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  • Status of Licensure and Recommendations for New VaccinesNew

  • Breaking News—Red Book Online Special Alerts (including archives)

    Special Alert: CDC Reinstates Hib Booster Dose Due to Improving Supply Posted 6/25/09
    Due to an improving supply of Haemophilus influenzae type b (Hib) vaccine, the Centers for Disease Control and Prevention (CDC), in consultation with the American Academy of Pediatrics and the American Academy of Family Physicians, reinstated the booster dose of Hib vaccine for all children 12 through 15 months of age on June 25th. Recommendations for reinstatement of Hib booster dose

    • Infants should receive their primary Hib series at ages 2, 4 and 6 months, and a Hib booster dose on time at 12 through 15 months of age.
    • Older children for whom a Hib booster dose was deferred should receive the Hib booster at the next routinely scheduled visit or medical encounter.
    • Mass recall of children for their catch-up Hib booster dose is not recommended at this time because physicians may encounter supply problems during such a massive recall.
    "Updated Recommendations for Use of Haemophilus influenzae Type b (Hib) Vaccine: Reinstatement of the Booster Dose at Ages 12-15 Months," MMWR, June 26.

    Although Merck has not yet returned to market with its Hib-containing vaccines, sanofi pasteur has increased production of monovalent Hib vaccine, PRP-T (ActHIB), and DTaP-IPV/Hib (Pentacel). Enough Hib-containing vaccine is now available for distribution to allow a return to the full dose schedule for all children 12 through 15 months of age and for children 15 through 60 months who come in for routine health services and who did not receive their booster dose. Providers should expect some additional doses of Hib vaccine each month. However, supplies are not yet adequate to support a mass recall of children whose booster dose was delayed.

    For more information, see the article in the July 2009 issue of AAP News, in addition to the Morbidity and Mortality Weekly Report (MMWR) dispatch. The MMWR dispatch includes additional recommendations to ensure that eligible patients receive all currently recommended doses of this important immunization.

    AAP News - July 2009 Issue | CDC MMWR
    Go to Red Book text:
    Section 3, Haemophilus influenzae Infections

    Special Alert: New 2009 Edition of Red Book now on Red Book Online Posted 6/18/09
    The newly revised and updated Red Book: 2009 Report of the Committee on Infectious Diseases, 28th Edition is now available on Red Book Online. Included in this edition are new and updated sections, chapters, and appendices, updated references to AAP policy recommendations, standardized vaccine abbreviations, and much more. In addition, over 200 new images were added to the Visual Library.

    Search the latest findings and clinical guidelines for diagnosis, treatment, and prevention of pediatric infectious diseases.

    View a list of the changes in the Summary of Major Changes or the Red Book Spotlight Section on the Red Book Online home page.

    Special Alert: AAP Update on H1N1 Influenza Posted 5/12/09
    As many states now have the ability to test and confirm cases of novel H1N1 infection, the ongoing count of confirmed cases has rapidly increased as expected, with 3009 cases reported from 44 states as of May 12 at 11 a.m. ET. In the U.S., 3 deaths have been reported in patients with confirmed infection. All tested strains remain susceptible to oseltamivir (Tamiflu) and zanamivir (Relenza).

    AAP has updated its resources on Novel H1N1 influenza (swine influenza) for health care professionals and for parents/caretakers.

    The following links have been added:
    • Interim Guidance for Public Gatherings in Response to Human Infections with Novel Influenza A (H1N1) from the CDC - updated May 10th
    • AAP has developed answers to frequently asked questions for parents/caretakers to provide up-to-date information on key issues and concerns. These can be downloaded and used in the office - updated May 11th
    Latest information about Novel H1N1 influenza and links to the CDC update site, are posted daily on the Academy's Web pages: H1N1 Flu (Swine Flu) Information for Health Care Professionals and H1N1 Flu (Swine Flu) Information for Parents and Caregivers

    CDC Information | Red Book Online Influenza Resource Page
    Go to Red Book text:
    Section 3, Influenza

    Special Alert: Regular AAP H1N1 Flu (Swine Flu) Updates Posted 5/1/09
    Stay updated on the H1N1 flu (swine flu) outbreak with the following resources:

