COVID-19 VACCINE Candidates in India – Most Recent Update

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Dr. Prangya P.Tripathy, PhD, Neucrad Health Desk, August 5, 2020

India has recorded single day increase of 52,972 in Covid-19 cases, and total tally of 1,861,821 and total death of 39,044 by 3^rd  August, 2020. With herd immunity in question till date, vaccine is the only hope for the people now. Speaking on the issue in an online symposium organized by the Indian Council of Medical Research, Dr Anthony Fauci, one of world’s leading experts on infectious diseases, and Director of the National Institute of Allergy and Infectious Diseases in the United States, said India’s private sector will play a very important role as the world’s leading manufacturer of vaccines.

At least 30 different Indian companies are in the pipeline to produce the vaccines against Covid-19. The frontrunners are three Indian companies that have begun testing the vaccines for COVID-19. In addition, more than a dozen Indian firms in partnership with other Institutes and companies both in India and abroad are engaged to bring a working vaccine against the SARS-CoV-2 coronavirus into global markets. Let us have a look about the progress of different vaccine candidates from India till today.

A. COVAXIN by Bharat Biotech International Limited (BBIL)

Hyderabad-based Bharat Biotech International Limited (BBIL), in collaboration with ICMR (Indian council of Medical Research) and National Institute of Virology (NIV), Pune developed COVAXIN (BBV152), the first vaccine to get regulatory approvals for clinical trials in India. An inactive version of the virus is utilized in the vaccine to induce antibody production in the host body. With approval from the Drug Controller General of India (DCGI) the company has started Phase I and Phase II of the clinical trials from July, 2020. Twelve medical institutes across the country were notified, including AIIMS Patna and Delhi. To test safety and neutralizing antibodies of the vaccine the company has started recruiting volunteers for Phase I trials in 375 healthy volunteers as of 13 July. Further, based on the volunteer response in Phase I trial, a multicentre, randomized, double-blind Phase II trial with 750 volunteers has been proposed.

In another development, a recombinant deactivated rabies virus vaccine containing the spike protein against SARS-CoV-2 is under development by the company in collaboration with Thomas Jefferson University. The possible clinical trial will begin by December, 2020 with the support from Department of Biotechnology, Government of India. Bharat Biotech is aiming to enter human trials with the vaccine by December 2020.

B. Zydus Cadila’s ZyCoV-D

Ahmedabad-based pharma company Zydus Cadila has developed a novel vaccine ZyCOV-D in July, 2020 after extensive research in coordination with medical laboratories in the USA and Europe. A strong immune response was observed in multiple animal species in preclinical trials including rabbits, guinea pigs, rats and mice against ZyCOV-D. It is a DNA plasmid vaccine. Further supported by the Department of Biotechnology (DBT), the company has started recruiting 1,048 volunteers for its phase I and phase II clinical trials from 13 July, 2020. The company is optimistic for completing phase I/II study at the earliest and is trying to make it available for use by March next year, said Zydus CEO Pankaj Patel.

The company is also working with a second measles vector vaccine candidate for COVID-19 and is currently in pre-clinical trials.

C. Serum Institute of India (SII)

At least for three vaccine candidates Serum Institute of India (SII) is optimistic.

1. Oxford-AstraZeneca vaccine (AZD1222) 

The British-Swedish pharma major AstraZeneca along with the University of Oxford is recently involved in the development of the adenovirus vector vaccine. The vaccine prototype is currently in phase III of testing. The company has tied up with Pune based Serum Institute of India (SII) to mass-produce the vaccine once the company gets required approvals and licensing from medical boards. Serum Institute has also said it will begin the testing for the Oxford-AstraZeneca vaccine (AZD1222) candidate in India soon. It is expected by the company to receive a revised version of the protocol by the Indian regulator (CDSCO) in a few days of time. The SII announced to manufacture a billion doses of the vaccine after seeking the required approvals, As per latest update, Serum Institute of India has received approval from the Drugs Controller General of India (DCGI) to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in India. The company has received an approval from India’s apex clinical trial regulation body (DCGI) with a revised proposal to start human trials (Phase II and Phase III) in India for the Covid-19 vaccine candidate AZD1222. According to the revised proposal, over 1,600 people will participate in the trials in 20 selected cities across India.

