Serum Institute completes phase 3 trial recruitment for Oxford-AstraZeneca Covid-19 vaccine | Health - Hindustan Times

Serum Institute completes phase 3 trial recruitment for Oxford-AstraZeneca Covid-19 vaccine

Hindustan Times, New Delhi | By
Nov 12, 2020 11:06 AM IST

At present, SII and ICMR are conducting Phase 2/3 clinical trial of Covishield at 15 different centres across the country

Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, and the Indian Council of Medical Research (ICMR), the country’s apex body for biomedical research, on Thursday announced the completion of the enrolment of participants for phase 3 clinical trials of the Oxford-AstraZeneca vaccine candidate, Covishield, in India.

Representational photo.(REUTERS)
Representational photo.(REUTERS)

SII has enrolled 1,600 healthy participants for the 3rd phase to test the efficacy of the candidate against the coronavirus disease (Covid-19). The enrollment was completed by October 31, ICMR and the company announced in a statement.

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ICMR has funded the clinical trial site fees while SII has funded other expenses for the Covishield trial.

At present, SII and ICMR are conducting Phase 2/3 clinical trial of Covishield at 15 different centres across the country.

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Covishield has been developed at the SII Pune laboratory with a master seed from Oxford University-Astra Zeneca.

The vaccine candidate made in the United Kingdom (UK) is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the USA.

“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, SII with the help of ICMR will pursue the early availability of this product for India. SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI,” said SII in the statement.

ICMR and SII have further collaborated for clinical development another vaccine candidate against Covid-19, Covovax (Novavax) developed by Novavax, USA, and upscaled by SII.

Also, US-based Novavax has initiated its late phase trials in South Africa and in the UK and will soon start the same in the US.

According to SII, it 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 ICMR and SII.

“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. The pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure. The partnership further testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus,” said Adar Poonawalla, CEO, SII.

Dr Balram Bhargava, director general, ICMR, said in a statement, “At present, India plays a prominent role in vaccine development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, SII has continually proven its research and manufacturing prowess. The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic.”

The partnership will 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, the statement further said.

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