    H1N1 Flu (Swine Flu) Information for Health Care Professionals from the American Academy of Pediatrics (AAP)
    H1N1 Flu (Swine Flu) Information for Parents and Caregivers from the American Academy of Pediatrics (AAP)

    Excerpt on outbreaks, epidemics, and other infectious disease emergencies and hand hygiene from the AAP publication “Managing Infectious Diseases in Child Care and Schools: A Quick Reference Guide, 2nd Edition” (Copyright © 2009 American Academy of Pediatrics)

    CDC Information | Red Book Online Influenza Resource Page
    Go to Red Book text:
    Section 3, Influenza

    Special Alert: 40 H1N1 Flu (Swine Flu) Cases Confirmed in the U.S. Posted 4/27/09
    The U.S. has declared a public health emergency after 40 cases of swine influenza are confirmed in California, Kansas, New York, Ohio and Texas, and in other countries. The virus, for which there is no known vaccine, is described as a strain of influenza A (H1N1) not previously found in pigs or humans. The American Academy of Pediatrics is closely monitoring communications from the Centers for Disease Control and Prevention and the World Health Organization.

    Click on the following links to read an excerpt on outbreaks, epidemics, and other infectious disease emergencies and hand hygiene from the AAP publication “Managing Infectious Diseases in Child Care and Schools: A Quick Reference Guide, 2nd Edition” (Copyright © 2009 American Academy of Pediatrics).

    Click here for the latest information about swine flu, including prevention tips for patients, information for schools and day care centers, and links to the CDC update site.

    CDC Information | Red Book Online Influenza Resource Page
    Go to Red Book text:
    Section 3, Influenza

    Special Alert: Swine Influenza, 7 Human Cases Identified Posted 4/24/09
    As of Thursday, April 23, 2009, the Centers for Disease Control and Prevention (CDC) had confirmed seven human cases of swine influenza A (H1N1) virus infection. Five of these cases were identified in San Diego County and Imperial County, California and two cases in San Antonio, Texas. The CDC is working with local and state health agencies to investigate these cases.

    While it has not been determined how easily the virus spreads between people, the CDC has determined that it is contagious and spreading and recommends that people in these areas take precautionary measures.

    CDC Information | Red Book Online Influenza Resource Page
    Go to Red Book text:
    Section 3, Influenza

    Special Alert: New Hib Cases, 2 Deaths Posted 3/19/09
    The Philadelphia Department of Public Health has announced that five cases of Haemophilus influenzae type b (Hib) invasive disease occurred in children in Pennsylvania since October 2008, resulting in two deaths. All of these cases were in unvaccinated or under-vaccinated children. One of the children, an unvaccinated 4-year-old child whose family belongs to a religious community that eschews medical care, died of bacterial meningitis due to Hib in March 2009.

    These cases, along with the five cases of invasive Hib disease reported in Minnesota in 2008, are a reminder of the severity of Hib disease and the risk to children who are unimmunized or partially immunized. The resurgence of invasive Hib disease has occurred during a nationwide Hib vaccine shortage that began in December 2007 and may have resulted from an increase in Hib carriage with transmission to non-protected children. Therefore, it is critically important that children receive the primary three-dose Hib vaccine series on schedule during this shortage. Minimum recommended intervals between doses of the Hib vaccine primary series should be used to bring children who are behind schedule up to date. Until the vaccine shortage is resolved, the booster dose normally given at 12 through 15 months of age should be deferred except for high-risk children. High-risk children should receive the 12 through 15 month dose on schedule.

    The Centers for Disease Control and Prevention (CDC) published a Health Advisory on March 18 which provides additional information on meeting the challenge of providing the 3-dose primary series during the Hib vaccine shortage.

    AAP News addressed the Hib vaccine shortage, recent cases and catch-up recommendations in the March issue.

    The AAP issued an alert on the Minnesota cases of Hib in January.

