India could have access to at least 40 million doses of the Oxford-AstraZeneca vaccine ready to ship from Serum Institute of India (SII) facilities in Pune, potentially helping the country catch up with other nations that have begun vaccinating their citizens.
The vaccine, which was recommended for emergency use in India on Friday, is at present the only candidate that will be readily available in mass volumes for the country, but its stockpiles may be among the largest, SII executives have said in recent days. This, coupled with the vaccine’s compatibility with the Indian cold chain network are factors that could help a quick roll-out.
With the manufacturing and stockpiling license, the Serum Institute of India has already been able to stockpile 75 million doses of the Oxford/AstraZeneca vaccine and by the first week of January, we will have 100 million doses. Nobody across the world has so much stock and we can start supplying as soon as we get the approval,” said Umesh Shaligram, director of Research and Development at SII, at a webinar on Thursday.
Earlier in the week, SII chief executive Adar Poonawalla told reporters that 50% of doses produced will be split between India and Covax Facility, a WHO-led pool to distribute vaccines to low and middle-income countries (LMIC).
“…We have always said that we will keep giving 50% of everything we make to India and to Covax at the same time. So, if we are producing 60-70 million doses every month, there will be plenty of vaccines to go around both to India and to Covax countries, including some of our neighbours like Bangladesh etc. because everybody wants the vaccine, and we are trying to give as much as we can and equitably to nations including India,” he said.
Initially, the company may give most of its production to India because to export to these countries, it would need WHO’s pre-qualification, Poonawalla said on Monday.
“… that may take another month or so after it is licensed in India. That way India will have priority, and because India is such a large country that we may end up giving a majority of those 50 million doses to India first. Every month we are churning out 40-50 million doses which will go up to about 100 million doses every month by March as by then we are going to commission a third facility that is getting ready. Eventually everyone is going to get it; of course some countries will have to wait a little longer,” he said.
According to Our World in Data, close to 10 million vaccinations have already taken place across the world, with China, the US, the UK and Israel having administered the most doses. Among these, Israel has the highest proportion of its population that has received the vaccine at 11%.
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In terms of volume, China has administered the highest numbers at 4.5 million, but none of its domestically made vaccines have yet been cleared following adequate safety and efficacy trials.
Globally, the Oxford-AstraZeneca vaccine ticks two crucial boxes – it has received approvals after due scientific process and has secured the most deals for production as well as distribution. According to science analytics company Airfinity, 2.6 billion doses of the vaccine are expected to be produced in 2021. In terms of committed supplies, Oxford and AstraZeneca have been given orders for 3.7 billion doses.
In terms of supply volumes, the next largest volumes have been projected for the candidate by Novavax, which too is being manufactured by SII. Novavax is making a vaccine using a tried-and-tested recombinant protein platform and has shown encouraging results, it is likely to take a few more months before late stage trials show efficacy results – the key marker for an inoculation to be assessed.
Novavax’s deal with SII could assure India of more supply advantage later this year, since Poonawalla has previously indicated that 50% of all production by the company will be set aside for domestic supplies.
India’s other large supplies could come from Hyderabad-based Bharat Biotech, which began its Phase 3 trials in mid-November, and is stated to have an annual production capacity of 300 million doses. A second India-made vaccine is by Gujarat-based Zydus Cadila, which is yet to proceed to Phase 3 III trials.
The third highest projected global production for 2021 is for Pfizer-BioNTech at 1.3 billion, according to Airfinity’s assessments, but the dose is considered unfeasible for poorer countries because of its high price and its ultra-cold storage requirements that will need special networks to be erected. The vaccine is expected to cost $20 a dose.
This has made the Oxford-AstraZeneca – which will cost $3-4 per dose — earn the “vaccine for the world” label by several experts. The companies committed to equitable distribution when in June it reached a $750m agreement with Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, vaccine alliance to support the manufacturing, procurement and distribution of 300 million doses.
Shortly after, it struck a licensing agreement with SII to supply one billion doses for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020.
The efficacy numbers reported from the Oxford-AstraZeneca trial fall below those reported for the mRNA vaccines made by Pfizer-BioNTech and Moderna, but it is still well above the 50% threshold identified by regulators around the world as the bar for a vaccine to be considered effective.
Dr Shahid Jameel, director of Trivedi School of Biosciences at Ashoka University and former CEO of Wellcome Trust/DBT India Alliance said the SEC’s recommendations are “probably the best news in a while”. “The good thing is that we are manufacturing it and we do not need to go begging for the doses. However, people will still have to take precautions because the vaccines have shown to protect from the disease and not infection. What this means is a vaccinated person can continue transmitting the infection to a susceptible population,” he said.