Health

Alert

INTUSSUSCEPTION AND ROTAVIRUS (RotaTeq®) VACCINE

The Delaware Division of Public Health (DPH) is alerting the Delaware medical community of the Food and Drug Administration (FDA) notice

about reports of intussusception following administration of Rotavirus vaccine (trade name RotaTeq®).

No known cases associated with vaccine administration are known to have occurred in Delaware.

Intussusception is a serious, life-threatening condition that occurs when the intestine or bowel becomes blocked. One portion of the

intestine telescopes into a nearby portion, causing the obstruction. This leads to inflammation, swelling and eventually decreased blood

flow. With prompt detection and treatment, almost all patients fully recover. Although persons of any age can get intussusception, it is

most common among infants in the first year of life.

Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may

have been caused by the vaccine, or occurred by coincidence, is unknown. The number of intussusception cases reported to date after

RotaTeq® administration does not exceed the number that would be expected to occur without vaccination. Although the data received so

far suggests that RotaTeq® does not cause intussusception, it is possible that because of incomplete reporting of cases and other

factors, some increased risk of intussusception associated with RotaTeq® vaccination could yet be found.

This notice does not mean there is a problem with the RotaTeq® vaccine and CDC is not changing its policy at this time. CDC continues

to support the Advisory Committee on Immunization Practices’ (ACIP) recommendation for routine immunization of all U.S. infants

with three doses of RotaTeq® administered orally at ages 2, 4 and 6 months.

CDC and FDA are continuing to carefully monitor reports of possible adverse effects of the vaccine and encourages all healthcare

providers and other individuals to report any cases of intussusception or other severe adverse events following immunization with

RotaTeq®) to VAERS (Vaccine Adverse Events Reporting System).

For more information, call the Immunization Program at 1-800-282-8672 or go to the CDC website for more information at: http://www.cdc.gov/od/science/iso/concerns/rotavirus.htm