Officials At Alabama Dispensed More Vaccine Against Rotavirus That Is Subject Of FDA Health Notification. Alabama’s Department of Public Health has dispensed more than 50,000 doses of an early childhood vaccine that is the subject of an FDA public health notification about intestinal problems in infants, an official said Wednesday.
Winkler Sims, head of the state Department of Public Health’s immunization division, said the state began distributing the RotaTeq vaccine in July to more than 500 sites that participate in the Children’s Vaccine Program. Private providers also have been using the vaccine, with 3.5 million doses distributed nationwide over the past year.
Sims said the state will continue routinely injecting children with RotaTeq because the Food and Drug Administration has not determined that it is unsafe. The vaccine protects children against a rotavirus, which is the leading cause of childhood diarrhea.
“At this point there’s no recall on the vaccine,” Sims said. “It’s just a warning for physicians.”
Several Reports Of Intussusception Since The Vaccine Was Approved
The FDA notified health care providers and consumers that there have been 28 reports of a serious intestinal condition called intussusception in infants since the vaccine was approved last February. The FDA said it was unknown whether the vaccine caused the problem, and said that number of cases was below what authorities would expect to occur naturally each year.
But eight years ago, a high number of intussusception cases led to withdrawal of the first rotavirus vaccine. There were no deaths reported in the 28 new cases of intussusception, but 16 infants did require intestinal surgery, the FDA reported.
The FDA wants vaccine providers to report all cases of intussusception to the Vaccine Adverse Events Reporting System.
To gain FDA approval, RotaTeq, which is manufactured by Merck & Co. Inc., passed safely through a trial of 70,000 infants. To further confirm the vaccine’s safety, Merck is conducting another study of 44,000 infants, and the CDC Vaccine Safety Data Link is conducting a study 90,000 infants, according to the FDA.
RotaTeq requires three doses. Some of the cases of intussusception occurred after the first dose, some after the second and some after the third. About half the cases occurred one to 21 days after one of the vaccinations; no cases were reported later than 73 days after a vaccination.
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