India has modelled itself into a superpower when it comes to vaccines, in fact, the world over in some closed knowledgeable circles India is referred to as the pharmacy of the world. The knowledge of the same has come out in the open now thanks to the novel Coronavirus.
While developed countries like Canada are struggling to find vaccines in adequate numbers to vaccinate their citizens; India has gone on a unique diplomatic outreach hashtagged "Vaccine Maitri" (Vaccine friendship) where she is gifting smaller countries across the world with life-saving vaccines for safe vaccination of their citizens. This has generated a lot of goodwill for India and has actually helped the companies which are manufacturing vaccines improve their reputation too.
Here is a list of vaccines manufactured in India, while some have been designed elsewhere & licensed to be mass-manufactured here by pharma companies, some others are developed indigenously and manufactured.
The Oxford-Astrazeneca Covid19 Vaccine AZD1222 (Covishield)
Is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using the modified chimpanzee adenovirus ChAdOx1 as a vector, it is being licenced and mass-manufactured by Serum Institute of India Pvt Ltd a company based out of Pune, Maharashtra. It claims of 70+% efficacy and is one of the vaccines being used in India in the ongoing vaccination drive.
The NIV-ICMR-Bharat Biotech Covid19 Vaccine (Covaxin)
Is a Covid-19 vaccine developed in collaboration with the National Institute of Virology, ICMR and Bharat Biotech. They have used the fully inactivated Novel Coronavirus as the immunogenic agent in the vaccine. Theoretically, this is the most known tried and tested conventional way of making vaccines. This is one of the two vaccines being used in India for its vaccination drive. The problem which has been raised by many experts is the non-availability of efficacy data in the public domain (even now).
The above two vaccines have got emergency approval for usage by DGCI. Apart from the above, there are other drug manufacturing companies that have jumped into the fray to produce an effective vaccine against Covid19.
Here are the others we know:
The NVX-CoV2373 Covid19 Vaccine from Novovax
Novavax is developing NVX-CoV2373, a new vaccine for SARS-CoV-2, in partnership and funding from Coalition for Epidemic Preparedness Innovations (CEPI) and reportedly in a licencing arrangement with Serum Institute of India Pvt Ltd for manufacturing the same in India.
NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate made using Novavax's proprietary nanoparticle technology.
Novavax boasts of a patented saponin-based Matrix-M adjuvant that has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site & enhances antigen presentation to local lymph nodes, increasing immune response significantly thereby helping a vaccinated person's immune system make antibodies against the virus better compared to other methods of vaccine preparations.
Novavax identified NVX‑CoV2373 as its lead COVID-19 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. With 89% reported efficacy it is still in phase III trials and is expected to be launched soon.
The HGCO19 Covid19 Vaccine from Gennova
Gennova in collaboration with HDT Biotech Corporation, Seattle, USA has worked together to develop an mRNA vaccine since the first report of the SARS-CoV-2 genome was published. It used the highly efficacious mRNA methodology of manufacturing which is used in Moderna & Pfizer created vaccines.
Gennova boasts of a unique platform called 'LION delivery system' used for HGCO19 that has adjuvanting properties, enhanced storage stability, reduced adverse effects, improved permeability and bioavailability. Gennova claims that its technology platform will ensure the preparedness for any future pandemic or endemic stage that might follow (mutation in the virus, unvaccinated low-risk population, newborns, etc.).
Personally, I am waiting to see how this works out, it carries a lot of promise and is currently in phase II & has a long way to go before DGCI approvals &final utilization among our people.
The ZyCoV-D Covid19 Vaccine from Zydus Cadilla
ZyCoV-D is "India's first indigenously developed DNA vaccine candidate against Covid-19". The vaccine candidate is supported by the National Biopharma Mission (NBM) under the Biotechnology Industry Research AssistanceCouncil(BIRAC), aPSU under the Dept of Biotechnology.
