Rotavirus vaccine given the green light

Feb 22 2006

The Food and Drug Administration in the U.S. has recommended a new vaccine for routine use against rotavirus infection.

Rotavirus is a common childhood illness; it is the single largest infectious disease killer of infants and young children worldwide.

The new vaccine is manufactured by Merck & Co and was developed by three scientists associated with the Children's Hospital of Philadelphia and the Wistar Institute.

Almost all children at some point are affected by Rotavirus, often with only mild symptoms, but some children suffer severe and potentially life-threatening diarrhea and dehydration.

Rotavirus is responsible for tens of thousands of hospitalizations in the U.S. each year, and hundreds of thousands child deaths throughout the world.

The new vaccine was invented by three Philadelphia scientists: H. Fred Clark, D.V.M., Ph.D.; Paul A. Offit, M.D.; and Stanley A. Plotkin, M.D., all of whom led laboratory studies of the vaccine at the Children's Hospital of Philadelphia and the Wistar Institute between 1980 and 1991.

Dr. Offit is currently chief of Infectious Diseases, Maurice R. Hilleman Endowed Chair in Vaccinology, and director of the Vaccine Education Center at The Children's Hospital of Philadelphia.

Dr. Clark is a research professor of Pediatrics at Children's Hospital, and Dr. Plotkin, an emeritus professor at Wistar and a former director of Infectious Diseases at Children's Hospital, developed a number of previous vaccines, including the vaccine that has eradicated rubella (German measles) in the United States.

Steven M. Altschuler, M.D., president and chief executive officer of the Children's Hospital of Philadelphia, says the vaccine is the culmination of decades of work and brings closer the ultimate goal of eliminating childhood disease.

In the United States, children under age five experience an estimated 2.7 million episodes of rotavirus gastroenteritis each year, resulting in 250,000 emergency room visits and an estimated 70,000 hospitalizations.

In developing countries, where appropriate medical care may be unavailable, rotavirus kills as many as 600,000 children annually.

Clinical trials of RotaTeq on more than 70,000 infants in 11 countries was apparently one of the largest clinical trials to be performed by a pharmaceutical company.

The resulting data showed that the vaccine prevented 98 percent of severe cases of rotavirus gastroenteritis and 74 percent of routine cases, compared to a placebo.

The vaccine showed no increased risk of intussusception, a telescoping of the bowel that had been associated with a previous, discontinued rotavirus vaccine produced by another manufacturer in the 1990s.

The new vaccine is at present the only one available in the U.S. to prevent rotavirus gastroenteritis.

It is given by mouth, in three doses,at ages two, four and six months.

Merck has said it is committed to making the RotaTeq vaccine available to infants and children worldwide.