FDA Notes Baby Vaccine Bowel Problems
Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
Reported Cases continued...
Those studies showed "no significant increased risk of intussusception," notes an FDA public health notice.
The FDA also says that "the number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected," based on unpublished CDC data.
According to the FDA, about 3.5 million doses of RotaTeq had been distributed in the U.S. through Feb. 1, 2007, but not all of those doses have been administered.
The 28 intussusception cases were reported after the first, second, and third doses of the vaccine. The cases occurred within 73 days after getting any of those doses; roughly half of the cases happened within 21 days.
The FDA's Past Comments
When the FDA approved RotaTeq just over a year ago, the FDA's Jesse Goodman, MD, MPH, called data from the vaccine's preapproval studies "reassuring."
But Goodman, who directs the FDA's Center for Biologics Evaluation and Research, also said at the time that "people would need to consider that [the studies] are not conclusive that this side effect could not potentially occur" and that the FDA had put in place "an extremely aggressive program to try to get as much information about the vaccine in its early period of use as possible."
Further studies are being done to probe the risk of intussusception and other serious events with RotaTeq.
RotaTeq's maker, the drug company Merck, is conducting a postmarketing study of approximately 44,000 infants. The CDC is doing its own study of about 90,000 infants, says the FDA. Merck is a WebMD sponsor.
WebMD contacted Merck for the company's comments.
In a news release emailed to WebMD, Merck states that intussusception is "a naturally occurring event in infants" that is estimated to occur in approximately one in 2,000 infants during the first year of life.
"Cases of intussusception can occur when no vaccine has been given, and the cause is usually unknown," Merck states.
The news release also includes comments from Mark Feinberg, MD, PhD, vice president of policy, public health, and medical affairs for Merck Vaccines.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," Feinberg says, in the news release.
Feinberg says public health and patient safety are Merck's "highest priorities" and that Merck is "very confident" in the data supporting RotaTeq's safety profile from its preapproval study.
RotaShield, the vaccine that was withdrawn from the market in 1999, was made by the drug company Wyeth.
Wyeth is a WebMD sponsor.