arizona republic
week of oct 23, 1999 - stupid webmaster lost article after scan
U.S. flips on vaccine
Drug.. for infants tied to bowel ill
By Lawrence K. Altman
New-York Times
In a rare And embarrassing reversal, a federal health advisory panel Friday withdrew its recommendation that all infants be immunized against the virus that causes a severe form of diarrhea after the vaccine was linked to a painful and potentially fatal bowel obstruction.
The action comes a year after the government licensed the rotaviirus vaccine, and three months after it. abruptly suspended its use because of reports that some babies who took it were coming down with the bowel condition. A week ago the manufacturer, American Home Products of Madison, N.J., withdrew the vaccine from the market.
Friday, the Federal Centers for Disease Control and Prevention said new scientific studies showed that the vaccine, Rotashield, appeared to cause the bowel obstruction in about I in 5,000 recipients.
Despite the suspension in July, the advisory panel's formal position until Friday had been that all infants in the United States should receive
three doses of the vaccine, at 2, 4 and 6 months of age. Rotashield is the world's first and only licensed vaccine against rotavirus, though it is not being used in other countries.
Friday's action was taken by a committee appointed by the secretary of Health and Human Services and known as the Advisory Committee on Immunization Practices to the CDC. It is led by Dr. John F. Medlin of Dartmouth Medical School.
Of the panel's 12 members, only four voted, all for the recommendation; others were absent because of emergencies or abstained because of ties to the manufacturer or other conflicts of interest, a centers spokeswoman said. Three representatives of government health agencies who were present also endorsed the recommendation.
Dr. John Livengood, an official with the disease centers' immunization program, said in an interview that the panel's vote reflected a stepped-up review of scientific evidence "from a variety of sources, all of which showed a strong causal association" between the rotavirus vaccine and the bowel condition, intussusception.
The condition, rare in the UnitedStates, results when a section of bowel slides, inward, like a tele
scope, into another section. The new studies found that intussusception usually began three to seven days after vaccination with Rotashield.
The disease centers received reports of 102 confirmed or strongly suggestive cases of intussusception. There was a strong increase in such cases within three to seven days after the first or second dose, Livengood said; vaccinated babies were 25 times as likely to develop intussusception in the three to seven days after the first dose as those who did not receive it. The risk was not increased after the third dose.
Friday's action applies only to the United States, and Rotashield may yet be used in other countries. Around the world, rotavirus is the most common cause of severe gastroenteritis in infants and young children, and it is said to be the biggest killer of children, causing 600,000 to 800,000 deaths a year.
In the United States, by contrast, it causes just 20 deaths a year, although it is also responsible for 50,000 hospitalizations and 500,000 visits to a doctor.
In the panel discussions Friday, there was concern that the decision not be seen as closing the door on use of Rotashield in Third World countries, where rotavirus diarrhea is more -severe, Livengood said.