ZyCov-D is being developed on a DNA platform using a safe non-replicating and non-integrating plasmid carrying the novel coronavirus gene. DNA platforms are known to have better vaccine stability and lower cold chain requirements, which would make it easier to store and transport to remote parts of the world.
DNA vaccines are complex; composed of bacterial plasmids with a gene encoding for the protein of interest a transcription promoter and terminator. Safe to say that although animal trials show good promise; data in human clinical trials of DNA vaccines has not been encouraging. This vaccine candidate is in phase III clinical trials so it would be prudent to wait for its published results before we pass a judgment on this.
THE BIO E Covid-19 Vaccine
Bio E's COVID-19 vaccine candidate is based on classical vaccine technology of a protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG1018.
This Covid19 RBD protein is expressed in yeast Pichia pastoris, and is similar to technology Bio E is employing for large-scale commercial production of Hep B vaccines. The Baylor College of Medicine constructs "RBD N1C1" was selected as the final vaccine antigen candidate on the basis of its manufacturability, due to the yields of protein antigen achieved, ease of process steps and favorable formulation aspects.
The combination of Alum with CpG with N1C1 antigen elicited a highly synergistic, balanced immune response in preclinical models. Four formulations with these components are currently being evaluated in Phase I/ II clinical study in India to select the final vaccine candidate to be tested in subsequent PhaseIII trials.
The Potential advantages of this vaccine candidate include scalability and thermostability, which makes it suitable for deployment at scale in low-resource settings.
This vaccine candidate has been able to get a lot of interest nationally & globally with CEPI, COVAX & DBT (India) funding the same. It is currently in phase II and will probably move on phase III soon. Awaiting more information on this candidate.
The UB-612 Covid-19 Vaccine
This UB-612 vaccine candidate developed by COVAXX is specifically designed to allow for the inclusion and presentation of multiple epitopes (multitopes) to elicit both B-cell and T-cell responses without enhancing COVID-19 disease.
UB-612 is designed to target a critical antigen from the Spike protein, the RBD, thought to be necessary for viral attachment to human cells, plus additional viral epitopes (from other viral structural proteins) designed to promote B-cell and CD8+ T-cell memory responses, says the company.
In December 2020 Covaxx entered into an agreement with Aurobindo Pharma India. Under the terms of the deal, Aurobindo Pharma will leverage its existing development, commercial and manufacturing infrastructure to develop, manufacture and sell COVAXX's UB-612 vaccine for India and the United Nations Children's Fund (UNICEF) agency. Currently in Phase I, we will be waiting to hear more from them soon.
The Bharat Biotech BBV154 Intra Nasal Covid-19 vaccine
Bharat Biotech as reported was seeking permission for phase I/II clinical trial of its Chimpanzee Adenovirus Vectored COVID-19 intranasal vaccine (BBV154), the SEC committee said the firm should generate safety and immunogenicity data in Phase-I clinical trial, with 75 subjects, in the proposed doses as per the protocol.
Bharat Biotech claims very good results in animal trials on their website. While their Covaxin, which is approved for use in clinical trial mode by the regulator is being developed in association with ICMR-National Institute of Virology, for the nasal vaccine candidate Bharat Biotech and Washington University School of Medicine in St. Louis had in September announced a licensing agreement. Although we do not have a lot of information on this vaccine candidate, I am looking forward to this eagerly.
Honorable mention: Sputnik V by Dr Reddys
This Covid-19 vaccine is developed by Gamaleya Institute Russia and being used for vaccination there. Dr Reddys has entered into a licensing and sale agreement for the same in India.
This is a long post to my liking however, I want the people of the world to recognize the fact that many companies of India backed by our government & the department of biotechnology are working to provide an everlasting solution to this pandemic that has derailed normal life as we know.
[Dr Jagadish Hiremath is a practicing doctor and a public health intellectual. He is also MD & CEO of ACE Healthcare which runs and manages hospitals in Bangalore. The views expressed in this article are the writer's own.]
