ICMR, SII complete enrollment of phase 3 clinical trials for Covishield vaccine

The Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) announced the completion of enrollment of phase 3 clinical trials for Covishield in India.

ICMR and SII have further collaborated for clinical development Covovax (Novavax) developed by Novavax, USA and upscaled by SII.

“The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak,” SII said in a statement on Wednesday (November 11).

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

At present, SII and ICMR are conducting Phase 2/3 clinical trial of Covishield at 15 different centres, across the country. It has completed the enrollment of all 1,600 participants on October 31.

Covishield has been developed at the 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.

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“The promising result of the trials so far gives 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,” SII said.

Commenting on the association, Adar Poonawalla, CEO of SII, 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.”

Dr. Balram Bhargava, Director General of ICMR, said, “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 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.

18 pharma companies unite

Meanwhile, a united group of 18 pharma companies including India’s Sun Pharma, Lupin, Aurobindo, Zydus Cadila, Hetero, Natco and Strides Shasun, representing a large portion of the world’s generic pharmaceutical manufacturers pledged to work together to accelerate access to hundreds of millions of doses of new interventions for low and middle-income countries (LMICs) via the non-profit Medicines Patent Pool (MPP).

“This unprecedented cooperation from companies that are typically competitors represents a breakthrough in our efforts to level the playing field for access to drugs that will be crucial to controlling and defeating this pandemic,” said Charles Gore, Executive Director of MPP.

“These are companies with an excellent track record of working with originators to ensure generic versions of their innovations meet high standards for quality – while answering the need for more affordable, accessible therapies,” Gore added.

Gore said he hopes the pledge by such a respected group of generic industry players to produce large volumes of high-quality COVID-19 treatments will encourage firms now developing either new or re-purposed therapies to negotiate agreements allowing rapid access to those in need.