    AAP News - March Issue | CDC Health Advisory
    Go to Red Book text:
    Section 3, Haemophilus influenzae Infections

    Special Alert: Shortage of Acyclovir Posted 3/2/09
    Manufacturers of acyclovir for injection have experienced a recent increase in demand, resulting in a national shortage of parenteral acyclovir. The AAP Committee on Infectious Diseases recommends that existing supplies of intravenous acyclovir be conserved to improve availability for neonatal herpes simplex virus (HSV) infections, herpes simplex encephalitis (HSE), and HSV and varicella-zoster virus (VZV) infections in immunocompromised patients, including more ill pregnant women with visceral dissemination of either virus. When parenteral acyclovir is not available, intravenous ganciclovir should be substituted.

    Alternative regimens to intravenous acyclovir and alternatives for non-priority conditions are outlined in an exclusive Red Book Online Intravenous Acyclovir Shortage Table at http://aapredbook.org/news/acyclovir.dtl.

    The March issue of AAP News addresses the acyclovir shortage.

    Red Book Online Intravenous Acyclovir Shortage Table | AAP News
    Go to Red Book text:
    Section 3, Herpes Simplex
    Section 3, Varicella-Zoster Infections

    Special Alert: Updated Guidelines for Rotavirus Vaccine Use Posted 3/2/09
    Two rotavirus vaccine products are now licensed for use in infants in the United States: RV1 (Rotarix), which was approved in 2008, and RV5 (RotaTeq), which was approved in 2006. The two vaccines differ in composition and dosing schedule. The AAP Committee on Infectious Diseases has revised its rotavirus recommendations to guide pediatricians in administering these vaccines.

    See the statement and the article in the March issue of AAP News.

    AAP News
    Go to Red Book text:
    Section 3, Rotavirus Infections

    Special Alert: Hib Alert: 5 Cases, 1 Death Posted 3/2/09
    The U.S. Centers for Disease Control and Prevention (CDC) announced that five cases of invasive Haemophilus influenzae, type b (Hib) disease were confirmed in 2008 in Minnesota. This is the highest number of cases of this vaccine-preventable disease in children under 5 years of age that Minnesota has seen since 1991.

    Three patients had meningitis, one had pneumonia, and one had epiglottitis. Three of the children received no vaccinations due to parent or guardian deferral or refusal. One of the unimmunized patients, a 7-month-old infant, died of Hib meningitis. The two remaining children received age-appropriate immunizations. One child, a 5-month-old, had received two Hib immunizations. A 5-month-old had received two Hib immunizations but was not old enough to have completed the primary series. The other child was 15 months old and was fully vaccinated for age, but subsequent to Hib infection, was diagnosed with an immune deficiency (hypogammaglobulinemia).

    A Morbidity and Mortality Weekly Report (MMWR) dispatch is available. Information for parents and providers is also available. The MMWR dispatch covers recommendations for ensuring that all eligible patients receive all currently recommended doses of this important immunization as well as guidance for those infants who have chronic conditions that qualify them for the booster dose.

    The March issue of AAP News addresses the importance that all children receive their primary three-dose series of Hib-containing vaccine during the shortage. The December issue of AAP News addresses the Hib vaccine shortage.

    CDC Links: MMWR | Hib Alert | Information for Parents and Providers
    AAP News - March Issue | AAP News - December Issue
    Go to Red Book text:
    Section 3, Haemophilus influenzae Infections

    Special Alert: Time to Order Influenza Vaccine for 2009-2010 Season Posted 3/2/09
    It is time to order influenza vaccine for the 2009-2010 season. When ordering next season's supply of vaccine, the AAP reminds pediatricians that the current recommendation is to immunize all children aged 6 months through 18 years. Pediatricians should consider partnering with schools and community clinics to fulfill the increased need for flu vaccination. See the article in the March issue of AAP News.

    AAP News
    Go to Red Book text:
    Section 3, Influenza

    Special Alert: AAP Posts Statement on Autism Ruling Posted 2/12/09
    The American Academy of Pediatrics (AAP) posted a statement on February 12, 2009 acknowledging that autism is a serious condition that has profound effects on a child and the child's family. Further research is needed to better understand the cause of autism spectrum disorders and the most effective treatments. Meanwhile, the AAP is supporting its pediatricians with knowledge about autism screening and current approaches to therapy, through resources such as the Autism Toolkit.