2. Recombinant BCG vaccine (VPM1002)

A randomized, double-blind study of a recombinant BCG vaccine (VPM1002) for severe cases of coronavirus infection is carried out by Serum Institute of India. The vaccine is a further development of the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine still widely used to treat tuberculosis. An ongoing Phase 3 trial in 5,946 volunteers for the same is going on. Serum Institute is testing whether the vaccine reduces the severity of COVID-19 in high-risk patients.

3. Live-Attenuated Covid-19 Vaccine CDX-005

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.

D. Panacea Biotech

Panacea Biotech, a Delhi based company along with US-based Refana has entered into a Joint Venture partnership to develop, manufacture and distribute a COVID-19 vaccine candidate globally by 2021. It is working on an inactivated SARS-CoV-2 vaccine, and is currently in animal pre-clinical trials. With the target of 500 million doses in 2021 and one billion doses of its vaccine candidate by 2022, the company is optimistic to enter into human clinical trials soon in India. 

E. Indian Immunological

Indian Immunological Limited, Hyderabad and Australia’s Griffith University entered in a partnership to develop a potential COVID-19 vaccine candidate that could provide long-lasting protection with a single dose. The vaccine model makes use of an innovative codon-deoptimization technology and still in its nascent stage which directly targets the cells infected by SARS-COV-2. As per WHO’s vaccine tracker by 31st July, the vaccine development is currently in pre-clinical stages. The company intends to take over live attenuated vaccine strain once developed,

F. Mynvax

Mynvax is an Indian Institute of Science, Bangalore based start-up and in a process of development of a series of recombinant subunit protein vaccines for SARS-CoV2 and has received funding and support from the Bill and Melinda Gates Foundation. 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.” To scale-up and manufacture successful candidates Mynvax has also applied for Rs 15 crores funding from the Biotechnology Industry Research Assistance Council (BIRAC), India.   

Other Indian companies in pre-clinical trials

1. Biological E from Hyderabad is developing a protein subunit vaccine using the part of the SARS-COV-2 virus’ spike protein and has also been backed by the Bill and Melinda Gates Foundation. The vaccine candidate is in pre-clinical trials.
2. Aurobindo Pharma based in Hyderabad is presently conducting pre-clinical tests for its replicating viral vector vaccine against SARS-CoV-2.
3. 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.
4. Hester Biosciences, Ahmedabad-based companyin collaboration with IIT Guwahati is developing a vaccine against COVID-19 using a recombinant avian paramyxovirus vector. It is the second largest poultry manufacturer in India, this will be the company’s first venture into human vaccines.
5. Neuberg Diagnostics, an Ahmedabad based pathology lab under Neuberg Diagnostics, is in the process of developing a COVID-19 recombinant vaccines in partnership with Gujarat Biotechnology Research Centre (GBRC).

References

1. https://www.firstpost.com/health/serum-to-apply-for-licence-to-manufacture-oxford-vaccine-in-a-week-says-ceo-adar-poonawalla-8621661.html
2. https://www.livemint.com/news/world/oxford-covid-19-vaccine-shows-positive-result-in-early-trials-11595243287159.html.
3. https://zyduscadila.com/research
4. https://www.bharatbiotech.com/biohib.html
5. https://www.firstpost.com/india/emerging-landscape-of-covid-19-vaccines-in-india-as-of-31-july-bharat-biotech-serum-institute-zydus-at-the-helm-8660171.html
6. https://www.firstpost.com/india/serum-institute-gets-dcgi-nod-to-conduct-phase-2-3-human-trials-of-oxford-vaccine-in-1600-healthy-volunteers-in-india-8666941.html