Rotavirus VaccineAll links below open in new window. Food and Drug Administration Approves New Vaccine to Prevent Gastroenteritis Caused by RotavirusApril 3, 2008 -- The U.S. Food and Drug Administration (FDA) today announced the approval of Rotarix®, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix® is a liquid, given in a two-dose series to infants from 6 to 24 weeks of age. (FDA Press Release) Rotateq® Label ChangeThe Food and Drug Administration (FDA) approved a revised label on June 15, 2007, for RotaTeq®, a rotavirus vaccine manufactured by Merck and Co., Inc. (http://www.fda.gov/cber/products/rotateq.htm), to include information on reports of Kawasaki disease occurring before and after the vaccine's licensure in February 2006. The FDA has not made any changes to its indications for use of RotaTeq®, nor has it issued new or revised warnings or precautions. Likewise, the Centers for Disease Control and Prevention (CDC) has not made any changes in its recommendations regarding the use of RotaTeq®. Healthcare providers and parents should remain confident in using RotaTeq® in infants. More information is available at: http://www.cdc.gov/od/science/iso/concerns/kawasaki_ disease_rotavirus.htmCDC Reaffirms Vaccine Policy Recommendations to Routinely Vaccinate U.S. Infants With Rotavirus VaccineThe Bureau of Immunization is pleased to announce the release of the Centers for Disease Control and Prevention (CDC) report, "Postmarketing Monitoring of Intussusception After RotaTeq® Vaccination --- United States, February 1, 2006--February 15, 2007," issued on March 16, 2007 in the Morbidity and Mortality Weekly Report (MMWR). The report is available online at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5610a3.htm ?s_cid=mm5610a3_e. CDC safety data on rotavirus vaccine indicates reported intussusception cases fall within expected range. Reference: March 16, 2007 / Vol. 56 / No. 10. Rotavirus is the leading cause of severe gastroenteritis in children aged <5 years worldwide. In February 2006, a new rotavirus vaccine, RotaTeq® (Merck and Co., West Point, Pennsylvania), was licensed in the United States, and the Advisory Committee on Immunization Practices (ACIP) recommended it for routine vaccination of U.S. infants, with 3 doses administered orally at ages 2, 4, and 6 months. Because a previous rotavirus vaccine, Rotashield™ (Wyeth Laboratories, Marietta, Pennsylvania), was withdrawn from the U.S. market in 1999 after postmarketing surveillance identified an association with intussusception (a rare type of bowel obstruction), the safety of RotaTeq® was evaluated. After one year of experience with the RotaTeq® vaccine, we have no evidence of an association between the vaccine and intussusception. Intussusception, a form of bowel obstruction, is the most common cause of acute intestinal obstruction in infants aged <1 year and occurs spontaneously in the absence of vaccination. There are a number of intussusception cases that occur every year in children in the age group recommended for RotaTeq® (6-32 weeks of age), which are not related to the vaccine. Although many etiologies have been associated with intussusception (e.g., adenovirus infection or Meckel's diverticulum), the cause is often unknown. In the United States, the postmarketing safety of RotaTeq® is being monitored jointly by CDC and the Food and Drug Administration (FDA) through both evaluation of reports to the Vaccine Adverse Event Reporting System (VAERS) and active surveillance using data from the Vaccine Safety Datalink (VSD). As of February 15, 2007, postmarketing surveillance did not suggest association of RotaTeq® vaccination with intussusception. CDC reaffirms vaccine policy recommendations to routinely vaccinate U.S. infants with RotaTeq® at ages 2, 4, and 6 months. Rotavirus LinksCenters for Disease Control and Prevention KidsHealth Merck Rotavirus Vaccine Program National Network for Immunization Information Rotavirus News ArchiveThe Food and Drug Administration (FDA) has notified healthcare providers and consumers about reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq®), manufactured by Merck and Co. Inc. (www.fda.gov/cber/safety/phnrota021307.htm). This notice does not mean there is a problem with the RotaTeq® vaccine. The Centers for Disease Control and Prevention (CDC) is not changing its policy at this time. The 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 (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr 5512a1.htm?s_cid=rr5512a1_e). The FDA has issued this notification to encourage the reporting of any additional cases of intussusception that may have occurred or will occur in the future after administration of RotaTeq®. The number of intussusception cases reported to-date after RotaTeq® administration does not exceed the number we would expect to occur without vaccination. Although the data we have received so far suggests that RotaTeq® does not cause intussusception, it is possible that because of incomplete reporting of cases to VAERS and other factors, some increased risk of intussusception associated with RotaTeq® vaccination could yet be found. Thus, the CDC and FDA are continuing to carefully monitor reports of possible adverse effects of the vaccine. The CDC and FDA encourage all healthcare providers and other individuals to report any cases of intussusception or other severe adverse events to the Vaccine Adverse Event Reporting System. For a copy of the vaccine reporting form, call 1-800-822-7967 or report online at: www.vaers.hhs.gov. The CDC has further information at: http://www.cdc.gov/od/science/iso/concerns/rotavirus.htm. Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization PracticesAt the request of the Centers for Disease Control and Prevention (CDC), the Bureau of Immunization is pleased to announce the release of the MMWR (Morbidity and Mortality Weekly Report) Recommendations and Reports Volume 55, No. RR-12, August 11, 2006, "Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices (ACIP)." This report presents the ACIP recommendations for use of a live, oral, human-bovine reassortant rotavirus vaccine. In February 2006, a live, oral rotavirus vaccine (RotaTeq®) was licensed for use among U.S. infants. The Advisory Committee on Immunization Practices recommends routine vaccination of U.S. infants, with 3 doses of rotavirus vaccine administered orally at ages 2, 4, and 6 months. The first dose should be administered between ages 6 and 12 weeks. Subsequent doses should be administered at 4- to 10-week intervals, and all 3 doses should be administered by age 32 weeks. Rotavirus vaccine can be co-administered with other childhood vaccines. Access the report online at: http://www.cdc.gov/mmwr/PDF/rr/rr5512.pdf [PDF 197 KB] or http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5512a1.htm ?s_cid=rr5512a1_e. An
Interim Rotavirus Vaccine Information Statement (VIS) is
available now at: A final VIS will be available after the new VIS is developed according to legally-mandated procedures. |
||||||||||||||||||||||||||||||||||||||||||||||||
