Over a dozen Indian companies are working with other firms and institutes to bring a preventive vaccine to the world market by 2021.
Publisher’s Note: This story was originally published July 31st and updated August 14th to include updates on candidates from Bharat Biotech, Zydus Cadila, Biological E, and Serum Institute.
Two Indian companies are currently in phase 1/2 adaptive human trials with a potential COVID-19 vaccine in volunteers. However, there are over a dozen Indian companies that, in partnership with companies and institutes – both in India and overseas – are bringing a working vaccine against the SARS-CoV-2 coronavirus to the market.
Bharat Biotech has partnered with the National Institute of Virology completed phase 1 studies in humans from their COVAXIN candidate in most of the 12 selected centers from August 14th. The results of the preliminary study suggest that the vaccine is safe. The main examiners conduct the studies told the business hours.
Now the 12 study centers have recruited volunteers for phase 2 studies that will test the effectiveness of the vaccine to determine an immune response against the coronavirus. Phase 2 should begin in the first week of September.
Upon completion of the Phase 1 studies, Bharat Biotech intends to continue a multicenter, randomized, double-blind Phase 2 study with 750 volunteers to determine how safe and effective the BBC152 vaccine is in a larger group.
The preliminary Phase 1 studies were carried out to test safety and to check whether Covaxin (BBV152) can produce neutralizing antibodies against SARS-CoV-2. 375 healthy volunteers were part of the studies, which began in mid-July in 12 centers across India.
In addition to Covaxin, Bharat Biotech is developing one in collaboration with Thomas Jefferson University recombinant deactivated rabies virus with the Spike protein against SARS-CoV-2. With the support of the Department of Biotechnology, Bharat Biotech aims to conduct trials with this second vaccine candidate in humans by December 2020.
Bharat Biotech has also partnered with the University of Wisconsin-Madison and FluGen to develop a vaccine against SARS-CoV-2 using one Influenza virus vector. The candidate is currently in pre-clinical animal testing according to an update by WHO on August 13th.
Serum Institute of India
The Serum Institute of India is currently conducting a randomized, double-blind study of a recombinant BCG vaccine (VPM1002) for severe cases of coronavirus infections. This vaccine is a further development of the popular 100-year-old vaccine against Bacillus Calmette-Guérin (BCG), which is still widely used in tuberculosis prevention worldwide.
In the current Phase 3 studies The Serum Institute is testing 5,946 volunteers to see if the vaccine will reduce the severity of COVID-19 in high-risk patients.
“We are very pleased to be working with DBT-BIRAC on this study and look forward to the positive results of the study, which should be available before the end of this year,” said Adar Poonawalla, owner and CEO of SII say of the Press information office.
The Serum Institute has partnered with AstraZeneca and Oxford University to create the Oxford COVID-19 in India. On August 10, the Serum Institute announced The vaccine costs Rs 225 per dose in India.
After this The promising results of the first trials at Oxford were published in mid-July, Announced serum manufacture one billion doses of the Oxford-AstraZeneca experimental vaccine after obtaining the necessary permits.
The vaccine is currently in phase 3 trials in various countries and serum is scheduled to begin testing for the vaccine Oxford AstraZeneca Vaccine (AZD1222) Candidate in India soon, according to regulatory requirements. It received one No-go from Indian regulators for its trial protocolAfter that, the revised version was accepted by the Indian regulatory authority (CDSCO) a few days later.
The Serum Institute is developing a live attenuated COVID-19 vaccine candidate in collaboration with Codagenix from the USA CDX-005, which is in pre-clinical studies from the beginning of August 2020.
SII announced a new one Partnership with the global vaccine alliance GAVI and the Bill & Melinda Gates Foundation to expedite 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, supported by the Department of Biotechnology (DBT), has successfully passed a security test (phase 1) from his DNA Plasmid ZyCoV-D vaccine candidate among 1,048 volunteers on August 5, 2020. To Phase 1/2 adaptive study to test the safe dosage and effectiveness of the vaccine was launched on August 6th in over 1000 healthy adult volunteers.
Zydus said it was hopeful to complete Phase 2 trials for ZyCoV-D in a September through October interview With CNBC-TV18. In the pre-clinical phase, ZyCoV-D produced a strong immune response in several animal species including mice, rats, guinea pigs and rabbits and raised no safety concerns.
One second Measles vector vaccine Zydus’s candidate for COVID-19 is currently in preclinical studies.
Panacea Biotec has entered into a joint venture partnership with Refana of the USA to develop, manufacture and distribute a COVID-19 vaccine candidate worldwide by next year. The Ireland-based joint venture is working on one inactivated SARS-CoV-2 vaccine, Adding in one Interview with Reuters that the vaccine is currently in the animal preclinical studiesPhase 1 human trials are not expected to begin until after September 2020.
It has set a goal of producing 500 million cans in 2021 and 2021 a billion cans of the vaccine candidate in 2022, according to the report.
Indian Immunologicals and Griffith University, Australia, have partnered to develop a potential COVID-19 vaccine candidate that “long-lasting protection with a single dose,“According to an April press release.
The company intends to take over live attenuated vaccine Strain once developed and gradually conduct clinical trials under Indian regulators. Vaccine development is currently at a pre-clinical stage according to WHO information Vaccine tracker Status: August 13th.
Mynvax, a startup founded by the Indian Institute of Science, has funding and support from Bill and Melinda Gates Foundation to develop a number of Recombinant Subunit Vaccines for SARS-CoV-2. The vaccine is primarily aimed at the groups most at risk for COVID-19 (health workers, the elderly and people with comorbid conditions).
Mynvax said in a public update in May These selection and preclinical studies have been completed for many candidates and more will be reviewed “over the next few months.” Mynvax has also applied for Rs.15 billion funding from Biotechnology Industry Research Assistance Council (BIRAC) to grow and manufacture successful candidates.
Biological E, another Indian drug manufacturer owned by the Bill and Melinda Gates Foundationdeveloped a Protein subunit vaccine With Part of the SARS-COV-2 virus spike protein. The vaccine candidate is in pre-clinical studies As of August 13, 2020.
Biological E has entered into a licensing agreement with Baylor College of Medicine in Houston to develop a COVID-19 vaccine. Reuters reported the company as a saying.
Biological E is also developing a drug substance to be used in Johnson & Johnson’s COVID-19 vaccine candidate, which is currently in early to mid-level trials report added.
Other Indian companies in preclinical studies
Aurobindo Pharma based in Hyderabad currently also conducts pre-clinical testing for its replicating viral vector vaccine against SARS-CoV-2.
Premas Biotech based in Gurugram According to reports Working on a triple antigen vaccine candidate and has successfully identified three antigens that can be used to develop independent recombinant vaccine candidates against SARS-CoV-2.
Based in Ahmedabad Hester Biosciences in collaboration with IIT Guwahati is According to reports Development of a vaccine against COVID-19 using a recombinant avian paramyxovirus vector. This is primarily an animal health company and the second largest poultry vaccine maker. This will be the company’s first foray into human vaccines.
Gujarat Biotechnology Research Center (GBRC) has partner With Neuberg Supratech, an Ahmedabad-based pathology laboratory under Neuberg Diagnostics to develop recombinant COVID-19 vaccines and diagnostics.
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