While the Indian government claims it has assessed the present requirement of vaccines and is working towards augmenting capacities, it is to be seen how many vaccine doses would be made available by May-June, as the country has plans to vaccinate 30 crore people by July in the first phase, say industry observers.
It may be difficult to bank alone on the Indian vaccines as the current plans mainly revolve around the Serum Institute's (SII) Covishield that is yet to get clearance and Bharat Biotech's Covaxin, they say. To vaccinate 30 crore people, the country will require minimum 60 crore doses.
So far, SII has made 5 crore doses of the Oxford University-AstraZeneca vaccine and is planning to make 10 crore doses of Covishield each month, starting next year. Though Serum has said India will be its first priority of supply, it will have to supply at least half its production to the Gavi Alliance-Bill Gates and Melinda Foundation for distribution in poor and developing 180-plus countries. They have funded in advance $300 million at risk to SII to make COVID-19 vaccines. Therefore, SII may be able to provide India only a maximum 30-40 crore doses by May end, calculates an industry expert.
The other priority for the government is to ensure a lion's share of production of India's own vaccine - Covaxin, developed by ICMR's National Institute of Virology in Pune and Hyderabad's Bharat Biotech. Now Bharat Biotech has a capacity to make 40-50 crore doses a year and realistically, the country can secure 20-25 crore doses by May-end, provided the company gets approval within a few weeks. Bharat Biotech's chairman and managing director Krishna Ella recently told Business Today that it has started stock-piling, but those are in small quantities. The third option is to book Russia's Sputnik vaccine, as Dr Reddy's Laboratories and Hetero Drugs have licensed to make 10 crore vaccine doses a year for the Indian market, but full-scale production is expected only after completion of the trials and approval, likely by March-end.
Similarly, rest of the vaccines under development are likely to come only by May-June or in the second half of 2021. The earliest one is likely to be another domestic vaccine, Zydus Cadila's Zycov D. It is yet to complete the final stage of clinical trials, and the vaccine is expected to be ready within two-three months. Now Zydus has set up capacity to make 15 crore doses a year and is likely to contract-manufacture a similar quantity. Aurobindo Pharma's vaccine facility with 40-45 crore doses a year capacity is going to be ready only by March-April and the vaccine launch is expected to happen only by May, if all goes well.
Hyderabad's Biological E has a manufacturing contract with Janssen Pharma of Johnson and Johnson, but at present there is no clarity on timelines of launching this vaccine and India securing its production. However, Biological E is developing a vaccine with Baylor College of the US, and this is likely to advance to final stages in a few months. Biological E has capacity to make 5-8 crore doses a month and also recently acquired a 16.5 crore doses per year capacity Indian facility of US based Akorn. Another biotech, Pune-based Gennova Pharmaceuticals can make 20 crore doses, but its vaccine trials will start only by end of this year, said sources.
Another option for India is to book Serum's second vaccine, being developed with Novovax, which may be launched before mid-2021. Serum, the world's largest vaccine maker, is expanding its manufacturing capacity at risk with an investment of Rs 2,300 crore to make over 250 crore doses of vaccines before the end of 2021.
Sources say, the move of Serum, Bharat Biotech and Pfizer India applying for emergency use authorisation (EUA) licence, soon after the Prime Minister Narendra Modi's visit to three of these manufacturers and video conference with three other companies, gains significance in this context.
The companies may be willing to go for massive expansion due to demand, but are unlikely to do so unless they are sure their vaccines have approval. Currently, the drug controller general of India (DCGI) is evaluating trial data of Serum and Bharat Biotech and have asked Pfizer India to submit more data. As and when these companies get the approval for their COVID-19 vaccines, most of them are likely to launch big expansions, which will be mostly by dedicating existing manufacturing lines and quickly setting up brownfield facilities, with liberal and speedy regulatory support. It takes 8-10 months minimum to set up a new vaccine making plant, said the sources.