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Thread: ACIP Issues Guidelines for Use of Influenza A (H1N1) 2009 Monovalent Vaccine

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    Arrow ACIP Issues Guidelines for Use of Influenza A (H1N1) 2009 Monovalent Vaccine

    August 27, 2009 The US Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has issued guidelines regarding the use of vaccine against infection with novel influenza A (H1N1) virus. The new recommendations were posted online August 21 in the Morbidity and Mortality Weekly Report.

    "Because novel influenza A (H1N1) virus is continuing to cause illness in the United States and worldwide, the primary focus of vaccination efforts should be to vaccinate as many persons as possible in the recommended target groups as quickly as possible once vaccine becomes available," write Anne Schuchat, MD, and colleagues from the National Center for Immunization and Respiratory Diseases, CDC.

    H1N1 Vaccine Use

    "As vaccine availability increases, additional groups are recommended for vaccination.... These recommendations are intended to provide vaccination programs and providers with information to assist in planning and to alert providers and the public about target groups comprising an estimated 159 million persons who are recommended to be first to receive influenza A (H1N1) 2009 monovalent vaccine," write Dr. Schuchat and colleagues.

    To assess which population groups should first be targeted for vaccination, the ACIP reviewed epidemiologic and clinical data on July 29, 2009. The ACIP also evaluated the projected supply likely to be available when the vaccine first becomes available, as well as the anticipated increase in vaccine availability during the following 6 months. By mid-October 2009, it is anticipated that licensed H1N1 vaccine will be available.

    The guidelines recommend that vaccination efforts begin as soon as the vaccine is available. In accordance with state and local conditions, state and local health officials and vaccination providers should make decisions concerning vaccine administration and distribution.

    Vaccination and healthcare providers should be vigilant about following announcements and other information forthcoming from state and local health departments and the CDC regarding vaccination against H1N1 virus infection. The CDC's influenza Web site and state and local health departments may provide additional information.

    ACIP H1N1 Vaccine Recommendations

    Key points of the ACIP recommendations include the following 3 items.

    * First, 5 general population groups that should be targeted as an initial focus of vaccination efforts are pregnant women, household contacts or caregivers for infants younger than 6 months (such as parents, siblings, and daycare providers), healthcare and emergency medical services personnel, children and young adults 6 months to 24 years of age, and persons aged 25 to 64 years who are at greater risk for influenza-related complications because of underlying medical conditions. These medical conditions increasing risk for influenza-related complications include chronic pulmonary conditions, including asthma; cardiovascular conditions except for hypertension; renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic disorders, including diabetes mellitus; and immunosuppression caused by medications or by human immunodeficiency virus.
    * Second, if initial vaccine availability is insufficient to meet demand, priority is established for a subset of persons within the initial target groups. These persons who are to receive priority for vaccination (order of target groups does not indicate priority) include pregnant women, household contacts or caregivers for infants younger than 6 months, healthcare and emergency medical services personnel in direct contact with patients or infectious material, children 6 months to 4 years of age, and children and adolescents aged 5 to 18 years who are at greater risk for influenza-related complications because of underlying medical conditions.
    * Third, as vaccine availability increases, other adult population groups should receive H1N1 vaccine in accordance with the guidelines recommendations.

    In addition, ACIP made additional recommendations concerning the use of influenza A (H1N1) 2009 monovalent vaccine, as follows:

    * The number of doses of vaccine needed for immunization against H1N1 has not been determined. Vaccine should not be stockpiled for patients who already have received 1 dose but might require a second dose, because vaccine availability is expected to increase over time.
    * If different anatomic sites are used, inactivated vaccines against seasonal and H1N1 viruses may be administered simultaneously. However, ACIP does not recommend simultaneous administration of live, attenuated vaccines against seasonal and H1N1 virus.
    * All persons, including those older than 65 years of age, who are currently recommended for seasonal influenza vaccine should receive the seasonal vaccine as soon as it is available. Recommendations for use of the 2009 to 2010 seasonal influenza vaccine were previously published.

