Pune-based Serum Institute of India, which is world's largest vaccine manufacturer by volume, is likely to start the clinical trials of US biotech firm Novavax's Covid-19 vaccine candidate in India from next month, reports Economic Times.
For the human clinical trials of the Novavax's vaccine, the Serum Institute will reportedly partner with the Indian Council of Medical Research (ICMR).
According to the report, the trials of the glycoprotein subunit nanoparticle adjuvanted vaccine, NVX‑CoV2373, developed by Novavax will be led by 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,” one person aware of the matter was quoted by ET as saying.
Earlier in August, Novavax had entered into a supply and licence agreement with Serum Institute for the development and commercialisation of its Covid-19 vaccine candidate.
Novavax on Tuesday (15 September) said that its experimental Covid-19 vaccine produced high levels of antibodies against the novel coronavirus in a small, early-stage clinical trial, and that it could start phase 3 trials as soon as late September.
The US biotech firm has also revised its deal with Serum Institute in order to produce 2 billion doses of Covid-19 vaccines.
As a part of the expanded agreement, Serum Institute will manufacture the antigen component of Novavax’s Covid-19 vaccine candidate, NVX CoV2373.
“Today’s agreement with Serum Institute enhances Novavax’ 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 and Chief Executive Officer of Novavax, in a statement on Tuesday.
“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," Erck added.
It should be noted that Serum is also conducting the clinical trial of the Oxford-AstraZeneca Covid-19 vaccine candidate in India. The trial was put on hold after an adverse event was reported in an overseas participant. However, the Drug Controller General of India (DCGI) allowed Serum Institute to resume the trial after AstraZeneca resumed its trials following a review of the incident.
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