As the world’s largest vaccine manufacturer by volume of doses produced, the Pune-based Serum Institute of India is among the keenly-watched companies in the race for a COVID-19 vaccine. It is partnering with the Oxford University-AstraZeneca vaccine project, apart from two other candidates, in initial trials. Adar Poonawalla, CEO of Serum Institute, tells Ajay Sukumaran via email that he’s expecting the Indian trials of the Oxford vaccine to be over in January 2021. Edited excerpts:
How close is Oxford-AstraZeneca to delivering its COVID-19 vaccine under an emergency licence in the UK? How soon do you hope to get efficacy and safety data from your trials in India?
The UK trials are on the verge of completion, and our Indian trials are also going smoothly. Once the regulatory bodies are confident of its safety and efficacy, we can expect the vaccine to be available from January 2021.
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What is the stockpile Serum Institute of India (SII) hopes to produce by then? Where would these be deployed initially?
We aim to initially manufacture 60-70 million doses, and to escalate manufacturing further up to 100m doses of the vaccine a month. We hope to have a stockpile of 200-300m doses by the time the trials are proven successful.
What is the vaccine efficacy you are expecting?
While we do not have the exact data since trials are going on across the world, current data shows there are no immediate concerns pertaining to this vaccine (COVISHIELD). So far, thousands of people have had it in India and abroad with no safety concerns. However, it will take two-three years to ascertain the long-term effects of the vaccine.
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Is there an estimate of the doses India would require next year? Has there been any commitment towards procurement from the government?
Keeping in mind the size of the Indian population and as per current plans to prioritise distribution among frontline workers, elderly and the young, India will need hundreds of millions of doses within the next year. We are in talks with the government to procure the vaccine.
Can you give us an idea of what the vaccine would cost?
It is too soon to talk about its price; we are talking with the government and are certain that it will be available at an affordable price for all.
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Can you tell us about the Novavax vaccine candidate which you are backing too?
We have exclusive rights for the Novavax vaccine in India and non-exclusive rights during the ‘pandemic period’ in all countries other than those designated by the World Bank as upper-middle or high-income countries. As part of our alliance with GAVI (The Vaccine Alliance) and Gates Foundation, we will be providing Novavax vaccines to 92 countries. As per our agreement, we will produce and distribute up to 2 billion doses once it has been approved by necessary authorities following its phase 2 and 3 trials.
What does 2021 look like for the SII at the moment, in terms of orders globally for your COVID-19 vaccines?
We are in the final stages of trials for COVISHIELD (the AstraZeneca-Oxford vaccine candidate) and are awaiting data on initial trials for the Novavax and Codagenix vaccine candidates. Based on the approvals from necessary authorities, we will know the status of the vaccines, following which we are expecting orders from various countries. Currently, we are working on developing an at-risk stockpile of the COVISHIELD vaccine, such that once it is proved efficacious and immunogenic, we will have available stock to initiate distribution across GAVI nations. However, we will know more following approvals and availability of the vaccine.
What has been SII’s investment into COVID-19 vaccines so far?
Currently, we have invested about $200 million for the Covid vaccine candidates in terms of optimising our production facility, technology and resources to ensure smooth production. Additionally, we have received $300m from Bill and Melinda Gates Foundation as part of our GAVI alliance.
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