By Nikhila Natarajan

New York, Aug 28 (IANS): India is on course to have an "approved" vaccine within the first quarter of the calendar year 2021 and Pune based Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, is well placed to deliver the first vaccine, according to a report out Thursday from Bernstein Research, a top Wall Street research and brokerage firm.

"Globally, there are four candidates that are close to approval by the end of the CY2020 or early 2021. Through partnerships India has access to two of those - AZ/Oxford's viral vector vaccine and Novavax's protein subunit vaccine with AZ/Oxford's vaccine ahead by a quarter," says the Bernstein report, which IANS has reviewed.

"With their existing capabilities and capacities, SII is best positioned to commercialize one or both of the partnered vaccine candidates depending on approval timing, capacities and pricing."

Data from Phase 1 and Phase trials look promising for both these candidates "in terms of safety and the vaccines' ability to elicit an immune response". The way things look now, the report indicates that both vaccine candidates "will require two doses to be administered 21/28 days apart".

The report strikes an upbeat tone on India's "global capacity equation" and does not foresee "manufacturing scale-up challenges".

Serum Institute of India, the report says, could supply 600 million doses in 2021 and 1 billion doses in 2022, out of which 400 to 500 million "should be available in India in 2021" in the context of the company's commitments to Gavi The Vaccine Alliance and lower and middle-income markets.

The report estimates that vaccine volumes will be split 55:45 between the government and the private market.

"We believe the government channel will have first access to the capacities but also believe there will be a sizable private market. In terms of funding, manpower and delivery infrastructure the Government will struggle to shoulder the burden on its own and we expect the private market to step in and supplement."

SII has announced that Gavi will procure vaccines at $3 per dose. The Bernstein report uses that as a benchmark to estimate procurement price to be around $3 a dose for the government and end consumer price of about $6 per dose.

Apart from SII, the report lists at least three other Indian pharma companies - Zydus, Bharat Biotech and Biological E - which are working on their own vaccine candidates and are currently in Phase 1 and 2.

Between SII, Bharat Biotech, Biological E, and some smaller players, India produces around 2.3 billion doses of various vaccines every year.

SII alone is the globally largest manufacturer of vaccines with 1.5 billion doses capacity. Every two out of three children globally get a shot manufactured by SII.

In early August, SII entered into a partnership with Gavi, The Vaccine Alliance and the Bill and Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs).

The collaboration pumps upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and lower and middle-income nations as quickly as the first half of 2021.

The overall vaccine market in India is estimated at "$6 billion spread over FY 21-22", according to Bernstein.