    The U.S. Court of Federal Claims today found the scientific evidence is "overwhelmingly contrary" to the theory that MMR vaccine and thimerosal in vaccines is linked to autism. This decision is in keeping with the numerous medical studies that have been performed worldwide. The AAP hopes the determination by the Special Masters will reassure parents that vaccines do not cause autism.

    The full reports of the Special Masters are available on the U.S. Court of Federal Claims Web site.

    Additional information on this statement is available at the AAP Member Center.

    Parent resources:
    The Childhood Immunization Schedule: Why is it Like That?
    Questions and Answers About Vaccine Ingredients
    Immunization information

    Special Alert: Data Show HPV4 Vaccine Safe Posted 1/26/09
    Data demonstrating the safety of the quadrivalent human papillomavirus vaccine (HPV4) recently were presented to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).

    A little over two years after licensure of HPV4 and with more than 20 million doses distributed in the United States, no safety issues have been detected through the Vaccine Adverse Event Reporting System (VAERS), a post-licensure study being performed within the CDC’s Vaccine Safety Datalink (VSD) project and a Clinical Immunization Safety Assessment Network (CISA) study of rare neurologic events. However, media reports and misinterpretation of the adverse events submitted to VAERS have caused some parents to become concerned.

    Based on an analysis of the current safety and efficacy data, the Academy continues to recommend HPV4 vaccine for all 11- to 12-year-old girls and catch-up immunization of all girls and women 13 through 26 years of age.

    Go To Source

    Special Alert: Hepatitis A Vaccine Now Available Posted 1/26/09
    According to the CDC, Merck & Co had previously experienced production delays that resulted in temporarily not accepting orders for Pediatric and Adult hepatitis A vaccines (Pediatric & Adult VAQTA®). As of December 1, 2008, Merck's Pediatric/Adolescent formulation of hepatitis A vaccine, VAQTA®, is available for ordering. Based on current information, it is estimated that the Adult formulation of VAQTA® will be available in second quarter 2009. GSK production and supply of their Pediatric and Adult hepatitis A vaccine (Pediatric & Adult Havrix®) and their Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) are currently in good supply to meet demand.

    Go To Source

    Special Alert: Interim Antiviral Therapy Recommendations for Oseltamivir Resistance to H1N1 Influenza A Strains Posted 12/29/08
    Early Centers for Disease Control and Prevention (CDC) influenza surveillance data, which indicate growing resistance to oseltamivir (Tamiflu®) by circulating H1N1 influenza A strains isolated so far this year, have led the CDC to issue interim recommendations for the use of antiviral therapy.

    The oseltamivir resistant H1N1 strains remain susceptible to zanamivir (Relenza®), an antiviral medicine which can only be used in children 7 years of age and older, and to amantadine/rimantadine.

    All H3N2 influenza A strains and influenza B strains analyzed to date are susceptible to both oseltamivir and zanamivir.

    More details and interim treatment guidance are provided by the CDC.

    Pediatric doses of all influenza antivirals are available in the AAP Policy Statement.

    Fortunately, the influenza strains examined to date appear well-matched for this year’s influenza vaccine. This highlights the critically important value in giving influenza vaccine to all children 6 months through 18 years of age and to everyone who lives with, provides care for, or comes in contact with children.

    Special Alert: Hib Shortage Update Posted 12/29/08
    In December 2007, Merck announced a recall of Hib vaccine and temporarily stopped selling the vaccine in the U.S. market as they changed manufacturing processes. In response to the decrease in vaccine supply, the Centers for Disease Control and Prevention (CDC) and the AAP provided interim recommendations for Hib vaccination. These were to continue the three dose primary series of Hib vaccine but defer the booster dose given at 12 to 15 months because it was unlikely that there would be adequate supplies of vaccine to fully vaccinate all children with four doses of the Hib vaccine. At that time, Merck anticipated returning their vaccine to the market in late 2008.

    Now Merck states that they will not return to the Hib vaccine market until mid-2009. At this time, the CDC and the AAP are not changing the interim Hib vaccine recommendations, but will closely monitor the Hib vaccine supply situation and will make appropriate recommendations if the need arises. More information is available through the CDC Web site.

