August 3, 2011 -- On July 8, 2011, the Food and Drug Administration (FDA) approved a label change for the Merck vaccine, RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent).
The new label reflects changes to the current package insert that includes a contraindication for "history of intussusception" and a corresponding revision to update the section "Who should not receive RotaTeq."
These recommendations have already been incorporated in the Vaccine Information Statements which you have been providing to caregivers of vaccine recipients.
December 17, 2010 -- The Bureau of Immunization wishes to announce the availability of an updated (interim) rotavirus Vaccine Information Statement (VIS) posted on December 7, 2010. This updated VIS includes information about a possible increased risk of intussusception among vaccine recipients and revised wording on porcine circovirus, along with several minor changes.
VIS are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VIS be handed out when (before each dose) certain vaccinations are given.
Print-ready files can be found on the CDC website at www.cdc.gov/vaccines/pubs/vis/default.htm#rota.
These new VIS have been integrated into the Florida SHOTS™ (Florida State Health Online Tracking System), so registry users can access them electronically. Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If necessary, bureau staff can FAX copies to providers without internet access.
September 27, 2010 -- The Bureau of Immunization wishes to bring to your attention the following information concerning prescribing information and patient labeling for Rotarix® vaccine, manufactured by GlaxoSmithKline.
The Food and Drug Adminstration (FDA) has added information to the existing intussusception subsection of the Warnings and Precautions section of the Rotarix® vaccine label to inform healthcare providers about preliminary results from a postmarketing study conducted in Mexico. An interim analysis of this study suggests an increased risk of intussusception in the 31 day time period after the first dose of Rotarix® (relative risk of 1.8 with a 99% confidence interval of 1.0 to 3.1).
For the U.S., these findings translate to potentially 0-4 additional cases of intussusception hospitalizations per 100,000 infants within 31 days of receiving the first dose of Rotarix®. This takes into consideration the background rate of intussusception hospitalizations in the U.S., which is approximately 34 in 100,000 infants per year.
Further analysis showed that the increased number of intussusception cases occurred primarily within seven days after the first dose.
This information has also been included in the Postmarketing Experience subsection of the Adverse Reactions section of the prescribing information and in the information for the patient.
No changes have been made to the Contraindications or Indications for Use of Rotarix®.
- FDA: Approved Products - Rotarix®
- FDA: Information on Rotarix - Labeling Revision Pertaining to Intussusception, Questions and Answers
- The Centers for Disease Control and Prevention: Rotavirus
Rotavirus Vaccine is Now Contraindicated for Infants Diagnosed with Severe Combined Immunodeficiency
June 25, 2010 -- The Centers for Disease Control and Prevention (CDC) published Addition of Severe Combined Immunodeficiency as a Contraindication for Administration of Rotavirus Vaccine in the MMWR (June 11, 2010 / 59(22); 687-688). An excerpt is reprinted below.
In response to reported cases of vaccine-acquired rotavirus infection in infants with severe combined immunodeficiency (SCID) following rotavirus vaccine administration, both Merck & Co. and GlaxoSmithKline Biologicals have revised the prescribing information and patient labeling for their respective rotavirus vaccine products, pentavalent rotavirus vaccine (RV5) and monovalent rotavirus vaccine (RV1), with approval from the Food and Drug Administration. Merck revised the prescribing information and patient labeling for RV5 in December 2009, and GlaxoSmithKline Biologicals did so for RV1 in February 2010. After the revision to the RV5 prescribing information, the CDC sought consultation from members of the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP). On the basis of that consultation and available data, CDC is updating the list of contraindications for rotavirus vaccine. Rotavirus vaccine (both RV5 and RV1) is contraindicated in infants diagnosed with SCID. Consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before rotavirus vaccine is administered. General guidelines on immunodeficiency and use of live virus vaccines are available in the 2009 Red Book, Table 1.14.
