Monitoring of Intussusception after RotaTeq Vaccination

Each year in the United States, rotavirus is responsible for more than 400,000 doctor visits, more than 200,000 emergency department visits, 55,000 to 70,000 hospitalizations, and between 20 and 60 deaths among children less than 5 years of age. In 2006, FDA licensed RotaTeq, a new rotavirus vaccine. CDC's Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of U.S. infants with three doses of RotaTeq given orally at ages 2, 4, and 6 months.

CDC and the Food and Drug Administration (FDA) conduct routine safety monitoring for new vaccines. In 2006, CDC implemented a post-licensure vaccine safety study of the RotaTeq vaccine. Because the previous rotavirus vaccine was withdrawn from the U.S. market due to an association with intussusception (a type of bowel obstruction), this study looked for evidence of a possible link between RotaTeq and intussusception.

Study Methods

Scientists analyzed the data from reports of intussusception after RotaTeq vaccination using data from CDC's Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD) Project.

• VAERS reports of intussusception after RotaTeq vaccination were reviewed and intussusception diagnoses verified; if they met the Level 1 criteria in the Brighton Collaboration case definition, they were considered confirmed.



• Children who were vaccinated with RotaTeq between 4 and 48 weeks of age at any of the six managed care organizations (MCOs) that submitted data to VSD were watched for intussusception for 30 days after vaccination.



• Data from the RotaTeq clinical trial and the VSD Project were combined to assess risk in a 3–7 day window after vaccination. The 3–7 day window was the period of the greatest risk of the previous vaccine.



• Scientists calculated the expected number of cases that the VSD and the pre-licensure clinical trial would have identified if RotaTeq had an intussusception risk.

VAERS Reports Related to RotaTeq and Intussusception February 1, 2006 through September 25, 2007

VAERS received 1,901 reports of adverse events after RotaTeq vaccination between February 1, 2006 and September 25, 2007; a total of 160 intussusception reports were confirmedObserved Versus Expected Calculations

Scientist observed in VAERS data 47 intussusception cases (29%) occurred during the first 21 days after vaccination, including 27 intussusception cases (17%) during the first 7 days after vaccination. From VSD data, the expected number of intussusception reports was 151 cases during the first 21 days after vaccination, including 50 cases during the first 7 days after vaccination.

Please note: In comparison to the previous rotavirus vaccine, more than 60% of the intussusception cases occurred between 1 and 7 days after vaccination.

Based on scientific assumptions from the actual vaccine doses distributed, estimated 75% of the intussusception cases that occurred during these time periods were reported to VAERS and that 75% of the vaccine doses distributed were administered, the observed rate of intussusception was not higher than the age-adjusted background rate of intussusception.

VSD Project Data May 21, 2006 through September 25, 2007

The administrative, computerized data submitted by participating MCOs to the VSD Project showed that 111,521 doses of RotaTeq were given to infants enrolled in participating MCOs. There were 3 cases of intussusception following vaccination: 1 case after dose 1 on day 20, and 2 cases after dose 2 on days 10 and 17.

Study Limitations

The data used in this study have several limitations. First, we don't know how many cases of intussusception following RotaTeq vaccination were not reported to VAERS, and thus were not included in this study. Second, we don't know how many of the RotaTeq vaccines that were distributed were actually given. Third, the calculated background rates of intussusception based on the VSD data may not represent the general population, on which the VAERS data are based.

Conclusions

Available data do not indicate that RotaTeq is associated with intussusception. With more than 9 million doses of vaccine distributed during the first 19 months after licensure, data from VAERS and the VSD Project do not associate RotaTeq with intussusception. Although an intussusception risk similar in magnitude to that of the previous vaccine can be excluded, continued monitoring is necessary to assess RotaTeq's safety completely.

Related Links

Rotavirus Vaccination
The rotavirus vaccine currently licensed in the United States, Rotateq, has shown to be quite effective against rotavirus disease.

Intussusception: Questions & Answers
Intussusception is an uncommon type of bowel obstruction that occurs when the bowel folds in on itself. It is most common among young children.

Kawasaki Syndrome and RotaTeq Vaccine
The FDA approved a revised label for RotaTeq to include information on reports of Kawasaki syndrome occurring before and after the vaccine's licensure in February 2006.

Related Scientific Articles

1. Centers for Disease Control and Prevention (CDC). Intussusception among recipients of rotavirus vaccine—United States, 1998–1999. MMWR 1999;48(27):577–581.



2. Centers for Disease Control and Prevention (CDC). Withdrawal of rotavirus vaccine recommendation. MMWR 1999;48(43):1007.



3. Kramarz P, France EK, Destefano F, Black SB, Shinefield H, Ward JI, Chang EJ, Chen RT, Shatin D, Hill J, Lieu T, Ogren JM. Population-based study of rotavirus vaccination and intussusception. Pediatric Infectious Disease Journal 2001;20(4):410–416.



4. Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW, Wharton M, Livengood JR; Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine.* New England Journal of Medicine 2001;344(8):564–572.



5. Parashar UD, Alexander JP, Glass RI. Prevention of rotavirus gastroenteritis among infants and children: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR–12):1–13.



6. Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M. Intussusception among recipients of rotavirus vaccine: reports to the Vaccine Adverse Event Reporting System. Pediatrics 2001;107(6):E97.

To read the full article, please go to PEDIATRICS.

CDC encourages health care providers and others to report cases of adverse events following vaccination to VAERS. For a copy of the vaccine reporting form, call (800) 822-7967 or visit VAERS.

*Links to non-Federal organizations found at this site are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. CDC is not responsible for the content of the individual organization Web pages found at these links.