Serum Institute readies 40m doses of Covid vaccine under ‘at risk’ manufacturing, stockpiling licence | India News

NEW DELHI: In order to ensure early availability of its Covid-19 vaccine once approved, Pune-based Serum Institute of India (SII) has already manufactured 40 million doses of the candidate developed by Oxford University and AstraZeneca, under the ‘at-risk’ manufacturing and stockpiling licence from the Indian drug regulator.
The company plans to stockpile 200-300 million doses by January and around 50% of its capacity is expected to cater to local requirements, regulatory sources said.
Serum and Indian Council of Medical Research (ICMR) on Thursday said 1,600 participants have been enrolled in the Phase 3 clinical trials for the vaccine— Covishield— in the country and, based on the Phase 2/3 trial results, SII with the help of ICMR will also pursue early availability of this product for India.

“The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic. Covishield is by far the most advanced vaccine in human testing in India,” Serum Institute said.
SII has committed supplying 200 million doses to Gavi, the Vaccine Alliance and Bill and Melinda Gates Foundation, at a maximum of $3 per dose for 2021 for low and medium income countries. It has also received around $300 million risk funding for the same. As part of the pact, SII will accelerate the manufacture and delivery of up to 100 million doses of safe and effective Covid-19 vaccines for India and low-and middle-income countries.
The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and USA.
Data from AstraZeneca’s large scale UK trials (on 30,000 volunteers) would be submitted to the Indian regulator also.
The data generated from trials in India would primarily reflect immunogenicity and safety of the vaccine candidate, whereas efficacy data would take time until a certain number of people in the placebo arm of the studies have infection.

Meanwhile, officials say India may also consider rolling reviews for the vaccine candidate which is already under accelerated scrutiny of the UK health regulator, to fast track approval of the shots in a pandemic situation. However, this can happen only if the company applies for the same.
Rolling review will enable the regulator to examine the data generated through clinical trials on a real time basis instead of waiting for the trial to be over and full data to be available for evaluation at once.
Indian authorities are betting on candidates being developed Oxford-AstraZeneca and Bharat Biotech – both of which are in advance stage of trials in India, as compared to Russia’s Sputnik-V or even the candidate developed by Pfizer. This is because both the Oxford-AstraZeneca and Bharat Biotech candidates can be stored easily, whereas the others require temperate below (—)70 degrees which can be challenging, especially in remote areas.
In another significant development, ICMR and SII have further collaborated for clinical development of Covovax, developed by Novavax, USA and upscaled by SII.

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