Named as Covavax in India, the Serum Institute of India (SII) will be the manufacturing partner in the country with around 20 crore shots’ delivery that is likely to happen between September and December 2021.
US biotechnology firm Novavax announced on Monday that its jab is more than 90 percent effective, including against coronavirus variants.
According to Novavax, the jab “demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall,” the company said in a statement, adding “the study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity.”
NEW DATA RELEASE: Novavax #COVID19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial https://t.co/lIOiQXxDtD pic.twitter.com/4ePHxDpziZ
— Novavax (@Novavax) June 14, 2021
The Maryland-headquartered company said it intended to apply for regulatory approval by the third quarter of 2021 and will be the fourth vaccine if allowed, in the US.
Unlike some rival jabs, Novavax’s vaccine — formally known as NVX-CoV2373 — does not have to be stored at ultra-low temperatures.
The company said it was “stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution.”
The Novavax study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, safety, and immunogenicity. It laid an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines,” said Novavax President Stanley C. Erck. The company intends to file for regulatory authorizations in the third quarter of 2021.
Also Read: India Records 60,471 New Covid-19 Cases, Lowest Since March 31
Named as Covavax in India, the Serum Institute of India (SII) will be the manufacturing partner in the country with around 20 crore shots’ delivery that is likely to happen between September and December 2021.
The vaccine is currently in advanced stages of Phase 2/3 “observer-blinded, randomised active-controlled” bridging trials with SII enrolling 1,600 participants over 18 years across 15 centres.
SII is also keen on conducting trials in children, official sources told TOI.
“The results are very encouraging and we are looking forward to the vaccine. We are already engaged with SII for supplies and the company is doing trials with ICMR. It is a very promising vaccine candidate and we are hopeful that they will be able to submit data in India for regulatory approvals” an official said.
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