India registered its first COVID-19 case on 30-January-2020 in Kerala. The cases since then are on a continuous rise. The Government of India in order to contain the spread of novel coronavirus rolled out several guidelines and precautionary measures. The situation worldwide was so serious that the whole nation was put under lockdown from 25 March 2020, all the flights were cancelled, public transportation was ceased, companies were shut and markets were closed down. However, the government ensured free ration services and delivery of essential commodities at the doorstep. Moreover, for seamless tracking of the COVID-19 new cases, the app called Arogya setu was launched, which gave an individual to keep a tab on oneself.
However, the restrictions and lockdowns resulted in the crashing down of the economic growth of the country. In a tough dilemma, to regain the plummeted growth back, the government lifted the lockdown and that added to increasing numbers of the India COVID-19 cases. While there were only around 97,008 active cases on June-1-2020. Today (i.e on 29 July 2020) the tally has crossed the figure of 1.53 Million with more than 30 thousand casualties. For the past few days, the average for daily new cases has crossed the 40k mark. India, at present, is the third worst-hit country in the world, after the United States and Brazil.
Since the lockdown proved to be one of the temporary solutions to control the virus, the lockdowns were lifted to resume the routine life of people with precautions such as masks, sanitizers, and social distancing; however the race to find a cure – therapeutic and preemptive – continues.
Today the whole world is in a search for an effective vaccine candidate against SARS-CoV-2. The vaccine appears to be the only solution to prevent coronavirus. Several pharma and biotech companies are developing and manufacturing safe and effective vaccines to fight coronavirus. Globally, around 150 vaccine development projects are going on for Covid-19, some of the most promising COVID-19 vaccine candidates in the pipeline at the global level includes Moderna (mRNA-1273), CanSino Biologics Inc (Ad5-nCoV), AstraZeneca/Oxford (ChAdOx1 nCoV-19 /AZD1222), Inovio Pharmaceuticals (INO-4800), Sinovac Life Sciences (CoronaVac) among others.
Similar is the case in Indian pharmaceutical industry. Looking at the gravity and seriousness of the situation, the government of India has launched the “Task Force on Repurposing of Drugs for COVID19” (TFORD-COVID19) program to reduce the Lab to Market Journey of drugs for Covid-19. The aim of TFORD-COVID19 is to keep track of the latest and continuously evolving information on drug candidates, and also to carry out an inter-disciplinary and inter-institutional assessment of drug candidates. A number of Indian pharma and biotech companies are working independently and in collaboration with other pharma and biotech players to develop covid-19 vaccine.
Currently, India has more than 25 companies invested in the COVID-19 vaccine development race. WHO is tracking vaccine development worldwide which are in different phases, similarly in India around seven leading companies working independently and in collaboration are in various Phases of clinical trials.
Some of the Indian companies with their vaccine in the different testing and clinical phases includes:
Bharat Biotech International Limited (BBIL), ICMR and NIV, Pune (COVAXIN)
Founded in 1996, Bharat Biotech Is one of the leading biotechnology companies in india. With over 160 patents under its name, Bharat Biotech is the leading front runner for Covid-19 vaccine in india.
Bharat Biotech International Limited (BBIL) is working in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune for COVAXIN which is the first indigenous Covid-19 vaccine candidate in india.
BBIL has received the approval of Drugs Controller General of India (DCGI) for conducting the Phase I & II Human Clinical Trials. The first part of Phase-1 trials commenced at PGIMS, Rohtak on July 17. Similarly, on 24 July, a 30 year old man in AIIMS Delhi was administered with the first dose of COVAXIN.
Serum Institute of India (SII) & AstraZeneca/ Oxford University
British-Swedish pharma company AstraZeneca in collaboration with Jenner Institute (Oxford University) is working on Covid-19 vaccine ChAdOx1 nCoV-19 /AZD1222. AstraZeneca and Oxford University have released encouraging results of Phase I/II results of the vaccine. Right now the vaccine is in phase III.
