Novax on Monday said that its COVID-19 vaccine had an overall efficacy rate of 90.4 percent in Phase III trials. The trial was conducted among 29,960 participants across 119 sites in the US and Mexico.
"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 (the COVID-19 vaccine) 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.
The protein-based vaccine saw a 93 percent efficacy against various circulating variants of concern (VoC) and variants of interest (VoI). The vaccine had an efficacy rate of 91 percent in high-risk populations. Against other variants that have not been designated as VoI or VoC, the Novavax vaccine had an astounding 100 percent efficacy. Of the 14 individuals who tested positive for COVID-19 in the vaccination group, all only showed mild symptoms, the company said.
Novavax will be applying for approval in the third quarter of the year after the completion of the final phases of process qualification and assay validation. The company is expected to take the Biologics Licence Application (BLA) after the US Food and Drug Administration announced that it would be issuing no further “emergency use authorisation” (EUA) licences. The company plans to produce 100 million doses per month by the end of the third quarter and increase it to 150 million doses per month by the end of the next quarter.
The company has also tied up with the Serum Insitute of India (SII) to manufacture its vaccine in India. The Central government expects to receive around 20 crore doses of Novavax manufactured by SII by the end of 2021.
(Edited by : Aditi Gautam)
First Published: IST