“Cholera vaccine developed by University of Maryland wins FDA approval”
Federal regulators have approved a cholera vaccine developed by the University of Maryland that will provide U.S. travelers with the first defense against the virulent infection common in many poor countries.
The FDA approved Vaxchora this month, and its maker says it could be available as early as this fall. Research continues with the goal of expanding global protection against an infection that still sickens millions of people each year.
"Very healthy people can get very sick very quickly from cholera," said Dr. Kathleen M. Neuzil, director of the university's Center for Vaccine Development, where the vaccine was created. "This marks a significant public health milestone."
The vaccine was developed in the 1980s, but never made it to market in the United States. The Maryland center partnered with Redwood City, Calif.-based PaxVax recently to study the vaccine in humans and seek FDA approval.
Because there is little cholera in the United States, researchers infected volunteers with the bacteria in what is known as a challenge study — the first time the FDA has permitted such a plan for testing vaccines in humans. Vaxchora was found to be about 90 percent effective at 10 days and close to 80 percent effective at three months.
Those studies were completed more quickly than if researchers had to wait for study subjects to become infected in the environment, said Dr. Wilbur H. Chen, chief of the vaccine center's adult clinical studies section, who led the human studies. That helped to win FDA approval in about seven years, or half the time that might have been expected, he said.