    "The guiding principle of these recommendations is to vaccinate as many persons as possible as quickly as possible," the guidelines authors state."ACIP will review new epidemiologic and clinical data as they become available and might revise these recommendations."

    Morb Mortal Wkly Rep. Published online August 21, 2009.

    Clinical Context

    On June 11, 2009, the World Health Organization declared a worldwide pandemic of the H1N1 virus. The signs and symptoms of H1N1 virus infection are similar to those of the seasonal influenza, and specific testing is required to distinguish H1N1 virus from seasonal influenza virus. Definitive diagnosis requires testing for the H1N1 viruses with real-time reverse transcriptase-polymerase chain reaction or viral culture. Unlike the seasonal influenza, few severe cases of the H1N1 virus infection have occurred among older persons; the highest hospitalization rates for illness caused by this virus have been among persons younger than 65 years.

    Because transmission will most likely persist during the upcoming fall and winter seasons, this report provides recommendations by the ACIP regarding the use of vaccine against infection with H1N1 virus. The licensed vaccine is expected to be available by mid-October 2009.
    Study Highlights

    * The recommendations are intended to provide vaccination programs and providers with information to reach the target groups comprising an estimated 159 million persons who are recommended to be first to receive H1N1 2009 monovalent vaccine.
    * The guiding principle of these recommendations is to vaccinate as many persons as possible as quickly as possible when the vaccine is made available.
    * Highlights of these recommendations include (1) the identification of 5 initial target groups for vaccination efforts, (2) establishment of priority for a subset of persons within the initial target groups in the event that initial vaccine availability is unable to meet demand, and (3) guidance on use of vaccine in other adult population groups as vaccine availability increases.
    * When the vaccine is first available, the ACIP recommends vaccination of the following 5 target groups:
    o Pregnant women
    o Persons who live with or provide care for infants younger than 6 months (eg, parents, siblings, and daycare providers)

    o Healthcare and emergency medical services personnel
    o Persons aged 6 months to 24 years
    o Persons aged 25 to 64 years who have medical conditions that put them at higher risk for influenza for influenza-related complications
    * If the supply of the vaccine is not adequate to meet the demand for vaccination among the 5 target groups, the ACIP recommends that the following subset of the initial target groups receive priority for vaccination until the vaccine availability increases:
    o Pregnant women
    o Persons who live with or provide care for infants younger than 6 months (eg, parents, siblings, and daycare providers)
    o Healthcare and emergency medical services personnel who have direct contact with patients or infectious material
    o Children aged 6 months to 4 years
    o Children and adolescents aged 5 to 18 years who have medical conditions that put them at higher risk for influenza-related complications
    * Once vaccination programs and providers are meeting the demand for vaccine among the persons in the 5 initial target groups, vaccination should be expanded to all persons aged 25 to 64 years.
    * Because studies demonstrate that the risk for infection among persons older than 65 years is less vs persons in younger age groups, expanding vaccination recommendation to include adults older than 65 years is recommended once demand for vaccine among younger age groups has been met.
    * Additional information regarding the use of H1N1 2009 monovalent vaccine include the following:
    o The number of doses of vaccine required for immunization against novel H1N1 has not been established.
    o Simultaneous administration of inactivated vaccine against seasonal and novel H1N1 viruses is permissible if different anatomic sites are used; however, simultaneous administration of live, attenuated vaccines is not recommended.
    o All persons currently recommended for seasonal influenza vaccine should receive the seasonal vaccine as soon as it is available.
    * Vaccination and healthcare providers should be alert to announcements and additional information from state and local health departments and the CDC concerning vaccination against novel H1N1 virus infection.