    Go to Red Book text:
    Section 3, Haemophilus influenzae Infections

    Special Alert: Recommendations for Influenza Vaccine, 2008-2009 Posted 12/29/08
    The American Academy of Pediatrics (AAP) expanded its recommendations of annual influenza immunization to include all children, both healthy and with high-risk conditions, 6 months through 18 years of age. The recommendations of annual influenza immunization also include household contacts and out-of-home care providers of children with high-risk conditions and healthy children younger than 5 years; any female who will be pregnant during influenza season; and, health care professionals.

    The purpose of this policy statement is to update the recommendations for routine use of influenza vaccine in children. To view this policy statement in its entirety, please click here.

    Go to Red Book text:
    Section 1, Sources of Vaccine Information

    Special Alert: Pediatric Luminary Dies at Age 70 Posted 10/3/08
    A man known for his broad-reaching contributions to the field of infectious diseases and remembered by colleagues and those he mentored for his warmth, caring and compassion, Ralph D. Feigin, M.D., FAAP, of Houston, died Aug. 14 of lung cancer at age 70. Dr. Feigin was a lifetime nonsmoker.

    Dr. Feigin was looking forward to assuming the role of editor of Pediatrics on Jan. 1. He served as the journal’s associate editor for 14 years (1994-’08). He also was author or co-author of 15 books, including six editions of the Textbook of Pediatric Infectious Diseases, was co-editor of Oski’s Pediatrics: Principles and Practice and editor of UpToDate in Pediatrics, among other scholarly publications. He published more than 500 articles. His research uncovered a better understanding of diseases such as bacterial meningitis, leptospirosis, osteomyelitis, septic arthritis and measles.

    Go To SourceSpecial Alert: HPV Vaccine: AAP Update Posted 7/23/08
    Rumors have begun to circulate about the safety of Gardasil® human papillomavirus (HPV) vaccine based on a news story about adverse events being reported. Most adverse events following administration of a vaccine are mild and self limited and include pain and redness at the injection site.

    Based on the risk/benefit profile of HPV vaccine, the American Academy of Pediatrics continues to recommend routine HPV vaccination for 11-12 year old girls and catch up vaccination for 13-18 year old girls. As with any vaccine, continuous monitoring for and review of adverse events that occur after HPV vaccine administration, with follow-up as necessary, will assure that our HPV vaccine program is as safe as possible. This monitoring includes physician and parent reports to the VAERS system.

    Centers for Disease Control and Prevention and Food and Drug Administration are conducting an ongoing study of VAERS reports describing adverse events following Gardasil.

    The CDC-FDA information on Gardasil safety is now posted on the Immunization Safety and FDA CBER Web sites.

    Additional information for providers and parents about HPV, HPV vaccine and a summary of Gardasil reports to VAERS can be found at the following websites:

    CDC: HPV Vaccination page
    CDC: HPV vaccine safety Q and A’s for the public.
    CDC: HPV vaccine Q and A for public
    Summary of Gardasil reports to VAERS

    Go to HPV in Red Book Online.

    Special Alert: Measles outbreaks in the United States: Public health preparedness, control and response in healthcare settings and the community Posted 4/16/08
    The CDC issued a Health Advisory on April 2, 2008 regarding a measles outbreak in Arizona that was linked to an importation from Switzerland. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia. Through March 31, 2008, nine confirmed cases were reported to the Arizona Department of Health Services.

    For the entire health advisory, please click on the CDC link below.

    CDC Link
    Go to Red Book text:
    Section 3, Measles

    Special Alert: Hib Booster Doses Suspended Due to Shortage of Hib Vaccines Posted 12/20/07
    The recent suspension of production by Merck & Co., Inc. of PedvaxHIB® and COMVAX® and Merck's subsequent voluntary recall of certain lots of both vaccines on December 13th have led to a significant disruption in the supply of Haemophilus influenzae type b (Hib) containing vaccines. The Centers for Disease Control and Prevention (CDC) is making some Hib vaccine available from its stockpile and sanofi pasteur is increasing production of its licensed Hib vaccine, ActHIB®, to attempt to meet the current demand for Hib vaccine in the United States. However, a significant temporary shortage of Hib containing vaccines is now expected. AAP has been working with the CDC and other stakeholders to develop an interim strategy to best meet the needs of children during the shortage. A CDC Dispatch published today in Morbidity and Mortality Weekly Report provides additional details on the expected shortage and interim recommendations.

