New Delhi: Covaxin, the Covid-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has received approval for conducting final phase trials. Also Read - Serum Institute, Bharat Biotech to Begin Late-Stage Trial of Intranasal Covid-19 Vaccine Soon
The Drugs Controller General of India (DCGI)’s expert committee met on Tuesday and permitted the Hyderabad-based firm to initiate Phase 3 trials. Also Read - India Corona Vaccine Latest News: Bharat Biotech's 'Covaxin' to be Tested For Phase-3 Trials in Uttar Pradesh | Read Here
The expert panel’s approval came after assessing data from Phases 1 and 2 along with animal trials. However, the committee suggested “minor amendments” in the protocol. Also Read - COVID-19 Vaccine Update: Animal Trials of Covaxin Successful, Announces Bharat Biotech; Says Results Demonstrate Protective Efficacy
The Phase 3 trials for Covaxin are likely to start next month. Applying for the approval on October 2, Bharat Biotech told DCGI that the study will involve 28,500 volunteers from ten states. The subjects will be given two doses of the experimental vaccine within a gap of 28 days.
Meanwhile, IAVI, a non-profit scientific research organisation and Serum Institute of India announced an agreement with Merck to develop SARS-CoV-2 neutralising monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the Covid-19 pandemic.
The agreement builds on the advanced antibody discovery and optimization expertise of IAVI and Scripps Research, gained from years of experience in HIV broadly neutralising antibody research and development, and on Merck’s and Serum Institute’s significant capabilities in design and scale up of accelerated manufacturing processes for mAb production. The global development plan is being led by the three organisations in partnership.
The two companies have broad networks across complementary geographic areas that will be crucial to reach given the worldwide spread of Covid-19.
If the highly potent and broadly cross-reactive SARS-CoV-2 neutralising antibody candidates being advanced through this partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck will lead commercialisation in developed countries.
Serum Institute has a proven track record of more than 50 years in developing affordable medicines and is the world’s largest producer of vaccines. Serum Institute will lead global manufacturing as well as commercialisation in low- and middle-low-income countries, including India.
“We’re acutely aware of the tremendous potential for monoclonal antibodies to be used in Covid-19 response. By combining the scientific achievements of IAVI and Scripps Research with our partners’ development, manufacturing, and distribution expertise, we are hopeful that this partnership will result in globally accessible antibodies that are available to all who can benefit from them,” said Mark Feinberg, President and CEO of IAVI.
(With inputs from IANS)