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Information Pertaining to Labeling Revision for RotaTeq

June 15, 2007

Today, FDA approved a revised label for Merck's vaccine to prevent rotavirus infection, RotaTeq, to include information on Kawasaki disease. The Kawasaki disease finding is contained in the Biologics License Application (BLA). In addition, three reports of Kawasaki disease in children receiving routine pediatric vaccines, including RotaTeq, were detected through routine monitoring of the Vaccine Adverse Event Reporting System (VAERS). There is not a known cause and effect relationship between receiving RotaTeq, or any other vaccine and the occurrence of Kawasaki disease. The cases reported to date are not more frequent than what could be expected to occur by coincidence. Healthcare practitioners and parents should remain confident in using RotaTeq.

FDA has not made any changes to the Indications for Use of RotaTeq, nor has the Agency issued new or revised Warnings or Precautions. The available data support the safety of the vaccine and its effectiveness in preventing rotavirus infection, a common cause of severe infant diarrhea and hospitalization. Each year in the United States, rotavirus is responsible for more than 400,000 doctor visits; more than 200,000 emergency room visits; 55,000 to 70,000 hospitalizations; and between 20 and 60 deaths. RotaTeq continues to be the best way to protect a child against rotavirus disease.

FDA and the Centers for Disease Control and Prevention (CDC) will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.

This communication is intended to make healthcare professionals and consumers aware of the newly revised label. Additional information concerning RotaTeq, changes to the label, and Kawasaki disease can be found below.

Key Facts

  • RotaTeq is the only licensed vaccine in the United States for prevention of rotavirus gastroenteritis in infants, an infection that may cause severe diarrhea, vomiting, fever and dehydration. RotaTeq is the best way to protect a child against rotavirus disease. In clinical trials that studied almost 7,000 infants from the United States and Finland, RotaTeq prevented 74% of all rotavirus gastroenteritis cases and 98% of the severe cases. In addition, RotaTeq reduced the need for hospitalization for gastroenteritis due to rotavirus by 96%.
  • The Indications and Use of RotaTeq have not changed and no new or revised Warnings or Precautions have been issued. The available data support the safety and effectiveness of RotaTeq.
  • The Adverse Reactions section of the label has been updated to specifically include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial and these data were included in the original BLA submission. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. Additionally, the Post-marketing section of the label has been revised to reflect three reports of Kawasaki disease to VAERS since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.
  • As of early June 2007, CDC's Vaccine Safety Datalink (VSD) Project reported one unconfirmed case of Kawasaki disease occurring within 30 days of RotaTeq vaccination among 65,000 doses administered to children less than 1 year of age who are enrolled in the VSD Project. This case is in addition to the three reports of Kawasaki disease made to VAERS. This finding does not represent an increased risk over what would be expected to occur among children less than 1 year of age who did not receive RotaTeq. The VSD project is a collaboration between CDC and eight managed care organizations for the purpose of monitoring the safety of vaccines administered to enrolled patients. VSD will continue to monitor for Kawasaki disease following RotaTeq administration.
  • Approximately 6 million doses of RotaTeq have been distributed in the United States through June 8, 2007. Since licensure in 2006, the three reports of Kawasaki disease to VAERS does not exceed the number of cases we expect to see based on the usual occurrence of Kawasaki disease in children.
  • Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. It impacts approximately 4,000 children each year in the United States; eighty percent of whom are younger than 5 years of age. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.
  • FDA is working with Merck, the manufacturer of RotaTeq, and the Centers for Disease Control and Prevention to further study the occurrence of Kawasaki disease after vaccination.
  • FDA encourages all healthcare providers and other individuals to report any cases of Kawasaki disease or other severe adverse events to the Vaccine Adverse Event Reporting System (VAERS). For a copy of the vaccine reporting form, call 1-800-822-7967 or report online to www.vaers.hhs.gov
 

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