COVISHIELD finishes the enrollment of Phase III clinical trials under ICMR, SII collaboration

The Serum Institute of India (SII) with the collaboration of Indian Council of Medical Research (ICMR) have declared the completion of the total registration for the phase III clinical trials for COVISHIELD in India. As per an official release, SII and ICMR are also in a joint partnership for the clinical development of COVOVAX (Novovax) which is being developed by Novovax, USA and further upscaled by SII.

ICMR has provided the funding for the clinical trial site fees and SII has catered to the additional expenses of COVISHIELD. Currently, SII and ICMR are in the complete flow of 2/3 clinical trials to assess COVISHIELD at 15 centres in various parts of the country.

The registration of all the participants has been completed as of October 31st, 2020.

Adar Poonawalla, the CEO of Serum Institute of India, stated about the collaboration, “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.”

COVSHIELD has been produced at the SII Pune laboratory with the creation push from AstraZeneca and university of Oxford. The vaccine developed in UK is currently being assessed in large efficacy trials in the UK, Brazil, South Africa and the USA. The positive results of the trials have boosted the confidence that COVISHIELD could be an answer to the cure of the deadly virus. Moreover, COVISHIELD, turns out to be the most advanced vaccine candidate for Covid-19 so far.

From the results of the 2/3 clinical trials, SII in collaboration with ICMR will lead on the availability in India. With the stockpiling license from DCGI, SII has developed 40 million doses of the vaccine.

Dr Balram Bhargava, Directorate General, working for Indian Council of Medical Research stated, “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 leading our expertise and support to bolster our fight against the global pandemic.”

(With inputs from ANI agency)

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