    In brief, recommendations include:
    1. Temporary deferral of the routine Hib vaccine booster dose administered at 12-15 months of age except for children who are at increased risk for invasive Hib disease, as described below. A register and tracking system should be developed to facilitate recalling these children when vaccine supply improves.
    2. Children at increased risk for invasive Hib disease should continue to receive the recommended booster dose of Hib vaccine at 12-15 months of age. Children at increased risk include: American Indian and Alaskan Native children (AI/AN), and children with sickle cell disease, HIV infection, anatomic or functional asplenia, malignancies or other immunocompromising conditions. Any Hib containing vaccine licensed for use at 12-15 months of age (PedvaxHIB®, ActHIB® or TriHIBit®) can be administered. TriHIBit® is only licensed to be administered at the 12-15 month of age visit.
    3. The primary series for all children should be completed on schedule with 2 doses of a PRP-OMP containing Hib conjugate vaccine (PedvaxHIB® or COMVAX®) given at 2 and 4 months of age or 3 doses of a PRP-T containing conjugate vaccine (ActHIB®) given at 2, 4 and 6 months of age.
    4. Hib vaccines are considered interchangeable for primary immunization. Therefore, either vaccine can be used to complete the primary series. However, if only one of the two first doses given at 2 and 4 months of age was a PRP-OMP containing vaccine, a total of three doses of Hib containing vaccine is needed to complete the primary series.
    5. Physicians who serve predominantly AI/AN populations should attempt to give a PRP-OMP containing vaccine as the first dose because of the high risk of invasive Hib disease at an early age in this population and the more rapid protective antibody response seen with PRP-OMP. The CDC will prioritize distribution of remaining stocks of PRP-OMP containing vaccines for use in AI/AN children living in predominantly AI/AN communities.
    6. The appropriate number and timing of doses of Hib vaccine for children who are behind schedule is available in the 2006 Red Book (pages 28-32) and online at Red Book Online.
    7. All isolates of H. influenzae from sterile sites should be serotyped and cases promptly reported to your state health department.
    8. To allow maximum distribution of available Hib vaccine, physicians should order only the number of doses of vaccine required to meet their needs for the next 4 weeks.

    CDC Link
    Go to Red Book text:
    Section 3, Haemophilus influenzae Infections

    Special Alert: CDC Updates Recommendations for Treatment of Gonococcal Infections Posted 4/25/07
    The Centers for Disease Control and Prevention (CDC) has updated its sexually transmitted diseases treatment guidelines and "no longer recommends the use of fluoroquinolones for the treatment of gonococcal infections and associated conditions such as pelvic inflammatory disease (PID)." Click here for the full MMWR article.

    CDC Link
    Go to Red Book text:
    Section 3, Gonococcal Infections
    Section 3, Pelvic Inflammatory Disease

    Special Alert: AAP Recommends Universal Immunization for Hepatitis A Posted 4/11/07
    In a new 2007 policy statement, the American Academy of Pediatrics has recommended that all children should receive hepatitis A vaccine at 1 year of age (12–23 months) as a 2-dose regimen. The 2-dose series should be administered at least 6 months apart.

    AAP Policy Statement (PDF) | Red Book Online Vaccine Status Table
    Go to Red Book text:
    Section 3, Hepatitis A

    Special Alert: Two Doses of Varicella Vaccine Now Recommended By AAP Posted 4/11/07
    In a new 2007 policy statement, the American Academy of Pediatrics has published its recommendation of a 2-dose varicella immunization strategy. Children 12 months through 12 years of age should receive two 0.5 ml doses of varicella vaccine, separated by at least 3 months. Children 13 years of age or older without evidence of immunity, should receive two 0.5 ml doses of varicella vaccine separated by at least 28 days.

    AAP Policy Statement (PDF) | Red Book Online Vaccine Status Table
    Go to Red Book text:
    Section 3, Varicella-Zoster Infections

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