On Friday, Merck received FDA approval for its new oral rotavirus vaccine, RotaTeq, and will begin domestic distribution within a week. At a cost of $187.50 for the three-dose series, RotaTeq is one of the most expensive vaccines to date; by 2009, the company forecasts that the vaccine could bring in as much as $500 million in annual revenue.
RotaTeq could prove particularly useful in the developing world. While deaths in the United States are rare, the disease is estimated to claim the lives of more than 500,000 children across the globe, making it one of the world's deadliest childhood illnesses, said Dr. Umesh Parashar, a medical officer in the respiratory and enteric viruses branch of the Centers for Disease Control and Prevention.
World health officials greeted news of RotaTeq's approval with cautious enthusiasm, but they said they did not know how they would pay for it or whether they would try.
Dr. Marie-Paule Kieny, director of the initiative for vaccine research at the World Health Organization, said Merck needed to test the drug in poor nations before the W.H.O. would recommend its universal use.
Some oral vaccines that perform well in rich countries are not nearly as effective in poor ones, Dr. Kieny said.
A global vaccine initiative, financed in part by Bill Gates, is already struggling to deliver worldwide a $3.50 vaccine against five other major killers. Adding RotaTeq to the mix may be impossible, Dr. Kieny suggested, even with steep discounts.
"The money is simply not there," she said.
Merck officials said that they were committed to making RotaTeq available at a discount in the developing world but that such an initiative was years away. A test of RotaTeq in poor nations is in the planning stages, they said.