WASHINGTON – The National Institutes of Health may grant a Rockville-based company the exclusive right to produce a human vaccine that the agency is developing for the West Nile virus.
The license will be awarded to MacroGenics unless there are protests during the 60-day comment period that began Friday, when the proposal was published in the Federal Register, said officials familiar with the process.
There are currently no approved vaccines for West Nile virus, which has spread rapidly throughout North America since it was first detected in the United States in 1999.
The Centers for Disease Control and Prevention said that, as of Feb. 11, there were 9,136 confirmed cases of West Nile virus and 228 deaths reported for 2003 in 45 states and the District of Columbia. Maryland reported 73 cases and six deaths for 2003.
The vaccine under study at NIH would mix parts of dengue, a tropical virus of the same family, with parts of the West Nile virus to produce a safer vaccine than possible with the genes from the West Nile virus alone.
“Using the dengue backbone, they’ve taken out the gene that makes it (the vaccine) pathogenic, so it’s attenuated,” said Joe Panigot, a spokesman for MacroGenics. “You don’t what the person you are vaccinating to have a serious infection.”
The vaccine has performed well in monkey trials, according to NIH. In August, NIH scientists reported the findings of an experiment in which all the monkeys injected with the vaccine developed the antibodies needed to fight off a West Nile virus infection.
Human trials for the vaccine are expected to begin this year, according to NIH.
The federal government usually prefers to have competition among vaccine manufacturers, but is considering an exclusive grant to MacroGenics because the market for a West Nile virus vaccine is so small, said Peter Soukas, a licensing specialist for NIH.
“It’s very difficult for businesses to raise the capital to take a vaccine like this through the clinic (clinical tests) and the eventual registration,” with the Food and Drug Administration, Soukas said.
He said that it costs about $1 billion to get a vaccine — like one for the West Nile virus — through the whole government-approval process.
Barring complaints, Soukas said he expects the license will be granted to MacroGenics. Panigot said the 3-year-old firm has several drugs in development that are aimed in boosting immune systems, but it currently has no products on the market.
-30- CNS 02-13-04