To access the full article, go to: www.cdc.gov/mmwr/preview/mmwrhtml/mm5922a3.htm
May 17, 2010 -- The Bureau of Immunization is pleased to bring to your attention this important updated information concerning licensed vaccines against rotavirus, released by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
On May 14, 2010, the FDA revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and healthcare professionals to resume the use of Rotarix® and to continue the use of RotaTeq®.
The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA's own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA's Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.
The FDA also considered the following in its decision:
- Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
- The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
- The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the U.S. These benefits outweigh the risk, which is theoretical.
Information for parents and caregivers is available on the FDA website at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm
Information for healthcare providers is available on the FDA website at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm
The CDC 's website has links regarding vaccines against rotavirus: http://www.cdc.gov/vaccines/vpd-vac/rotavirus/default.htm#FDA
The CDC has posted a revised Rotavirus Vaccine Information Statement (VIS) at: http://www.cdc.gov/vaccines/pubs/vis/default.htm#rota
Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If necessary, bureau staff can FAX copies to providers without internet access.
Prevention of Rotavirus Gastroenteritis Among Infants and Children, Recommendations of the Advisory Committee on Immunization Practices (ACIP)
February 6, 2009 -- The Centers for Disease Control and Prevention has released Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices (ACIP) in MMWR Recommendations and Reports, February 6, 2009 / 58(RR02);1-25. The Bureau of Immunization is pleased to draw your attention to this document, the summary of which is presented in its entirety below.
Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Before initiation of the rotavirus vaccination program in the United States in 2006, approximately 80% of U.S. children had rotavirus gastroenteritis by 5 years of age. Each year during the 1990s and early 2000s, rotavirus resulted in approximately 410,000 physician visits, 205,000-272,000 emergency department visits, and 55,000-70,000 hospitalizations among U.S. infants and children, with total annual direct and indirect costs of approximately $1 billion. In February 2006, a live, oral, human-bovine reassortant rotavirus vaccine (RotaTeq® [RV5]) was licensed as a 3-dose series for use among U.S. infants for the prevention of rotavirus gastroenteritis, and the Advisory Committee on Immunization Practices (ACIP) recommended routine use of RV5 among U.S. infants (CDC. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-12]). In April 2008, a live, oral, human attenuated rotavirus vaccine (Rotarix® [RV1]) was licensed as a 2-dose series for use among U.S. infants, and in June 2008, the ACIP updated its rotavirus vaccine recommendations to include use of RV1. This report updates and replaces the 2006 ACIP statement for prevention of rotavirus gastroenteritis. The ACIP recommends routine vaccination of U.S. infants with rotavirus vaccine. RV5 and RV1 differ in composition and schedule of administration. RV5 is to be administered orally in a 3-dose series, with doses administered at 2, 4, and 6 months of age. RV1 is to be administered orally in a 2-dose series, with doses administered at 2 and 4 months of age. The ACIP does not express a preference for either RV5 or RV1. The recommendations in this report also address the maximum ages for doses, contraindications, precautions, and special situations for the administration of rotavirus vaccine.
The document is available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm?s_cid=rr5802a1_e.
Delayed Onset and Diminished Magnitude of Rotavirus Activity: United States, November 2007 through May 2008
June 27, 2008 -- The Florida Department of Health, Bureau of Immunization announces publication of the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report (MMWR); June 25, 2008, Vol. 57, Early Release; Delayed Onset and Diminished Magnitude of Rotavirus Activity: United States, November 2007 through May 2008.
In the United States, rotavirus causes few deaths, but results in approximately 55,000 to 70,000 hospitalizations and 205,000 to 272,000 emergency department visits each year. In February 2006, a rotavirus vaccine was recommended for routine use among infants in the United States. The CDC analyzed rotavirus activity through May 3 of the current 2007-08 season. The results indicated that, compared with seasons spanning 1991 through 2006, rotavirus activity during the current season appeared delayed in onset by 2 to 4 months and diminished in magnitude by greater than 50%.
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)
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