India’s role in COVID-19 vaccine

Indian manufacturers have the ability to produce vaccines and pharmaceutical drugs at the lowest costs world-wide, says Nitya Nand Deepak

COVID-19 vaccine, Pharmaceuticals and vaccine hub, Bharat Serums & Vaccines Limited, WHO, FDA, Zydus Cadila, Bharat Biotech India

In early July, India slid into the third spot for highest COVID-19 cases worldwide and the pressing need for mass vaccination assumed the centre-stage. As population density and vast geographies continue to pose issues in controlling the spread of the coronavirus outbreak, the health experts debate the unfolding of community spread of COVID-19. India’s medical research institutes and pharmaceutical manufacturing companies have been rapidly expanding their already voluminous production capacities and accelerating vaccine development in response to the outbreak. With these capabilities India is poised to be a key global player in effectively countering the pandemic through production and distribution of vaccinations.

Over the last decade, India has emerged as a global pharmaceuticals and vaccine hub. Globally, it is the one of the largest suppliers of generic medicines, occupying 20% share of global supplies, ranking third in terms of proportion and  tenth rank in terms of value. Outside of the US, India has the largest number of FDA compliant pharmaceutical plants and has nearly 1400 WHO approved pharmaceutical manufacturing units with latest technologies; the country houses over 10,500 manufacturing facilities operating under 3,000 innovative pharmaceutical companies.

According to the latest report by the IMARC Group, India’s vaccine market in 2019 totalled Rs 94 billion and was projected to reach Rs 252 billion by 2025, with a CAGR of 17.8% during this period. The increasing governmental and non-governmental funding and scaling up of production facilities in the recent months may account for further unprecedented and exponential growth in these figures. India exports vaccinations to over 150 countries over the world supplying 62% of global demand for vaccines. Of the total vaccine production in India, it is estimated that about 70% of the manufactured vaccines are exported while 30% cater to domestic consumption. Sixty percent of vaccines supplied to UNICEF are reportedly produced by Indian manufacturers

Leading this growth is Pune-based Serum Institute of India, world’s largest vaccine manufacturer in terms of number of doses produced and sold globally. In early April, the Institute tied up with AstraZeneca and University of Oxford for their vaccine candidate ‘ChAdOx1 nCoV-19’, as one of the seven selected global manufacturing units for this candidate. Considering the recent announcements by the University of Oxford, confirming the success of their candidate in Phase I/II trials, this partnership, which was built on pure anticipation of success on the part of Serum Institute, holds value. As the candidate begins phase III of human trials, results indicate that it effectively elicits antibody response without causing any adverse effects.

The company aims to manufacture 2-3 million doses and begin human trials of this vaccine in India by the end of August 2020. Serum Institute will expend approximately 200 million USD to manufacture 300 million doses of the vaccine before Oxford completes all clinical trials and approvals, a well calculated risk. Eventually, Serum Institute is to supply one billion doses for low-and-middle-Income countries through the partnership with AstraZeneca and manufacture about 50% of the doses produced. The Institute is also believed to be in discussions for tying up for undertaking production for two other viable vaccine candidates.

Additionally, two of India’s indigenous vaccine candidates are also seeing progress and promise. ‘Covaxin’ developed by Hyderabad-based Bharat Biotech India in collaboration with Indian Council on Medical Research, and ‘ZyCoV-D’ developed by Zydus Cadilla have been approved by India’s Drug Controller General to commence human trials, after successfully completing preclinical trials. Accordingly, Phase I/II trials are reportedly initiated for these vaccine candidates, with 1000 volunteers enrolled for the process on a fast-track basis. Covaxin was the first Indian candidate to be given approval for human testing and has also been recognised by the WHO in its repository of vaccines under clinical trials. Furthermore, there are at least four more Indian companies are in preclinical stages of COVID-19 vaccine research. These include companies like Biological E, Indian Immunological, Mynvax and Panacea Biotec. According to the Secretary of the Department of Biotechnology, a total of 14 vaccine candidates in various nascent stages look promising.

Complementing the large production capacity and R&D capabilities, Indian manufacturers have the ability to produce vaccines and pharmaceutical drugs at the lowest costs world-wide. The cost of pharmaceuticals manufacturing in India is an estimated 33% lower than that in the US. In keeping with these cost efficiencies, the Serum Institute of India estimates that their manufactured vaccine would be available at a cost of Rs 1000 (USD 13.36) per dose. These synergies among cost, production and technology, hold immense potential in accelerating India’s role in the countering the coronavirus pandemic both domestically and globally. These developments have to be accompanied with regulations, approvals, investment and government policies around the innovations - thereby speeding and strengthening the trajectory.

Nitya Nand Deepa is India Country Director with  ImmunifyMe.