The FDA's notification was announced on February 14 following 28 after market reports of infants who have developed intussusception, which can cause an obstruction in the intestines. The discovery made from these 28 reported pediatric cases all occurred after full-dose vaccinations were given.
Of the 28 cases reported, 16 infants have been hospitalized who also required intestinal surgery as a result of intussusception. The other 12 case reports have not required surgical intervention. No deaths have been reported as a result.
RotaTeq is a liquid oral vaccine, given by mouth in three doses, between the ages of 6 years and 32 weeks.
Almost 50 percent of the reports occurred within 1 to 21 days after the full 3-dose vaccination was administered.
The FDA previously issued approval of the fairly new vaccine to prevent rotavirus gastroenteritis in infants just slightly more than 1 year ago on February 3, 2006. This is the only approved vaccine in the U.S. to help prevent the rotavirus viral infection.
When the FDA approved the vaccination, Dr. Jesse L. Goodman from the FDA's Center for Biologics Evaluation and Research, stated, "This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life."
According to the Centers for Disease Control and Prevention (CDC) the rotavirus infection is a leading cause of severe diarrhea in infants and young children internationally. It was also estimated in 2006 that the rotavirus infection resulted in approximately 55,000 annual hospitalizations of infants and young children in the U.S. alone. However, death from the virus is rare within the U.S.
The FDA advises parents to contact their healthcare provider if their child develops potential signs of the condition at any time after vaccination. These signs include stomach pain, vomiting, diarrhea, blood in the stool, or a change in bowel movements.
Healthcare professionals are asked to help assist the FDA and the CDC by reported any cases of intussusception or other adverse reports of potential risks associated with the rotavirus vaccine.
The FDA notes that additional cases may have occurred that have not been reported.
It is also possible that the use of a previously approved and later withdrawn rotavirus vaccine named RotaShield manufactured by Wyeth may have caused an increase in these intussusception incidences, according to the FDA.
There have been approximately 3.5 million doses manufactured in the one year since approval was established, but not all of these doses have been administered to patients.
There are current after market studies in progress to further assess the safety of the vaccine, according to the FDA.
