How much vaccines can India make? And the catch...

As coronavirus cases continue to rise in the country, the focus has  shifted to vaccination. India has administered over 10.45 crore doses of COVID-19 vaccines cumulatively as of Monday morning. But in the clamour against vaccine shortage, the question is what is the total vaccine production capacity and how many COVID-19 vaccines can India produce?

The Department of Biotechnology had recently informed the Parliamentary Standing Committee on Science and Technology, Environment, Forests and Climate Change that the estimated manufacturing capacity of Covishield is 70-100 million doses every month, while Covaxin has a planned production capacity of 12.5 million a month (150 million doses a year). However, neither is producing to full capacity as vaccine makers say they are not earning enough to plough back into capacity enhancement. Sources say, Centre was initially procuring one dose of Covishield for Rs 210, inclusive of taxes, which has now been brought down to Rs 150 per dose, exclusive of taxes. In private hospitals, the price to consumer has been capped at Rs 250 per dose, leaving approximately Rs 100 for the hospital.

Recently in an interview, Poonawalla had sought a grant of Rs 3,000 crore from the government to ramp up Covishield production beyond 100 million doses per month, which SII will reach by the end of May. As per reports, vaccine makers, including Biological E, Gennova and SII, have sought support from the Department of Biotechnology to avail from the Rs 900-crore Covid Suraksha fund, set up by the Central government, to accelerate their vaccine programme. Besides, Bharat Biotech has also sought Rs 150 crore -- Rs 75 crore each for its facilities at Hyderabad and Bengaluru.

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In January, India had given emergency use authorisation to two COVID-19 vaccines -- Covishield, manufactured by the Serum Institute of India (SII), and Covaxin, which is being manufactured by Bharat Biotech. Bharat Biotech has three manufacturing facilities in Hyderabad and one in Bengaluru. The company is in the process of expanding its manufacturing capacities in Hyderabad by two-fold and in Bengaluru by five-fold.

Besides, SII, the much larger producer compared to Bharat Biotech, is upscaling its total vaccine manufacturing capacity from 1.6 billion doses per year currently to over 2.3 billion doses of vaccines annually. It will also increase its Covishield manufacturing capacity to 100 million doses per month from the current 50-60 million doses, SII CEO Adar Poonawalla told BusinessToday.In earlier. Covishield is licensed from Oxford University-AstraZeneca. "Once completed, between SII and SILS (Serum Institute Life Sciences), we will have a capacity to manufacture over 2.3 billion doses of COVID-19 vaccines, provided there is demand and requirement," he said.

Meanwhile, on Monday, the Subject Expert Committee of the Drugs Controller General of India granted approval to Russia's coronavirus vaccine Sputnik-V for restricted use in India, as per sources within the drug regulator's office. However, an official statement is awaited on the issue.

In September 2020, Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V, and for its distribution rights in India. Besides Dr Reddy's, the RDIF has partnered with many Indian pharma companies, including Panacea Biotec, Stelis Biopharma, Gland Pharma and Virchow Biotech Private Limited, for production of Sputnik V. In total, plans are firmed up for producing 850 million doses of Sputnik V per year.

India also can expect to get five more COVID-19 vaccines by the end of the third quarter in 2021. However, it needs to be remembered that bringing a vaccine to the market is a long drawn process. From research to clinical trials to regulatory approvals, it might take months, if not years, to bring the vaccine to the market, even with expedited approvals. Besides, the companies will also need a few months to ramp up their manufacturing capacities.

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Among the COVID-19 vaccine undergoing trials, Ahmedabad-based Zydus Cadila's ZyCov-D is in phase 3 trials. The company has created an in-house manufacturing capacity of 100 million doses per year and has also roped in a contract manufacturer for additional capacity of about 150 million doses per year.

Besides, Hyderabad-based Biological E has signed a contract-manufacturing deal for producing 60 crore doses of Johnson & Johnson's COVID-19 vaccine per year. The single-shot vaccine has already been approved in the US and the company is reportedly preparing to start its clinical trials in India.

Bharat Biotech is also conducting trials for its intranasal COVID-19 vaccine. The company's chairman Krishna Ella had earlier said that if the government can develop a protocol for all phases of clinical trials, the company can bring the vaccine to market by June 2021. "The production is very easy. The facility is in place already. It is a vector based vaccine. If successful, I can make more than 1 billion doses," he said.

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India also has additional vaccine manufacturing capabilities of other companies whose own COVID-19 vaccines are currently far away from launch. Among such companies, Aurobindo Pharma has a manufacturing capacity of 220 million doses per year and is increasing it to 480 million doses by June 2021.

Cumulatively, Indian vaccine manufacturers, including SII, Bharat Biotech, Panacea Biotech, Sanofis Shanta Biotech, Biological E, Hester Biosciences and Zydus Cadila, have an installed capacity to manufacture 8.2 billion doses of different vaccines per year. If required, this capacity can be tweaked to manufacture COVID-19 vaccines. Besides vaccinating every citizen of the country, it can be used to supply vaccines to other countries of the world.

Considering the rising cases, India reported over 1.68 lakh new cases in the preceding 24 hours as on Monday morning, the country will need to quickly step up vaccination. The funding from government can go a long way in helping vaccine makers increase their production and respond to the challenge thrown by the pandemic, by not only manufacturing for India but also for the entire world.

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