Serum Institute, Bharat Biotech gear up to export Covid-19 vaccine shots

Serum, Bharat Biotech in talks with countries, agencies to supply vaccines

Indian vaccine makers are gearing up for exporting the Covid-19 vaccine overseas as they start manufacturing the doses at risk at their plants. 

It would be critical to recover the costs these firms have incurred to develop the vaccine candidates, which are now in the final stages of trials. 

Sample this: The world’s largest vaccine maker, Serum Institute of India (SII), already has a 3.2 billion doses supply commitments in its kitty over the next two years. Some of this would be for India. According to sources close to the development, the firm is in talks with Bangladesh and some other Asian countries for supplying the vaccine. 

SII typically exports more than 60 per cent of its vaccine production every year and has arrangements with the World Health Organization (WHO), Gavi, Cepi, UNICEF, and other global procurement agencies. It had made 1.5 billion doses of vaccines at its Pune plants last financial year. 

SII is currently busy making the Covid-19 vaccine for which it has tied up with AstraZeneca. It will be supplying 1 billion doses to AstraZeneca, of which around 50 per cent would be for India. It would also supply 2 billion doses to Novavax for its vaccine candidate. The phase 3 trials for Novavax have not yet started in India. This apart, SII would supply 200 mn doses to Gavi of both the Novavax and AstraZeneca vaccine at $3 per dose. 

All put together, SII already has commitments 3.2 billion doses. Of this, 500 mn doses of the AstraZeneca vaccine are likely to be for India. As such Gavi would be supplying the vaccines procured from SII to low and medium income countries. 

Sources said, “SII will have a capacity to make around 2 billion doses of the Covid-19 vaccine next year by June or so. This can be ramped up to 2.3 billion doses maximum by the end of 2021. SII also has to supply the other routine vaccines for the universal immunisation programme and it is making and stockpiling those vaccines now.” The person said the supply commitments of 3.2 bn doses will therefore be met over 2021 and 2022.  Indian government procures 300 million doses of various vaccines to vaccinate around 24 million children every year. SII supplies a bulk of it. 

Another leading vaccine player in the race, Bharat Biotech, which is now conducting phase 3 trials for its vaccine candidate Covaxin, expects to have partnerships in place by next month. 

Sai Prasad, executive director of Bharat Biotech International, told Business Standard they were expecting to forge global partnerships with international agencies like Gavi and also some countries by December.  “Our first priority will be to supply to our own country. We are also in talks with several nations and international agencies like Gavi who are interested in our vaccine,” Prasad said. He explained that these partnerships could be of three types: Some countries want to do their own clinical trials, others want to buy the vaccine, and some want BBIL to do a tech-transfer so that a local company can make the vaccine. 

Meanwhile, the Hyderabad-based firm is setting up a second plant at its Genome Valley facility in the city to make Covaxin. It is actively looking for another site in India where it can make the vaccine. Together the two plants in Hyderabad’s Genome Valley can make up to 150 million doses for India, and with a third site, the firm expects to take the capacity up to 500 million doses per year. BBIL is spending around Rs 100-150 crore to set up the new manufacturing plant. It has already started at-risk manufacturing of the vaccine and has some doses ready. Ahmedabad-based Zydus Cadila, too, is open to global partnerships for its DNA plasmid vaccine candidate ZyCoV-D, which is entering phase 3. It has not yet announced any global partnership. 

A senior official at an Indian vaccine maker pointed out that these global supply arrangements would be critical to recover costs. “The cost of conducting large-scale phase 3 clinical trials over say 30,000 people is around Rs 150 crore. Add to this the cost of developing the vaccine and the phase 1 and 2 trials apart from the animal trials,” he said.

The government has announced a Rs 900-crore stimulus for Covid-19 vaccine research. While it would cover part of the costs, firms feel that global deals would be critical to recover costs. In India, they are likely to supply at lower costs to the government. 

SII is likely to supply Covishield to Indian government at Rs 250 per dose while it would sell it in the private market for Rs 500-600 per dose.