Rotavirus Vaccine Archive
-- Superseded Infrormation -- HISTORICAL USE ONLY -- See Current Information --IMPORTANT: FDA Recommends Suspension of Rotarix® Vaccine
March 22, 2010 -- The Food and Drug Administration (FDA) recommends that healthcare practitioners temporarily suspend use of the Rotarix® vaccine for rotavirus immunization in the U.S. while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
Routine testing of Rotarix® vaccine by an independent U.S. academic research team detected PCV1 genetic material (Porcine Circovirus 1) in the vaccine. PCV1 is not known to cause illness in humans or other animals. Rotarix® has been studied extensively and found to have an excellent safety record. Because available evidence supports the safety of Rotarix®, no medical follow-up is needed for patients who have been vaccinated with Rotarix®.
This temporary suspension will enable further evaluation of the vaccine by the FDA and CDC while not losing its efficacy.
Vaccine Storage and Handling:
- Isolate the Rotarix® vaccine while maintaining the proper cold chain in anticipation of the cancellation of the suspension.
- Do not return or discard the vaccine.
It is important to note:
- The vaccine is effective.
- Children who completed the 2 dose series are considered protected.
- There is no need to re-administer any Rotarix® doses.
- If the Rotarix® vaccine series has not been completed, complete the series with 2 doses of RotaTeq® at the appropriate intervals.
- There is no need to test children who received the vaccine.
The FDA press release is available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm. The FDA has established a website with information regarding the rotavirus vaccine at www.fda.gov/NewsEvents/PublicHealthFocus/ucm205585.htm#hcpFDA. This website will provide updates as more information becomes available from the FDA.
The Bureau will send out any updates as they become available.
Updated Vaccine Information Statements
September 26, 2008 -- The Bureau of Immunization would like to remind our partners of the importance of using the current Vaccine Information Statements (VIS). By Federal law, all vaccine providers must give patients, or their parents or legal representatives, the appropriate VIS whenever a vaccination is given.
During the month of September, minor updates were made to several VISs. Changes could include correcting the web addresses of VAERS or the Vaccine Injury Compensation Program on some of the older VISs, adding the new statement about the availability of translations, cleaning up fonts that don't print properly, etc. None of these changes affect the mandated purpose of VISs (i.e., to inform parents or patients about the benefits and risks of vaccines). Edition dates on these VISs have not changed, and it is not necessary to replace existing stocks. Affected VISs are anthrax, DTaP, hepatitis A, hepatitis B, Hib, HPV, Japanese encephalitis, pneumococcal conjugate, pneumococcal polysaccharide, polio, rabies, rotavirus, shingles, Tdap, typhoid, and yellow fever.
Rotavirus VIS Update
A new interim rotavirus VIS available that replaces the interim VIS dated 4/12/06. The interim VIS, dated 8/28/08, includes information about the ROTARIX® (GSK) vaccine schedule. Providers may use up stocks of the 4/12/06 interim VIS for patients receiving RotaTeq® (Merck) vaccine; patients receiving ROTARIX® should receive the 8/28/08 interim VIS.
Multi-vaccine VIS Update
An updated interim edition of the pediatric multi-vaccine VIS has been posted. Providers using the multi-vaccine VIS when administering Rotarix® should begin using the new edition now. When Rotarix® is not administered, the older edition may be used until stocks are used up.
- Multi-Vaccine Interim VIS
This VIS may be used in place of individual VISs whenever routine birth through 6-month of age vaccines are administered at the same visit. The vaccines included are diptheria-tetanus-pertusiss (DTaP), inactivated polio vaccine (IPV), Haemophilus influenzae type b (Hib), hepatitis B (Hep B), pneumococcal conjugate vaccine (PCV), and Rotavirus and also include the combination vaccines (e.g., Pediarix® Comvax®, Pentacel®) containing those components. When using this VIS, please check the boxes on the first page indicating which antigens are being administered.
Note that this VIS is four pages, front and back, instead of the usual two pages, front and back. Use of the Multi-vaccine VIS is optional. The individual VISs for these vaccines may still be used.
VIS links in the Florida SHOTS program always point to the current versions of all vaccine information statements.
For the latest information concerning VIS updates, frequently visit the CDC's VIS web site. Many Vaccine Information Statements are available in Spanish and other languages. As new editions are translated, they are posted on the Immunization Action Coalition's website. As needed, providers should supplement VISs orally, with videotapes, with additional printed material, or in any other way that will help recipients understand the disease and vaccine.
Food and Drug Administration Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
April 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 2-dose series to infants from 6 to 24 weeks of age. (FDA Press Release)
Rotateq® Label Change
The 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/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm142393.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.
CDC Reaffirms Vaccine Policy Recommendations to Routinely Vaccinate U.S. Infants With Rotavirus Vaccine
The 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.
RotaTeq® (Rotavirus Vaccine) and Intussusception Information
The 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. (http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm100895.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.
Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices
At the request of the Centers for Disease Control and Prevention (CDC), the Bureau of Immunization is pleased to announce the release of the Morbidity and Mortality Weekly Report (MMWR) 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/preview/mmwrhtml/rr5512a1.htm ?s_cid=rr5512a1_e.
A final VIS will be available after the new VIS is developed according to legally-mandated procedures.
