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Serum Institute prepares 40 million doses of Covid vaccine under “at risk” manufacturing and storage license | India News

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

“The promising trial results 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 trials in India, ”said Serum Institute.
SII has committed to providing 200 million doses to Gavi, the Vaccine Alliance, and the Bill and Melinda Gates Foundation, at a maximum of $ 3 per dose by 2021 for low- and middle-income countries. He has also received hedge funds of around $ 300 million for the same. As part of the pact, the 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 UK-made vaccine is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the US.
Data from AstraZeneca’s large-scale trials in the UK (on 30,000 volunteers) would also be sent to the Indian regulator.
The data generated from the trials in India would primarily reflect the immunogenicity and safety of the candidate vaccine, while the efficacy data would take time until a certain number of people in the placebo arm of the studies have the infection.

Meanwhile, officials say India may also consider continued reviews for the candidate vaccine, which is already under accelerated scrutiny from the UK health regulator, to speed up approval of vaccines in a pandemic situation. However, this can only happen if the company requests the same.
Ongoing review will allow the regulator to examine data generated through clinical trials in real time rather than waiting for the trial to end and the full data to be immediately available for evaluation.
Indian authorities are betting on Oxford-AstraZeneca and Bharat Biotech candidates being developed, which are in an advanced stage of testing in India, compared to Russia’s Sputnik-V or even the candidate developed by Pfizer. This is because the Oxford-AstraZeneca and Bharat Biotech candidates can be easily stored, while the others require temperatures below (-) 70 degrees, which can be challenging, especially in remote areas.
In another significant development, ICMR and IBS have further collaborated for the clinical development of Covovax, developed by Novavax, USA and enhanced by IBS.

Times of India

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