Coronavirus | COVISHIELD completes enrolment of Phase-3 clinical trials under partnership of ICMR and Serum Institute of India

The ICMR funded the clinical trial site fees while the SII provided the other expenses for the vaccine, said a release.

Updated - November 12, 2020 11:19 pm IST

Published - November 12, 2020 10:35 am IST - NEW DELHI:

A volunteer receives a COVISHIELD vaccine shot in Visakhapatnam. File

A volunteer receives a COVISHIELD vaccine shot in Visakhapatnam. File

The Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) on Thursday announced the completion of enrolment of Phase-3 clinical trials for COVISHIELD in India .

“The ICMR and the SII have further collaborated for clinical development of COVOVAX (Novavax) developed by Novavax, USA, and upscaled by the SII,” noted a release issued by the ICMR.

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It added that the ICMR had funded the clinical trial site fees while SII had funded other expenses for COVISHIELD.

At present, the SII and the ICMR are conducting Phase-2 and 3 clinical trials of COVISHIELD at 15 different centres, across the country.

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It has completed the enrolment of all 1,600 participants on October 31, 2020.

COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in U.K. is currently being tested in large efficacy trials in U.K., Brazil, South Africa and the U.S.

‘Realistic solution’

“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. Based on the Phase 2/3 trial results, the SII with the help of the ICMR will pursue the early availability of this product for India. The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from the DCGI,” said the release.

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The ICMR added that the U.S.-based Novavax has initiated its late phase trials in South Africa and U.K. and will soon commence the same in the U.S. “The SII has received the bulk vaccine and Matrix-M 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 the ICMR and the SII,” noted the release.

Commenting on the association, Adar Poonawalla, CEO of Serum Institute of India, said, “ICMR has played a huge role in coming forward and strengthening India’s fight against COVID-19. The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine.”

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Balram Bhargava, Director General of the ICMR, said, “At present, India plays a prominent role in vaccine development and manufacturing globally.”

He added that the partnership would see the scientists of both the entities facilitate the advancement of regulatory approvals for COVISHIELD and COVOVAX while ensuring strict adherence to all the requisite scientific, ethical and regulatory standards.

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