New rotavirus vaccine close to launch in Mexico

1.00pm

MEXICO CITY - A new vaccine against rotavirus, one of the world's chief killers of children, is due to be launched in Mexico as soon as this year and will mark a sea change in how major companies market drugs worldwide.

GlaxoSmithKline submitted its oral vaccine Rotarix to Mexican authorities for approval and conducted clinical trials with more than 60,000 children in one of the largest such studies ever, Dr Bruce Innis, vice president for Latin America research and development at GSK, said in a telephone interview on Monday.

In launching the vaccine in Mexico, the company "reverses the history of vaccine development in the last 50 years, in which new products are introduced in the United States and Europe and then to the developing world," Innis said.

"For the first time a manufacturer has made an effort to make a new vaccine available in the countries where the disease burden is the greatest," he said.

Introduction of the vaccine, five years after another was withdrawn owing to health concerns, would be a major step toward saving hundreds of thousands of lives, experts say.

"If we have a vaccine this will be a major breakthrough," said Dr Ciro de Quadros, an authority on rotavirus at the nonprofit Sabin Vaccine Institute in Washington.

The highly infectious disease can cause severe vomiting and diarrhoea leading to dehydration. It kills 400,000-600,000 children a year worldwide, mainly in developing countries. Some 15,000 children die from it in Latin America every year.

Almost every child is exposed to rotavirus by age five. However, 82 per cent of rotavirus deaths occur in less developed countries, where children have limited access to health care and often arrive at the clinic too late.

GSK has spent some US$500 million ($781 million) to develop Rotarix. Landmark research on rotavirus by Mexican investigators helped inspire the manufacturer to launch the vaccine here.

GSK will present results of its Rotarix trials at a forum this week in Mexico City, when some 300 health ministers, public health workers, scientists and pharmaceutical companies meet to review progress in the fight against rotavirus.

Mexico and other nations have battled deadly diarrhea with hygiene and sanitation programmes. But such measures are less successful against rotavirus.

"If sanitary measures are not sufficient, the most important way to control it is the vaccine," said Romeo Rodriguez, head of Mexico's child health office.

In 1998 a rotavirus vaccine marketed in the United States by Wyeth was withdrawn for fears it could cause a sometimes deadly bowel obstruction.

That caused governments worldwide to reject a remedy that might have saved many lives, experts say. And manufacturers now had to conduct much larger safety trials for new vaccines.

Besides GSK, today Merck and Co is also testing a new vaccine and will report at the Mexico forum.

Any new vaccine will be relatively expensive, but international health leaders like De Quadros hope to bring it to poor people around the world, the populations most at risk.

Mexico will study the cost-effectiveness of including it in routine child immunisation while it enters the private sector.

Honduras, one of the poorest countries in the hemisphere, and other Latin American nations are working to make the vaccine part of public health systems.

"The major challenge is how the vaccine could be introduced in the public sector, and that's one of the things we hope will come out of this meeting ... so that the majority of children will benefit," De Quadros said.

- REUTERS