By Sahil PandeyNew Delhi [India], June 14 (ANI): US Biotechnology company Novavax on Monday announced that its Covid-19 vaccine provides 100 per cent protection against moderate and severe symptoms of the disease and 90.4 per cent efficacy overall in phase 3 trials.
The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with 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. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection," said Stanley C Erck, President and Chief Executive Officer, Novavax.
"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.
According to the company's statement, it intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.
Upon regulatory approvals, Novavax remains on track to reach the 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.
The company said it was "stored and stable at 2-8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution".
Last year, Novavax, announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX-CoV2373, Novavax's COVID-19 vaccine candidate.
Novavax vaccine NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. (ANI)