Gaithersburg-based Novavax, a life sciences company that develops vaccines for infectious diseases, could begin testing a vaccine to stem the spread of Ebola in humans as soon as December, the company’s chief executive said.
Should the vaccine prove to be safe and effective, there still would be more work to do. Executives said it remains unclear how quickly the medicine would be available for health workers and military personnel working in areas stricken with Ebola.
Chief executive Stanley C. Erck said the company would expect to have results from its initial trial in humans during the first three months of 2015 and, based on those results, could plot a path toward selling the vaccine later that year.
To get to that stage, Novavax would require both positive test results and an agreement with the Food and Drug Administration to expedite the approval process.
Novavax has developed technology that uses the genetic code of particular strain of virus to generate a vaccine. It has allowed the company to respond quickly to recent outbreaks of influenza and the Middle East Respiratory Syndrome, known as MERS.
“What our technology allows us to do is quickly make a vaccine that is both safe and stimulates antibody responses to emerging diseases,” Erck said. “Ebola comes up and that is a virus that is a perfect fit for our platform.”
The company began work on an Ebola vaccine as soon as scientists had mapped the genetic sequence of the strain responsible for the ongoing outbreak in West Africa. Novavax has already tested the vaccine in rodents and rabbits, and plans are underway for a trial in baboons.
“Safety in vaccines is really important because when you develop cancer drugs or drugs for severe diseases, you can afford to have drugs that work but have some side effects,” Erck said. “But with vaccines, you’re working with healthy people.”
The FDA and global health agencies are fervently seeking ways to contain and treat the Ebola virus as it continues to spread across West African nations and isolated cases emerge in other countries, including the United States.
“We’ve called [the FDA] up and told them what we’re doing, and we’ve worked very closely with the FDA,” Erck said. “They want to see products emerge that can be effective in this outbreak.”
That sense of urgency has allowed some drugmakers and biotechnology companies to expedite safety trials. Regulators in Switzerland, for example, approved inoculating health workers traveling to Africa with an experimental vaccine developed by GlaxoSmithKline.
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