New Delhi: Novavax Inc, which has a vaccine manufacturing agreement with Serum Institute of India, said its COVID-19 vaccine candidate was highly effective with 90.4 per cent efficacy overall and also showed high efficacy against predominantly circulating variants.
The vaccine candidate ‘NVX-CoV2373’ demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial, Novavax said in a statement, according to news agency PTI.
The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine, it added.
The vaccine demonstrated 93 per cent efficacy against predominantly circulating variants of concern and variants of interest, Novavax said.
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Novavax President and Chief Executive Officer Stanley C Erck said.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines,” he added.
The company intends to file for regulatory authorisations in the third quarter.
Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021, it added.
As per reports, the Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
The vaccine was effective against several variants, including the one first detected in the UK that’s dominant in the US, and in high-risk populations including the elderly and people with other health problems.
The company has committed to supplying 110 million doses to the US over the next year and a total of 1.1 billion doses to developing countries.
Earlier in March, Serum Institute of India (SII) CEO Adar Poonawalla had said that clinical trials of the vaccine ‘Covovax’ have begun in India and the company hopes to launch it by September this year.
In September 2020, Novavax had announced COVID-19 vaccine manufacturing agreement with SII, increasing Novavax’s global production capacity of NVX-CoV2373 to over 2 billion doses annually.