REUTERS/Dado Ruvic
On Monday, the US-based Novavax said that its nano-particle protein-based Covid-19 vaccine candidate had demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials.
The company said that the jab demonstrated 100% protection against moderate and severe disease with an overall 90.4% efficacy.
In India, its partner Serum Institute of India (SII), has started manufacturing the vaccine, which has been named Covovax already.
The company had enrolled 29,960 participants across 119 sites in the U.S. and Mexico in the study to evaluate the efficacy, safety and immunogenicity of the vaccine.
According to the company, the researchers observed a total of 77 cases of COVID-19 in the randomized, placebo-controlled, observer-blinded study. Among these, there were 63 cases in the placebo group and 14 in the vaccine group. Ten were moderate, and four were severe, all in the placebo group. All cases in the vaccine group were mild.
The Maryland-headquartered company added that it intends to apply for regulatory approval by the third quarter of 2021, as per AFP's report.
The vaccine, which can be stored at refrigerator temperatures, also demonstrated 91% efficacy among high-risk populations, including people over the age of 65 and those under 65 with certain comorbidities or who have frequent exposure to COVID-19.
Novavax, named Covavax in India, is 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 has also indicated an interest in conducting trials in children, official sources said.
As per the new vaccine approval regulations, SII will launch the vaccine in India if Novavax gets Emergency Use Authorisation in the US. It may well be possible that India becomes the first country for the launch of the vaccine.
This vaccine was scheduled for a September 2021 launch in India. The Indian government expects to get 20 crore doses of this vaccine from SII.