Study Confirms Side Effect of Rotavirus Vaccine
Updated: Thu, Feb 22 07:03 PM EST
NEW YORK (Reuters Health) - A new study confirms that the rotavirus vaccine does indeed increase the risk of intussusception, a rare form of intestinal blockage.
The vaccine was pulled from the market in 1999, after nine reports of intussusception occurred within the first 7 months of vaccine use, more than double the cases reported in the previous seven years, according to Dr. Trudy Murphy and associates from the National Immunization Program of the Centers for Disease Control and Prevention in Atlanta, Georgia.
Intussusception occurs when the intestine telescopes into itself, causing an obstruction of the bowel that is repaired surgically. During the studies to support licensing of the rotavirus vaccine, only 5 cases of intussusception were reported among more than 10,000 infants who received the vaccine. Rotavirus is the number one cause of severe diarrhea in infants and is responsible for countless visits to the doctor's office and, sometimes, the emergency department.
An investigation of vaccinated infants confirms that the vaccine was indeed the cause of the complication, according to a report in the February 22nd issue of The New England Journal of Medicine
Seventy-four infants out of a total of 426 infants with intussusception had received the rotavirus vaccine, the report indicates, and most of these infants had intussusception shortly after their vaccination.
Within the first 14 days after vaccination, the risk of intussusception was 10 times higher than normal, the authors report, and within the first 7 days after vaccination, the risk was 14 times higher than normal.
If the national rotavirus vaccination program were to continue, the investigators estimate that the intussusception rate would increase by 28% to 57%, or an additional 361 to 732 cases per year.
They note that severe diarrhea caused by rotavirus leads to 500,000 office visits, 50,000 hospitalizations, and approximately 20 deaths annually in the United States.
"Rotavirus vaccines with an improved safety profile are urgently needed," the authors conclude.
SOURCE: The New England Journal of Medicine 2001;344:564-572.
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