Separately, India’s drug regulator allowed SII on Tuesday to resume clinical trials of the University of Oxford-developed Covid-19 vaccine candidate. The trial was put on hold after an adverse event was reported in an overseas participant.
The trials of the glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax will be led by Indian Council of Medical Research (ICMR) -National AIDS Research Institute, Pune.
“The trials for the vaccine developed by Novavax will start next in October. It will be initiated after the vaccine is manufactured by SII,” said one person aware of the matter.
Novavax had entered into a supply and licence agreement with SII in August for the development and commercialisation of its Covid-19 vaccine candidate.
Novavax said on Tuesday that its experimental Covid-19 vaccine produced high levels of antibodies against COVID-19 in a small, early-stage clinical trial, and that it could start phase 3 trials as soon as late September.
Novavax has also revised its deal with SII in order to produce 2 billion doses of Covid-19 vaccines. As a part of the expanded agreement, SII will manufacture the antigen component of NVX CoV2373, Novavax’s Covid-19 vaccine candidate.
“Today’s agreement with Serum Institute enhances Novavax’s commitment to equitable global delivery of our Covid-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents,” said Stanley C Erck, president of Novavax.
“We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks,” the company said in a statement.
According to the Department of Biotechnology, more than 30 vaccine candidates are in various stages of development.
Cadila and Bharat Biotech have completed phase-I trials.
“Phase I trials along with parallel studies in large animals have been completed. The trial has revealed excellent safety of the candidate vaccine,” the official added.
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2 Comments on this Story
Abhijit Mukherjee39 days ago
Everything is left for the future, people are losing interest. Many will show little interest in vaccine if they grow in confidence that they will survive, vaccine or no vaccine.
Yash Pal39 days ago
All very goo but what is in it for ordinary Indian? The vaccine has to be made available by Jan 21 at the latest to stop the unhindered march of this virus.