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Friday, December 04, 2020

SII: 40 million doses of Covishield in stock, to ensure early availability

As on Thursday, SII had managed to enroll the 1,600 participants it was targeting for mid- to late-stage trials (phase 2/3) trials of Covishield.

By: ENS Economic Bureau | New Delhi | Updated: November 13, 2020 12:32:45 am
New phase 2 trial results of Oxford vaccine show success in older peopleThe man, it alleged, suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.

In an effort to ensure sufficient supply and “early availability” of its Covid-19 vaccine, Covishield, in India, Serum Institute of India (SII) has already made and stockpiled 40 million doses of the candidate ‘at-risk’, the company said Thursday. The Pune-headquartered firm, which has also tied up with American vaccine firm Novavax for a separate Covid-19 vaccine, plans to apply to regulatory authorities in India “soon” to conduct late-stage human trials.

As on Thursday, SII had managed to enroll the 1,600 participants it was targeting for mid- to late-stage trials (phase 2/3) trials of Covishield, the vaccine candidate developed using a “master seed” from the vaccine candidate developed by The University of Oxford in collaboration with Swedish-British drug giant AstraZeneca.

The trials in India are currently in the third phase and SII has partnered with the Indian Council of Medical Research to conduct these trials here.

The Oxford University-AstraZeneca candidate is currently being tested in efficacy trials in the UK, Brazil, South Africa and the US. In late October, the vaccine was shown to prompt an immune response not only in younger age groups, but also the elderly population known to be among the most vulnerable demographic during the ongoing pandemic.

“The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic,” said SII in a statement. Based on the phase 2/3 trial results in India, the Pune firm and ICMR will pursue the “early availability” of this product here.

“SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI (Drug Controller General of India—the country’s top drug regulator),” stated the firm.

ICMR and SII have further collaborated for clinical development of ‘Covovax’, the candidate developed by Novavax that will be upscaled by SII.

Novavax has initiated late phase trials of the candidate in South Africa and the UK and plans to start similar trials in the US. SII has received the bulk vaccine and adjuvant from Novavax and will soon fill and finish them in vials.

“This vaccine formulated at SII (Covovax) will be tested in a phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII,” stated SII.

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