Emerging landscape of COVID-19 vaccines in India, 14 Aug: Bharat Bio, Zydus move to Phase 2; Biological E, Bayor College tie up for COVID-19 vaccine
Over a dozen Indian companies are in partnership with other firms and institutes to bring a preventive vaccine into global markets by 2021.
Editor's Note: This story was originally published on 31 July, and updated on 14 August to include updates on candidates from Bharat Biotech, Zydus Cadila, Biological E and Serum Institute.
Two Indian companies are now in adaptive Phase 1/2 human trials of a potential COVID-19 vaccine in volunteers. There are, however, over a dozen Indian firms in partnership with companies and institutes – both in India and overseas – to bring a working vaccine against the SARS-CoV-2 coronavirus into markets.
Here's a brief overview of the various vaccine candidates that Indian companies are working on as of 13 August 2020, as well as some others that have declared progress or intent in developing a vaccine against the novel coronavirus.
Bharat Biotech, in a partnership with the National Institute of Virology, has concluded phase 1 human trials of their COVAXIN candidate at most of the 12 chosen centres as of 14 August. The results from the preliminary trial suggests that the vaccine is safe, principal investigators conducting the trials told the Economic Times.
Now, the 12 trial centres have moved on to recruiting volunteers for phase 2 trials, in which the vaccine's efficiency will be tested to check for an immune response against the coronavirus. Phase 2 is scheduled to begin in the first week of September.
Now that Phase 1 trials have concluded, 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.
The preliminary Phase 1 trials were carried out to test safety and to check whether Covaxin (BBV152) could produce any neutralizing antibodies against SARS-CoV-2. 375 healthy volunteers were part of the trials, which began in mid-July in 12 centres across India.
Apart from Covaxin, Bharat Biotech is 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 this second vaccine candidate by December 2020.
Bharat Biotech is also partnered with University of Wisconsin–Madison and FluGen to develop a vaccine against SARS-CoV-2 using an influenza virus vector. The candidate is currently in pre-clinical animal trials as per a 13 August update from WHO.
Serum Institute of India
Serum Institute of India is currently carrying out a randomized, double-blind study of a recombinant BCG vaccine (VPM1002) for severe cases of coronavirus infection. This vaccine is a further development of the popular 100-year-old Bacillus Calmette-Guérin (BCG) vaccine still widely used in tuberculosis prevention globally.
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.
"We are delighted to partner with DBT-BIRAC for this study and look forward to the positive results of the trial, which should be available before the end of this year,”Adar Poonawalla, owner and CEO of SII is quoted as saying by the Press Information Bureau.
Serum Institute has partnered with AstraZeneca and Oxford University to manufacture the Oxford COVID-19 in India. On 10 August, Serum Institute said the vaccine will be priced at Rs 225 per dose in India.
After promising results from Oxford's early trials rolled in mid-July, Serum announced it will manufacture a billion doses of the experimental Oxford-AstraZeneca vaccine after seeking required approvals.
The vaccine is presently undergoing Phase 3 trials in various countries, and Serum is said to begin testing for the Oxford-AstraZeneca vaccine (AZD1222) candidate in India soon, as per regulatory requirements. It received a no-go from Indian regulators for its trial protocol, after which the revised version was accepted by the Indian regulator (CDSCO) days later.
SII announced a new partnership with global vaccine alliance GAVI and the Bill & Melinda Gates Foundation to accelerate manufacturing and delivery of up to 100 million doses of COVID-19 vaccines for India as well as other low and middle-income countries.
Zydus Cadila, backed by the Department of Biotechnology (DBT), has successfully passed a test of safety (Phase 1) of its DNA plasmid ZyCoV-D vaccine candidate in 1,048 volunteers on 5 August 2020. An adaptive Phase 1/2 trial to test for safe dosage and efficiency of the vaccine was started in over 1000 healthy adult volunteers on 6 August.
Zydus said it is hopeful of completing Phase 2 trials for ZyCoV-D by September-October in an interview with CNBC-TV18. 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 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 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 of 13 August.
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 public update in May 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.
Biological E, another Indian drugmaker backed by the Bill and Melinda Gates Foundation, is developing a protein subunit vaccine using part of the SARS-COV-2 virus' spike protein. The vaccine candidate is in pre-clinical trials as of 13 August 2020.
Biological E is in a licensing agreement with Houston-based Baylor College of Medicine to develop a COVID-19 vaccine, Reuters reported the company as saying.
Biological E is also developing a drug substance used in Johnson & Johnson’s COVID-19 vaccine candidate, which is currently in early to mid-stage trials, the report added.
Other Indian companies in pre-clinical trials
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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