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Home / India / Serum Institute, ICMR complete enrollment for phase-III Covid vaccine trials

Serum Institute, ICMR complete enrollment for phase-III Covid vaccine trials

Zydus Cadila set to begin phase-III trials in India after completing phase 2
Based on the phase II/III trial results, SII with the help of ICMR will pursue the early availability of this product in the country.
Based on the phase II/III trial results, SII with the help of ICMR will pursue the early availability of this product in the country.
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Our Bureau, Agencies   |   New Delhi   |   Published 12.11.20, 12:03 PM

Serum Institute of India (SII) and ICMR on Thursday announced the completion of enrolment process of 1,600 participants in the phase-III clinical trials for COVID-19 vaccine Covishield in the country.

SII and the Indian Council of Medical Research (ICMR) are collaborating on the clinical trials of the vaccine in the country.

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While ICMR has funded the clinical trial site fees, SII is taking care of other expenses for the Covishield.

Currently, SII and ICMR are conducting phase II/III clinical trial of the vaccine at 15 different centres across the country, SII said in a statement.

The entities have completed the enrolment of all 1,600 participants on October 31, it added.

"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," SII CEO Adar Poonawalla said.

The partnership further testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus, he added.

ICMR Director General Balram Bhargava said the partnership is their contribution to lending expertise and support to bolster fight against the global pandemic.

Based on the phase II/III trial results, SII with the help of ICMR will pursue the early availability of this product in the country.

SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from Drugs Controller General of India.

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

The promising results of the trials so far give confidence that Covishield could be a realistic solution to the pandemic.

ICMR and SII have further collaborated for clinical development of another COVID-19 vaccine Covovax, which has been developed by Novavax, USA, and upscaled by SII.

Zydus Cadila completes phase 2 trials

Drug firm Zydus Cadila on Thursday said it has successfully completed a phase 2 clinical trial In COVID-19 patients with its biological therapy, 'PegiHep', and it will now begin phase 3 clinical trial.

In a regulatory filing, Zydus Cadila said "it has successfully completed a phase 2 clinical trial in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHep'... Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a phase 3 clinical trial in India".

Zydus Cadila, which is a part of the Cadila Healthcare group, said Pegylated Interferon alpha 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients.

"We continue to look at possible treatment options that are safe and efficacious in the treatment and management of COVID-19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID-19," Sharvil Patel, Managing Director, Cadila Healthcare Ltd said.



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