Serum Institute of India (SII), one of the leading vaccine manufacturers in the world has partnered with AstraZeneca-Oxford for manufacturing Covid-19 vaccine. SII is expected to conduct the human trials in India in the month of August. As per Adar Poonawalla, (CEO, SII), the Covid-19 vaccine is likely to get available by the end of the year. SII has spent over USD 100 million on manufacturing facilities to produce and supply around 1 billion doses of the COVID-19 vaccine. SII manufactured vaccines will be available in India and middle and low-income countries across the world after the successful completion of trials.
Zydus Cadila (ZyCoV-D)
Based in Ahmedabad, Zydus Cadila is one of the top most pharma companies in the Indian pharmaceutical industry. Zydus is working on Covid-19 vaccine ZyCoV-D. Zydus has started the human clinical trials of its plasmid DNA based vaccine, ZyCoV-D.
Earlier the company had successfully completed the preclinical trials and found ZyCoV-D to be immunogenic in multiple animal species at its Vaccine Technology Centre in Ahmedabad, India.
For ZyCoV-D Phase I/ II clinical trials Zydus is all set to enroll over 1000 subjects across multiple clinical study sites in India. To conduct clinical trials, the company has already manufactured clinical GMP batches of the vaccine candidate.
Founded in 2017 by Raghavan Varadarajan and Gautham Nadig, Mynvax is a Bengaluru based biotech startup, working in the development of indegenous experimental vaccines for the novel coronavirus (Covid-19). Mynvax is incubated at the Indian Institute of Science, Bengaluru and also backed by the Bill and Melinda Gates Foundation. Apart from Covid-19, the startup is also involved in the programs for recombinant vaccine for human influenza.
Till now the startup has developed several candidate immunogens and so far have completed initial animal trials. It is expecting to launch a safe and effective vaccine in about next 18 months. In order to scale the process of vaccine development, Mynvax had applied for Rs 15 crore funding from Biotechnology Industry Research Assistance Council (BIRAC).
Biological E Ltd.
Founded in 1953, Biological E is one of the first private sector biological products companies in India. It is involved in the manufacturing and supply of generic vaccines and therapeutics. It supplies vaccines to over 100 countries worldwide.
Biological E is one of the seven leading companies involved in the Covid-19 vaccine development in india. At the moment the vaccine candidate of Biological E is the preclinical stage.
Indian Immunologicals Limited & Griffith University (Australia)
The Hyderabad based Indian Immunologicals Limited (IIL) has formed a research collaboration agreement with Griffith University, Australia to develop vaccine candidates for Covid-19. The vaccine is based on codon-deoptimization technology which directly targets the cells infected by SARS-COV-2. The vaccine right now is in the Preclinical trials and studies stage.
Panacea Biotec & Refana Inc.
On 10-June-2020, Panacea Biotec, a Delhi-based biotechnology company, announced its collaboration with Refana Inc. USA to develop Covid-19 vaccine, through a Joint Venture company to be based in Ireland.
As per the agreement Panacea Biotec will be responsible for product development and commercial manufacturing, while the joint venture will undertake the clinical development and regulatory submissions across the world. Panacea Biotec is expecting to manufacture around 500 million doses of the COVID-19 candidate vaccine, and is also expecting to deliver 40 million doses by early next year. Further details regarding the clinical trials and study are expected to be available in upcoming weeks.
Although several pharmaceutical companies are developing and evaluating their candidates, it must not lose sight that vaccine development is a cumbersome and time-taking process. The continuous trials and studies are ongoing for the Covid-19 vaccine, but the time period for a safe and effective covid-19 vaccine may take more than the expected. Besides the fight against coronavirus India has several unique challenges as well. One of them is population density. Some of the major urban cities such as Delhi, Kolkata, Chennai, Mumbai, Ahmedabad, Bangalore have a very high population density. As per various data, these cities comprise the majority of cases and death reports as compared to the other parts of the country. Other major complexity is poor healthcare infrastructure and facilities. The healthcare delivery system before the covid-19 also was not that adequate, which has further been crippled by COVID-19.
The situation appears bleak, however, the rising recovery rate as recorded on 29-July stands at 64.5%, which is the highest among all the hit-countries worldwide, offers some relief.
Nevertheless, till the standard approved cure embraces the Indian pharmaceutical market, maintaining social distancing, following basic hand and respiratory hygiene seems to be the only options to control the spread of the virus.