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On February 13, 2007, the FDA issued a public health notification that 28 cases of intussusception had been reported after administration of RotaTeq since its licensure in February 2006. No deaths were reported. Cases occurred up to 73 days after administration of one of the three doses of the vaccine; about half occurred within the first 21 days after vaccination. To date, about 3.5 million doses of RotaTeq have been distributed in the U.S., although the number of administered doses is not known. The number of reported intussusception cases is less than the CDC’s estimated background rate (18–43/100,000 children aged 6–43 weeks).
Comment
The FDA states that this notification is intended to encourage reporting of future ca…