The announcement last week of a new AIDS vaccine developed at Yale added ammunition to the fight to end the world’s AIDS epidemic. But the fate of the drug and whether it will actually reach the developing world where it is needed most is in the hands of Yale and the company that owns the rights to produce it.
The new AIDS vaccine, developed by a team led by Dr. John Rose at the School of Medicine, is considered by some AIDS experts to be the most promising because it is the most-easily administered and least expensive of all others undergoing testing. Jon Soderstrom, the managing director of the Yale Office of Cooperative research, said Yale has filed a patent application on the vaccine and has licensed the right to develop the drug to Wyeth-Lederle, a division of corporate giant American Home Products.
The controversy earlier this year over the antiretroviral AIDS drug d4t that was developed at Yale and licensed to Bristol-Myers Squibb is an ominous sign for the future of Rose’s vaccine. After years of placing high prices on the drug that made it nearly unavailable in the developing world, Yale finally began negotiations with pharmaceutical giant Bristol-Myers Squibb last March to make the drug available for generic production in South Africa. Rose’s AIDS vaccine may too be effectively kept out of the developing world unless Yale can prevent a replay of the situation over d4t.
While other vaccines must be given several times via injection, Rose’s new vaccine, proven effective in monkeys so far, is given in the form of a nasal spray only once or twice. In places like sub-Saharan Africa where nearly 10 percent of the population is infected with HIV and it is difficult to get people to return for multiple injections, such an easy method of vaccination could be the only way to effectively end the epidemic.
Though the vaccine will be relatively inexpensive to manufacture, testing it will be very costly, Rose said.
Because Rose’s vaccine is a live virus that must be tested on healthy individuals, it will take at least four years of expensive clinical testing before the vaccine hits the market. The lengthy testing process could cost Wyeth-Lederle billions of dollars, Rose said. Rose said that even if Wyeth-Lederle charges high prices for the vaccine to pay for its years of testing, it is the responsibility of governments to pay such prices for the drug.
“If a company spends billions of dollars to develop something then it can’t be expected to give it away for free,” Rose said. “The price of safety testing is immense for pharmaceutical companies and the cost of the drugs should be minimal in terms of a country’s gross national product.”
Wyeth-Lederle did not return calls made over the weekend.
Yale President Richard Levin said that from the controversy over Bristol-Myers Squibb’s d4t drug pricing in the developing world the University learned that it might be sensible to vary the price of the drug in different countries. He added that Yale would look into differential pricing for the new AIDS vaccine.