RotaTeq gained FDA approval in February 2006 and is manufactured by Merck. At the time, the FDA and Merck said trials of the vaccine involving approximately 70,000 infants indicated it did not increase the risk of intussusception. But Merck and the Centers for Disease Control and Prevention are conducting follow-up studies of tens of thousands more infants to track any long-term effects of the vaccine. The FDA is monitoring reports additionally. About 3.5 million doses of the Merck vaccine have been dispersed in the U.S., though not all have been used, the FDA said.
On February 13, 2007 the U.S. government issued a warning for a potentially life-threatening condition called Intussusception that causes the twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea. Intussusception originally led to the withdrawal of the first rotavirus vaccine eight years ago. The FDA said it was not know yet whether the newly approved vaccine, called RotaTeq, caused the 28 new cases.
The reports don’t surpass the numbers expected to occur naturally each year, the so-called background rate, the FDA said. With this public health notification, the agency said it wanted in part to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess any risks associated with the three-shot vaccine series. It also said the vaccine’s label would mention the cases of intussusception. “It’s a known serious, life-threatening adverse event that is being seen at an expected level post marketing. But because it is so serious, we asked the company to change the label,” FDA spokeswoman Karen Riley said. The 28 cases included 16 infants who needed intestinal surgery. To date there have been no reports of deaths.
It looks like this is the natural background rate that we are seeing,” said Dr. Michelle Goveia, medical director for pediatric medical affairs at the vaccine’s manufacturer, Merck & Co. Inc. Goveia suggested heightened concerns about the previous vaccine, made by Wyeth, prompted the FDA to act. The earlier rotavirus vaccine, Wyeth’s RotaShield, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception. It had been on the market a year.
Legal Help For Victims Affected By RotaTeg
If your child was given the vaccine Rotateq and suffered Intussusception, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).