Novavax, a Maryland-based biotech company that received $1.6 billion from the federal government to fund late-stage development of its experimental coronavirus vaccine, announced “positive” results in its first preliminary trial in humans Tuesday, sending its stock up 8.5% to $170.50 in after-hours trading.
Novavax enrolled 131 healthy volunteers in a Phase 1 trial and gave them either a placebo or two doses of its vaccine across two different dose levels, 5 micrograms and 25 micrograms.
Two weeks after taking a second dose, most vaccinated volunteers had high levels of neutralizing antibodies, immune-system agents that fight the virus.
The antibody concentrations were similar to those seen in serum samples from hospitalized Covid-19 patients and higher than levels seen in non-hospitalized patients.
The vaccine was “well-tolerated” and the side effects, including tenderness, headaches and fatigue were “generally mild” and not severe, Novavax said.
Novavax’s first round of testing in humans has limitations — it has not been peer-reviewed and has a small sample size — but Novavax is set to have a later-stage clinical trial with up to 30,000 subjects beginning in the fall.
Novavax has said that if its vaccine is shown to be effective, it can produce 100 million doses by the beginning of next year, or enough to give to 50 million people if administered in two doses.
Novavax has never brought a vaccine to market in its 33-year history and it uses a different formula than the other vaccines that have produced results in humans so far, according to the New York Times. Although the company has struggled financially, optimism over its coronavirus and influenza vaccine candidates has led investors to bid its stock up nearly 3,900% as of closing Tuesday.
Novavax’s coronavirus vaccine is one of 18 that have entered Phase 1 trials, the first round of testing on humans, according to the New York Times. Twelve vaccines are in Phase 2 trials and six are in Phase 3 which tests the vaccine on thousands of people. One vaccine has been approved for limited-use, the Chinese company CanSino Biologics developed a vaccine that the Chinese military approved on June 25 for a year as a “specially needed drug.”
Coronavirus Vaccine Tracker (New York Times)