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Sunday, September 27, 2020

$150-mn shot for Serum production of Covid vaccines

Production to be scaled up through $150 million in at-risk funds from the Bill and Melinda Gates Foundation

Written by Prabha Raghavan | New Delhi | Updated: September 10, 2020 3:40:11 pm
As part of this new agreement, SII will be responsible for delivering up to 100 million doses of the vaccines priced at (around Rs 225) a dose for India and low- and middle-income countries. (Getty image)

The Bill and Melinda Gates Foundation will provide $150 million of ‘at-risk’ funds to help Serum Institute of India (SII) “accelerate” the production of the Covid-19 vaccine candidates being developed by the University of Oxford-AstraZeneca and the American vaccine developer Novavax Inc.

As part of the agreement, the Pune-based Institute will supply up to 100 million doses of the vaccines to India and low- and middle-income countries through the COVAX mechanism led by Gavi, The Vaccine Alliance. India is expected to get access to 50 percent of these doses, The Indian Express has learnt.

GAVI is a public-private global health partnership committed to increasing access to immunisation, which has helped vaccinate more than 760 million children in the world’s poorest countries. The Covid-19 vaccines supplied through this mechanism are expected to be priced at $3 (Rs 225) per dose.

The collaboration will provide SII with “upfront capital” to help ramp up its manufacturing capacity in order to meet the anticipated demand for 100 million doses, the firm said.

The funding will allow the production of either or both vaccines “at scale” for distribution “as early as the first half of 2021”, once the candidates receive regulatory approvals and World Health Organisation (WHO) pre-qualification, SII said in a release.

SII has been cleared by India’s drug regulator to begin phase 2/3 trials of the Oxford-AstraZeneca candidate – branded ‘Covishield’ in India – which has successfully triggered an immune response in early trials. The Institute has also entered into a supply and licence agreement with Novavax Inc for the “development, co-formulation, filling and finishing, registration and commercialisation” of the American company’s candidate, NVX-CoV2373.

Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 57 GAVI-eligible countries. The Novavax candidate, if successful, will be available to all 92 countries supported by the COVAX Advance Market Commitment (AMC), the SII said. COVAX is a global collaboration co-led by GAVI, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO, which aims to accelerate the development and manufacture of Covid-19 vaccines, and to guarantee fair and equitable access for all countries.

“Through this association (with the Gates Foundation), we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease,” SII CEO Adar Poonawalla said.

It is unclear what price SII might set for doses of the vaccine that it supplies to India and countries outside the COVAX umbrella, as SII declined to comment on the matter.

The agreement with the Gates Foundation is separate from SII’s existing arrangement with the Swedish-British drugmaker AstraZeneca to provide a billion doses of the Oxford vaccine to low- and middle-income countries, The Indian Express has learnt.

As per that existing agreement, 50 per cent of the vaccines that SII produces will be earmarked for India, and the remaining for GAVI countries, Poonawalla earlier told The Indian Express. At that time, he had suggested that the price for the vaccine would be less than Rs 1,000.

COVAX aims to discourage bilateral agreements for Covid-19 vaccines. It aims to improve equitable access by pooling funds from donor countries to purchase vaccines mainly for lower- and middle-income countries, including GAVI nations like India.

Under the COVAX umbrella, GAVI is leading the COVAX Facility, which is expected to provide governments with the opportunity to benefit from a “large” portfolio of Covid-19 candidate vaccines developed using a range of technology platforms.

The facility is reinforced by the COVAX AMC, which is seeking at least $2 billion in seed funding, and will meet “at least part” of the cost of procurement for the vaccine doses for the 92 countries it will support.

Novavax announced its tie-up with SII in a regulatory filing with the US Securities and Exchange Commission (SEC) on Wednesday. The deal gives SII the exclusive right to supply the vaccine in India, and a non-exclusive right “during the pandemic period” to supply it to countries that are not designated “upper-middle or high-income” by the World Bank.

Earlier this year, SII was reported to have raised around $100 million to build capacity to manufacture just the Oxford candidate vaccine. Late stage trials of Covishield are expected to begin on 1,600 participants next week. This candidate is undergoing late stage human trials in countries such as Brazil, the UK, and South Africa as well.

 

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