a strong immune response in multiple animal species including mice, rats, guinea pigs and rabbits, and raised no safety concerns.

A second measles vector vaccine candidate for COVID-19 from Zydus is currently in pre-clinical trials.

Panacea Biotec

Panacea Biotec has entered into a Joint Venture partnership with US-based Refana to develop, manufacture and distribute a COVID-19 vaccine candidate globally by next year. The Ireland-based joint venture is working on an inactivated SARS-CoV-2 vaccine, adding in an interview with Reuters that the vaccine is currently in animal pre-clinical trials, with Phase 1 human trials likely to begin only after September 2020.

It has targeted producing 500 million doses in 2021 and one billion doses of its vaccine candidate in 2022, as per the report.

Indian Immunologicals

Indian Immunologicals and Australia’s Griffith University entered a partnership to develop a potential COVID-19 vaccine candidate that could provide “long-lasting protection with a single dose,” as per an April press release.

The company intends to take over live attenuated vaccine strain once developed, and carry out clinical trials under Indian regulators in a phased manner. The vaccine development is currently in pre-clinical stages as per WHO’s vaccine tracker as on 31 July.

Emerging landscape of COVID19 vaccines in India as of 31 July Bharat Biotech Serum Institute Zydus at the helm

The J&J vaccine, which enters Phase 2 trials in late-July after successfully protecting monkeys from COVID with a single shot. Image: JnJ

Mynvax

Indian Institute of Science-incubated start-up Mynvax has received funding and support from the Bill and Melinda Gates Foundation to develop a series of recombinant subunit vaccines for SARS-CoV-2. The vaccine will be primarily aimed at the most at-risk groups for COVID-19 (health workers, senior citizens and people with co-morbid conditions).

Mynvax said in a May update that selection and preclinical trials have been completed for many candidates, with more being screened “over the next few months.” Mynvax has also applied for Rs 15 crores in funding from the Biotechnology Industry Research Assistance Council (BIRAC) to scale-up and manufacture successful candidates.

Other Indian companies in pre-clinical trials

Biological E has also been backed by the Bill and Melinda Gates Foundation. The company is developing a protein subunit vaccine using the part of the SARS-COV-2 virus’ spike protein. The vaccine candidate is in pre-clinical trials as of 31 July 2020.

Aurobindo Pharma based in Hyderabad is also presently conducting pre-clinical tests for its replicating viral vector vaccine against SARS-CoV-2.

Premas Biotech based in Gurugram is reportedly working on a triple-antigen vaccine candidate, and has successfully identified three antigens with which to develop independent recombinant vaccine candidates against SARS-CoV-2.

Ahmedabad-based Hester Biosciences in collaboration with IIT-Guwahati is reportedly developing a vaccine against COVID-19 using a recombinant avian paramyxovirus vector. Primarily an animal healthcare firm, and the second largest poultry vaccine manufacturer, this will be the company’s first foray into human vaccines.

Gujarat Biotechnology Research Centre (GBRC) has partnered with Neuberg Supratech, an Ahmedabad-based pathology lab under Neuberg Diagnostics, to develop COVID-19 recombinant vaccines and diagnostics.

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