Tuesday, August 3, 2004

Mexico approves vaccine



By Matt Leingang
Enquirer staff writer

Children in Mexico are the first to benefit from a new vaccine against severe childhood diarrhea that was developed by researchers at Cincinnati Children's Hospital Medical Center.

The Mexican government approved the rotavirus vaccine July 12, Children's Hospital announced Monday.

It's the first major vaccine developed in many years at Children's Hospital, where Dr. Albert Sabin developed an oral polio vaccine in the 1950s.

Rotavirus, much more deadly in developing countries, kills up to 600,000 children worldwide each year. In the U.S., rotavirus infection hospitalizes 50,000 children a year and causes 20 to 40 deaths.

The disease is caused when children swallow trace amounts of fecal matter. Infected children have severe bouts of vomiting and diarrhea and can die of dehydration.

Mexican officials are seeking $30 million to make the rotavirus vaccine part of a massive child immunization program in April.

Clinical trials have shown the vaccine, which is taken orally, to be 90 percent effective in preventing rotavirus disease.

Research on the vaccine began at Children's Hospital in 1989. About 60,000 children, including 250 in Greater Cincinnati, participated in clinical trials.

"This vaccine wouldn't have been possible without these volunteers, who participated for the good of mankind," said Dr. David Bernstein, who co-discovered the vaccine with Dr. Richard Ward.

Children's Hospital holds the patent for the vaccine, a live, weakened strain of the rotavirus originally dubbed "89-12." The vaccine was licensed to Avant Immunotherapeutics Inc. and its partner, GlaxoSmithKline, which will market it under the name Rotarix.

GlaxoSmithKline is not seeking to license the vaccine in the United States, Bernstein said.

Instead, the company has decided to take it to Latin America and the rest of the Third World, where it is needed most, Bernstein said.

"A lot of people don't know this disease, but it can be pretty severe," said Dr. Marc Richardson, a pediatrician in Fairfield who typically sees about 30 to 40 cases a year.

Generally, doctors let the virus run its course and children get better on their own. But it in severe cases, children require hospitalization, Richardson said.

The only U.S.-licensed rotavirus vaccine was pulled from the market in 1999 after it was discovered that some babies developed an intestinal obstruction called intussusception shortly after immunization.

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E-mail mleingang@enquirer.com




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