by Rajesh Kumar Sinha 30 November 2020
The Indian PM Modi has had a usually hectic but whirlwind tour recently to Ahmedabad, Hyderabad, and Pune. The visit was aimed at getting a personalised first-hand idea of the progress achieved towards the launch of the Covid-19 vaccine being worked on by Indian companies. The entire world is frantically searching for a vaccine against the Covid-19 virus. A lot of work has already been done in the UK, USA, Russia, Europe, China besides India.
In India, seven major pharma companies are working on the Covid-19 vaccine. Indian Immunological’s Limited, Mynvax, Panacea Biotech, Biological E are amongst the companies along with three others that were visited by PM Modi who are racing against time to create a Covid-19 vaccine. The three companies he visited are Zydus Cadila (Ahmedabad), Bharat Biotech (Hyderabad), and Serum Institute of India (Pune).
Zydus is working on ZyCoV-D and its Phase-II trials have been completed. It is working on a couple of versions of its vaccine and expects it to be available in the market by the end of March next year. The Pune-based Serum Institute of India has entered into an arrangement to produce, unspecified doses of Covishield, to be manufactured by AstraZeneca, in a tie-up with Jenner Institute of Oxford. Though there have been some reports of manufacturing errors, initial analysis has shown a 70 percent efficacy as per the clinical trials and Serum Institute expects the vaccine to be available in the market by April 2021.
Modi’s visit to Hyderabad-based Bharat Biotech has generated a lot of interest. Besides being involved in the R&D and manufacturing work and clinical trials on Covaxin, this indigenously worked vaccine is being made by the company in collaboration with the National Institute of Virology (Pune) and the Indian Council of Medical Research (ICMR). Available reports have indicated an efficacy rate of more than 60 percent in course of the first two stages of clinical trials while the third and final stage with 26,000 volunteers under the supervision of ICMR is underway.
This indigenous, inactivated vaccine has been made in a BSL-3 high containment facility at the company’s laboratory at Genome Valley near Hyderabad. Genome Valley was set up way back in 1999, covering an area of about 600 sqkms near Hyderabad. It was set up with a futuristic vision of a cluster for hi-tech research in existing and emerging disciplines of biomedical sciences. Broadly developed on the model of Silicon Valley of New Jersey, Genome Valley has evolved into an excellent centre for research on medicines, biosciences, biotechnology with R&D facilities, training, and manufacturing.
India’s Genome Valley has emerged as a systematically developed hub that houses over 150 leading pharmaceutical companies, from India and abroad. It has also been called as the Swiss Hub of India as the globally acclaimed Swiss MNCs Novartis, Ferring and Lonza have their facilities located within one km of each other. In addition, six of the world’s leading ten companies in the domain of pharmaceuticals to have their R&D centres based at Genome Valley.
Another reason for the Genome Valley to celebrate is that it houses three of India’s leading vaccine manufacturers, namely Indian Immunologicals, Biological E, and Bharat Biotech, the latter is the one which expects to come up with the Covid-19 vaccine, CoVaxin in the second quarter of 2021.
Set up by the Telangana State Industrial Infrastructure Corporation (TSIIC) in collaboration with the ICICI Group, this public-private partnership project has turned into a big success. That each year, about 2,00,000sqft of laboratory space is being added and more and more companies from various parts of the world are setting up their R&D set-ups at Genome Valley, speaks of its success.
One important positive for Genome Valley has been the establishment of the National Institute of Pharmaceutical Education and Research (NIPER), set up by the Government of India. It aims to act as the resource centre for human resource capacity building for the pharma industry besides enhancing industry-institutional linkages. Already about 10,000 personnel are involved in various manufacturing, quality control, R&D activities in various companies at the Genome Valley.
The Genome Valley near Hyderabad is South and South-East Asia’s largest R&D cluster that is home to some of the most celebrated global brands like Daiichi, Glaxo Smithkline, Novartis, DuPont, Sanzyme, Mylan, Chemo, Finoso Pharma, and many others. The Swiss MNC Ferring has already invested in a US$250 million R&D centre at Genome Valley. All top Indian pharmaceutical giants including AMRI, Alembic Research, Laurus Labs, Issar Pharma, Advanta, Biological E, Indian Immunologicals, Shantha Sanofi, Biomax Life Sciences have their presence at Genome Valley.
In spite of tremendous government and private efforts around the world, so far only two Covid-19 vaccines have been approved. Sputnik V and EpiVacCorona, both from Russia have received regulatory approvals. However, in the absence of Phase 3 clinical trials, significant concerns about their efficacy have been raised by the medical community. And in spite of huge initial publicity by China about its CoronaVac, information about its actual efficacy on volunteers in the Phase 3 trials is not forthcoming. In the US, work on various Covid vaccines like BNT 162, AZD 1222, mRNA 1273 all are in various stages of Phase 3 clinical trial.
India with a whopping 94 lakh Covid patients with active cases ranging from about 4 -4.6 lakhs only, has leveraged its manufacturing capacity to pre-order 600 million doses of the vaccine being worked on. Negotiations for another one billion doses with domestic and global manufacturers are underway. That makes India, second only to the US that has deals for 810 million doses while it negotiates for another 1.6 billion doses.
In the backdrop of such a situation, there lies a real possibility of an Indian vaccine, amongst the three which all are in the advanced trial stages, making history by becoming the first or the leading ones to come up with a successful vaccine in the next few months. The other Indian companies who also are part of the Covid-19 vaccine research like Panacea Biotech, Indian Immunologicals, Biological E, and Mynvax all have their R&D set-ups at Genome Valley. One never knows but history might be written when one of its proud owners could come up with a Covid-19 vaccine and that might well be the beginning of Genome Valley near Hyderabad replicating the success of Silicon Valley and becoming synonymous with the success of Indian and global pharmaceutical industry.