The randomized, placebo-controlled trial began enrolling adult volunteers, approximately 30,000 people, at 115 sites in both countries. Two-thirds of those or 20,000 people will receive the vaccine, with the remaining taking a placebo.
The plan is to recruit people particularly vulnerable to the virus for the study, including ensuring a quarter of participants are over 65 and at least 15 percent are black.
With this, Novavax becomes the fifth Covid-19 vaccine candidate to enter late-stage trials in the West before the end of the calendar year. The U.S. Food and Drug Administration has already granted two candidates – from BioNTech-Pfizer and Moderna – emergency use authorization.
“With the Covid-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” Novavax chief executive Stanley Erck said.
The company is already holding phase-3 trials in the United Kingdom, with support from Britain’s task force for vaccines.
Results are expected in the first quarter of next year and will be used to apply for regulatory approval in the UK and Europe. Early-stage studies are also ongoing in South Africa as well as in Australia.
Like most of the Covid-19 vaccine candidates, the Novavax jab requires two shots spaced three weeks apart.
But the vaccine, stable at between 2 and 8C, does not require very cold temperatures for storage, transportation, and distribution unlike the shots by BioNTech-Pfizer and Moderna. They only need to be refrigerated, not deep-frozen, and thus can be manufactured using existing equipment.
Significant advancements in its development of a vaccine against the novel coronavirus have sent Novavax stock up this year, with its share price rising 2,781 percent since the start of 2020 according to the Financial Times.
The speed at which Novavax candidate made it to late-stage clinical trials signifies a notable achievement for the 20-year-old company, which has never produced a vaccine that’s reached the public before. In 2016, the stock suffered a huge drop after the company’s vaccine for a respiratory virus failed in a clinical trial.
Novavax Covid-19 vaccine development has been mainly funded by a $1.6 billion award from the government’s Operation Warp Speed, in what is one of the programme’s largest grants to vaccine makers.