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Novavax vaccine shows “markedly stronger” responses in early human trials. Eighteen months ago, a small vaccinemaker here called Novavax faced an existential threat: delisting by the NASDAQ stock index. On the heels of a second failed vaccine trial in less than 3 years, the firm’s shares had plunged to less than $1 for 30 straight days, triggering a warning by NASDAQ. Frantic to conserve cash, the company sold its two Maryland manufacturing facilities, slicing its payroll by more than 100 employees. By January, it employed only 166 people. “Good ideas. Bad management. … The company will probably die soon,” a former Novavax manager wrote on Glassdoor.com in October 2019. What a difference a year—and a pandemic—make. Today, Novavax is slated to receive up to $2 billion from the U.S. government and a nonprofit organization to develop and manufacture a coronavirus vaccine. The company’s stock closed at $80.71 per share on 30 October, it has hired more than 300 new employees, and this month it plans to launch a pivotal clinical trial of its coronavirus vaccine in the United States and Mexico. Made by moth cells harnessed to crank out the virus’ spike protein—which the pathogen uses to invade human cells—Novavax’s vaccine outshone major competitors on key measures in monkey and early human tests.
The company is one of just seven vaccinemakers to win funding so far from Operation Warp Speed, the giant multiagency U.S. government effort aiming to quickly produce at least 300 million doses of COVID-19 vaccines. But most Warp Speed–backed companies are giant pharmaceutical firms, and most have already launched late-stage clinical trials in the United States. Tiny Novavax is rushing to keep pace with its larger rivals because companies that win the first approvals from regulators will have big market advantages. Still, some observers say Novavax’s technology gives it an edge. “They are incredibly well positioned,” says Andrew Ward, a structural biologist at Scripps Research. Ward, who receives no payments from the company but owns some stock, led a team that last month published a paper in Science describing the structure of Novavax’s tailormade spike protein, the heart of its vaccine. He was impressed by its stability and conformation, as well as the vigorous antibody responses it has elicited in humans and animals. “They have the know-how,” he says. “And they obviously, as we confirmed, make a good product.” But other people are skeptical. They note that Novavax has focused on making vaccines for more than 20 years but has never brought one to market, and that its senior executives have sold tens of millions of dollars of company stock since its share price began to soar this summer. Most significantly, the company has an Achilles’ heel. Novavax must rely mostly on contract manufacturers to meet its ambitious goal for 2021: producing enough vaccine to give 1 billion people two shots each. If manufacturing problems crop up—and the company last week said manufacturing delays had slowed launch of its late stage North American trial—competing vaccines may surge ahead. “That’s concerning,” says David Maris, a veteran drug industry analyst and managing director at Phalanx Investment Partners. Where small companies such as Novavax are concerned, he adds, “people do want to believe in fairy tales.”
ON 10 JANUARY, researchers in China published the genome sequence of the virus ravaging the city of Wuhan. Three days later, Gregory Glenn, president of R&D at Novavax, asked his staff to order from a supplier the gene for the virus’ spike protein. ON 10 JANUARY, researchers in China published the genome sequence of the virus ravaging the city of Wuhan. Three days later, Gregory Glenn, president of R&D at Novavax, asked his staff to order from a supplier the gene for the virus’ spike protein. Glenn and other Novavax scientists had spent years developing “protein subunit” vaccines, so named because they employ a protein (or part of one) from the targeted virus, plus an immune-boosting compound called an adjuvant, to provoke an immune response. The company hadn’t had a commercial success—its vaccine against a serious respiratory illness failed in clinical trials. But it had produced a promising flu vaccine aimed at older adults, which was nearing the end of a pivotal trial. The company had also created protein subunit vaccines against two close cousins of the pandemic virus—the coronaviruses that cause severe acute respiratory syndrome and Middle East respiratory syndrome, using those viruses’ spike proteins. Those vaccines hadn’t made it to market, but Novavax had plenty of experience with the coronavirus family. Glenn believed it was his company’s moment...
Published in Science (Nov. 3, 2020):
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