MEXICO CITY -- A new vaccine against the rotavirus, which can cause fatal illness in children, is being launched this week in Mexico rather than in the developed world, marking a sea change in how major companies market drugs worldwide.
This is the first time a drug company has sidestepped US and European regulators, allowing it to get out the drug in time for the peak infection season in one region where the disease is deadliest, and to beat competitors working on similar vaccines.
Heralded as a public health breakthrough that could significantly dent child mortality, the vaccine's global launch in Mexico sets a new model for bringing such remedies first to poorer populations often ravaged by preventable diseases.
The drug giant is changing a pattern of vaccine development in which products are traditionally introduced in the United States and Europe and then sold in poor nations. This new scheme could apply to drugs for malaria and AIDS, for example.
"The experience in Mexico will be very important for the public health impact but also to inform decision makers in poor countries in Latin America and around the world," said Dr. John Wecker of the US-based, nonprofit Rotavirus Vaccine Program.
The fight against rotavirus was set back in 1999, when a vaccine sold in the United States by Wyeth was pulled because of fears it could cause a sometimes deadly bowel obstruction.
A link was not proven, and some specialists say the death rate from rotavirus among the poor outweighs the vaccine's risks.
But company executives and Mexican health officials say Rotarix underwent some of the largest safety trials ever, partly as a result of the scare, and faced a rigorous approval process in Mexico. The US Food and Drug Administration declined to comment.
The highly infectious rotavirus can cause severe diarrhea and vomiting, leading to dehydration. It kills 400,000 to 600,000 children a year, 85 percent of them in developing nations. Some 1,000 children die from it in Mexico every year.