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Vaccine maker Serum Institute of India (SII) announced on Thursday the completion of enrolment of Phase III clinical trials for Covishield vaccine.
Serum Institute and the Indian Council of Medical Research (ICMR) enrolled 1,600 volunteers to administer the Oxford University- AstraZeneca vaccine. The vaccine maker has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from the Drug Controller General of India.
The Covishield vaccine comprises two doses. Around 1,000 volunteers have already received the first shot of the Covid-19 vaccine and the second booster dose has to be administered 29 days after the first shot for ensuring full protection. This process of administering vaccine to volunteers is expected to be completed over the next two to three weeks, the company said.
ICMR has funded the clinical trial site fees, while SII has funded other expenses for Covishield. They are conducting the ongoing clinical trials across 15 centres in India. There have been no adverse reports so far in the country.
The promising result of the trials so far gives confidence that the Covishield could be a solution to the pandemic. SII has developed the Covidshield vaccine at SII Pune laboratory with a master seed from Oxford University-Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and USA.
ICMR and SII have also collaborated for clinical development of the Covovax vaccine, developed by Novavax, USA and upscaled by SII. This vaccine formulated at SII will be tested in a Phase III trial in India. SII and ICMR will be soon seeking regulatory approval for starting these trials in India. Novavax has already initiated its late phase trials in South Africa and the UK and will soon commence the same in the USA. SII has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials.
Adar Poonawalla, CEO of SII, said, the ICMR-SII collaboration would put India at the forefront of developing an immunogenic and efficacious vaccine. This partnership testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus, Poonawalla said.
Dr Balram Bhargava, DG, ICMR, said the partnership will see 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.