Serum Institute of India resumes vaccine exports under COVAX facility

Exports resume after eight-month hiatus, over 1.25 billion doses produced against year-end target of 1 billion

Serum Institute of India, the world's largest vaccine maker, on Friday said it has resumed exports of Covishield vaccine to low- and middle-income countries with the first batch of consignment leaving its Pune facility.

An unnumbered amount of doses of the AstraZeneca shot were shipped for export under the Covax initiative, with Serum hoping to increase doses "substantially" into the first quarter of next year and to include Novavax Inc's inoculation at an unspecified time.

Serum Institute of India (SII) has cumulatively produced 1.25 billion doses so far, a company statement said.

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India had halted Covid vaccine exports in April to cater to domestic demand as infections shot up. It decided to resume exports after the domestic inoculation drive gained momentum and enough doses were available to meet future needs.

"The first batches of its Covishield Covid-19 vaccine left the SII manufacturing facility in Pune earlier today, for distribution to low- and middle-income countries via the COVAX mechanism," it said. "SII's supply of doses via COVAX is expected to increase substantially into Quarter 1 2022."

The resumption of exports, it said, is linked to the company surpassing its original target to produce 1 billion (100 crore) doses of Covishield by the end of this year.

"SII has reached this milestone ahead of time via rapid expansion of production capacity at its site in Pune," it said.

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Doses to Covax from SII are dedicated to supplying 92 lower-income countries.

Covax is a multilateral initiative that aims to provide access to Covid vaccines to all countries, led by the Global Vaccine Alliance (Gavi), the World Health Organisation (WHO) and Coalition for Epidemic Preparedness Innovations (CEPI).

"It's a huge moment to begin exports again," SII Chief Executive Officer Adar Poonawalla said in the statement. "The world has largely depended on the low-cost, high-quality pharmaceuticals and vaccines that India has traditionally exported."

To bolster its Covid-19 vaccine output even further, SII will bring into production other vaccines under licence. These include Covovax, from US-based company Novavax, which received its first Emergency Use Authorisations (EUAs) from regulators in Indonesia and the Philippines this month.

Further regulatory reviews are pending for Covovax in India and with the WHO. Novavax has also submitted several additional regulatory filings for its vaccine around the world.

While India resumed a small number of bilateral vaccine exports to neighbouring countries last month, dispatches to Covax were not restarted until after the WHO granted emergency authorisation to the domestically developed Covid shot, Covaxin.

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"We started to invest at-risk in Covid-19 vaccine production back in March 2020," Poonawalla said.

With collaborations with global partners including AstraZeneca, the Bill & Melinda Gates Foundation, Gavi, UNICEF and the WHO and new Covid-19 vaccines such as Covovax entering SII production lines, "we can be more hopeful that WHO's target to vaccinate 70 per cent of the world's population by the middle of next year can be met," he said.

Beyond this, SII will continue to work with its global partners on promising programmes in HPV and malaria and will continue to fight health inequality globally by making vaccines more accessible and affordable, he added.

Seth Berkley, CEO of Gavi, the vaccine alliance which leads the Covax facility, said: "The resumption of supplies from Serum Institute of India is an important development for COVAX as it enters its busiest period yet for shipping vaccines to participating economies."

"While COVAX’s portfolio is now much more diversified than it was earlier this year when we received our first SII deliveries, Covishield remains an important product that has the potential to help us protect hundreds of millions of people in the months ahead," he added.

Throughout the pandemic, SII has also been able to maintain its supply of non-Covid-19 vaccines to low- and middle-income countries, including vaccines for polio, measles and pneumococcal disease, the statement said.

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