India is currently witnessing a downward trend in its daily COVID-19 infections and has recorded 7.2 million recoveries; has ~610,000 active cases as of October 2020. However, the upcoming festive season is likely to become a major concern.
India is the largest vaccine producer worldwide and accounts for >60% vaccines supplied to UNICEF. As the pandemic is showing no signs of abatement, numerous Indian companies are continuing their efforts to develop a vaccine and testing its safety and immunogenicity towards the Indian population, in the hope of aiding a return of normalcy into daily life. To support the COVID-19 vaccine development initiative, at present, there are 30 potential COVID-19 vaccine candidates in development, with three being in the advanced trial stages in India.
The Indian government has been continuously taking prompt preventive measures such as the unprecedented national lockdown, soon after the threat of COVID-19 spreading in India was realised. Moreover, it also undertook numerous affirmative regulatory steps and initiatives to ease out the regulatory processes required to develop the vaccine. In the beginning, in March 2020, the Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) came together to set up a rapid regulatory framework to fast track the regulatory approvals. This move was meticulously undertaken to offer accessibility to an accelerated approval system for clinical trials of a vaccine and import or manufacture a vaccine in order to sell and distribute or test. For approval purposes, the Review Committee on Genetic Manipulation (RCGM) and Central Drugs Standard Control Organisation (CDSCO) constituted an empowered committee, which could undertake review and examination of applications on a prioritised basis.
The Drug Controller General of India (DCGI) formulated draft guidelines on the regulatory requirements to licensure COVID-19 vaccines in India. As of September 2020, the Central Drugs Standard Control Organisation (CDSCO) granted test licence permission to manufacture COVID-19 vaccine for preclinical testing, examination and analysis to the following manufacturers in India:
- Serum Institute of India Pvt. Ltd., Pune
- Cadila Healthcare Ltd., Ahmadabad
- Bharat Biotech International Ltd., Hyderabad
- Biological E Ltd., Hyderabad
- Reliance Life Sciences Pvt. Ltd., Mumbai
- Aurbindo Pharma Limited, Hyderabad
- Gennova Biopharmaceuticals Limited, Pune
Currently, India is now at the forefront to develop and manufacture a COVID-19 vaccine with three front runners. The Serum Institute of India, along with the UK’s AstraZeneca, plans to mass produce the 'Covishield' vaccine developed by the University of Oxford. The other vaccines in the development process are 'Covaxin' and 'ZyCoV-D' that are being developed by domestic pharma companies, Bharat Biotech and Zydus Cadila, respectively.
In a bid to make information readily available and more transparent about the COVID-19 vaccines, the government launched a vaccine portal and national clinical registry for Coronavirus vaccine development in India on September 28, 2020. Developed by the Indian Council of Medical Research (ICMR), the portal provides useful and important information related to vaccine development and ongoing clinical trials within local and global perspective.
COVID-19 Vaccines Under Trials in India
The Serum Institute of India (SII) and Indian Council of Medical Research are jointly conducting a Phase II/III, observer-blind, randomised and controlled study to determine the safety and immunogenicity of Covishield (COVID-19 Vaccine).
Covaxin received approval from Drug Controller General of India (DCGI) for Phase I & II human clinical trials and an adaptive, seamless phase I, followed by phase II randomised, double blind, multicenter study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152).
Zydus Cadila, a pharmaceutical company, focussed on discovering and developing NCEs (New Chemical Entities), Novel Biologicals, Biosimilars and Vaccines, introduced ZyCoV-D, a plasmid DNA vaccine to prevent COVID-19. ZyCoV-D was found to be safe and well-tolerated in the Phase I clinical trials. The company commenced its Phase II clinical trials in August 2020 and is expecting trial results by November 2020.
The desire to break free from COVID-19, accompanied by the government support, paved way for at least three vaccines, of which Covishield is already in Phase III. As of now, the world is eyeing India to deliver the need of the hour — an efficacious and safe vaccine to fight COVID-19 and help return the world back to normalcy.
As per Union Health Minister, Mr. Harsh Vardhan, the country can expect vaccine for the novel coronavirus from maybe more than one source by early next year. Also, the government has formed a group of experts, under NITI Aayog, to formulate strategies on how to roll out the distribution of the vaccine in the country. The government is creating human resource capacities for administration, while the cold chain operators across the country have begun enhancing their logistics network to ensure optimum storage temperatures and capacity to manage safe delivery of vaccines to a population of more than 1.3 billion people. Post the successful development of COVID-19 vaccine, a huge business potential for cold chain and logistics operators could emerge so as to fulfill the domestic need and export.