In early July, two new vaccines against SARS-CoV-2 were added to the list of 15 candidate products currently being tested on humans. These are Covaxin and ZyCov-D, respectively developed by the Indian pharmaceutical companies Bharat Biotech and Zyd us Cadila. The director of the Indian Council for Medical Research has even announced that Covaxin could be made available from August 15.
With four other vaccines in the preclinical phase, India has therefore also returned to the forefront of the vaccine race. Some commentators have however called for distrust of the announcement effects, noting that August 15 is also Independence Day, the date on which the Prime Minister must speak on the successes of his government, a difficult task while the confinement of the country caused a humanitarian disaster and did not slow down an epidemic which officially caused 24,000 deaths on July 15.
The specialists, sceptical about this one month delay, also recalled the danger of sending clinical trials, critics immediately joined by the director of the Serum Institute of India. The Indian company is expected to produce the Anglo-Swedish AstraZeneca vaccine, which has already entered phase 3 of its clinical trials, and which is scheduled to launch in 6 months.
If a locally developed vaccine is not certain, it is nevertheless very likely that the Indian pharmaceutical industry will play a major role in the development of global immunity to SARS-CoV-2. But what will it be?
Limited pharmaceutical R&D
While 165 vaccines against SARS-CoV-2 were in development as of July 11, 2020, only 6 of them were initiated by companies based in India. It is not much when you know that India has no less than 334 companies with a turnover of more than 50 million euros according to data from the Center for Monitoring Indian Economy of 2016.
But developing a new molecule can cost several billion euros, investments that only a handful of Indian pharmaceutical companies can make. A dozen firms, therefore, invest in research and development (R&D) which peaks at 2% of their total expenditure, when the largest foreign multinationals typically spend between 8 and 15% per year.
Although they participate little in pharmaceutical innovation, Indian companies have historically distinguished themselves by their ability to absorb the discoveries of their foreign competitors, in particular through merger and acquisition strategies. It is for example through its new American subsidiary Profectus BioSciences Inc., acquired in 2019, that the Indian firm Aurobindo Pharma entered the preclinical testing phase for its vaccine against SARS-CoV-2, VesiculoVax.
A huge production capacity
In fact, Indian R&D has historically stood out for its ability to reduce the cost of drugs. Until 2005, the pharmaceutical patent being placed on the processes and not on the products, Indian companies perfected the art of copying patented medicines by simply modifying the manufacturing process.
Thus, Indian companies are now able to massively produce drugs at manufacturing costs on average 50% lower than those in high-income countries. The firm Bharat Biotech has marketed for example since 2015 a vaccine against Rotavirus, a highly contagious virus causing inflammation of the stomach and intestines, at less than one euro per dose as part of the immunization program of the World Health Organization.
Faced with this pressure on prices, a large part of multinational pharmaceutical companies, therefore, subcontract their production to Indian units, which were not less than 5099 in 2016 according to the Central Statistics Office.
The AstraZeneca firm behind the promising ChAdOx1 developed with researchers from the University of Oxford, which recently set up an agreement with the firm Serum Institute of India for the production of a billion bottles. The vaccine, tested on rhesus mice and monkeys, has demonstrated its ability to induce an immune response but has yet to prove itself in humans.
Expertise in the vaccine segment
The director of the Serum Institute has already announced that vaccine production has started at its two factories located in the Pune region of western India. Pending the construction of “the largest Covid-19 vaccine factory in the world”, as he explains to the daily Ouest-France, the production of certain products has been entrusted to other local companies.
The company is already the largest vaccine producer by volume: it produces 1.5 billion doses per year and has established itself over the years as the main supplier to UNICEF and the sole supplier of the vaccine against the disease.