    Clinical Implications

    * Once the H1N1 vaccine is made available, the ACIP recommends vaccination of the following 5 target groups: pregnant women, persons who live with or provide care for infants younger than 6 months, healthcare and emergency medical services personnel, persons aged 6 months to 24 years, and persons aged 25 to 64 years who have medical conditions that put them at higher risk for influenza or influenza-related complications.
    * If the H1N1 vaccine has limited availability, the ACIP recommends the following subset of the initial target groups receive priority for vaccination: pregnant women, persons who live with or provide care for infants younger than 6 months, healthcare and emergency medical services personnel who have direct contact with patients or infectious material, children aged 6 months to 4 years, and children and adolescents aged 5 to 18 years who have medical conditions that put them at higher risk for influenza-related complications.




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    September 22, 2009 — An Expert Panel of the Infectious Diseases Society of America (IDSA) has prepared updated, evidence-based guidelines for immunization of infants, children, adolescents, and adults. The new guidelines, which are published in the September 15 issue of Clinical Infectious Diseases, replace the previous IDSA clinical practice guideline for quality standards for immunization, published in 2002.

    "The IDSA updates its guidelines when new data or publications change prior recommendations or when the Expert Panel decides that clarification or additional guidance is warranted," write Larry K. Pickering, from the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues. "For the 2009 guidelines, vaccine licensure, approval, recommendations, safety, financing, barriers, and implementation issues were reviewed. This report does not include issues involving vaccines and autism and other potential adverse events."

    These guidelines are intended to assist clinicians who care for either immunocompetent or immunocompromised people of all ages to provide recommended vaccinations. Since the previous clinical practice guideline was published in 2002, there have been significant improvements in the ability to prevent more infectious diseases.

    New Vaccines, Recommendations

    New vaccines that have been licensed since 2002 include human papillomavirus vaccine; live, attenuated influenza vaccine; meningococcal conjugate vaccine; rotavirus vaccine; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine; and zoster vaccine. New combination vaccines that have become available are measles, mumps, rubella, and varicella vaccine; tetanus, diphtheria, and pertussis and inactivated polio vaccine; and tetanus, diphtheria, and pertussis and inactivated polio/Haemophilus influenzae type b vaccine.

    For young children, hepatitis A vaccines are now universally recommended. All children aged 6 months through 18 years and adults who are 50 years or older should receive annual administration of influenza vaccines. The routine childhood and adolescent immunization schedule now includes a second dose of varicella vaccine. The adolescent and adult immunization schedules have expanded to accommodate many of these new recommendations.

    Other areas highlighted in the updated guidelines include the need to remove barriers to immunization, to eliminate racial and ethnic disparities in access to and compliance with vaccine recommendation, to address issues regarding vaccine safety, and to fund the cost of implementing recommended vaccinations.

    The updated guidelines also provide specific recommendations for vaccination of special groups, including healthcare providers, immunocompromised patients, pregnant women, international travelers, and internationally adopted children. If the 46 standards featured in these guidelines are followed, it is hoped that vaccination in multiple population groups should facilitate optimal disease prevention while maintaining high levels of safety.

    Specific vaccine recommendations for infants, children, adolescents, and adults, and their accompanying level of evidence rating, are as follows:

    Infants, children, adolescents, and adults should be given all age-appropriate vaccines as recommended by the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American Academy of Pediatrics (level of evidence, A-1).

    When a vaccine dose is not given at the recommended age, it should be given at any subsequent medical visit when indicated and feasible, without restarting the series (level of evidence, A-3).

    For people who have delayed immunizations or who want to accelerate their vaccination schedule, recommendations for the minimum interval between doses should still be followed (level of evidence, B-3).

    All indicated vaccines should be administered simultaneously when appropriate and feasible (level of evidence, B-3).

    Licensed combination vaccines may be given provided the following conditions apply:

    Any components of the combination are indicated, other components are not contraindicated, and the US Food and Drug Administration (FDA) has licensed the vaccine for that dose of the series (level of evidence, A-1).

    For childcare, schools and colleges, and nursing homes, specific immunization requirements should be followed (level of evidence, A-2).

    Vaccinations delivery should be coordinated with other preventive healthcare services recommended for children, adolescents, and adults (level of evidence, B-3).

    Storage and administration of all vaccines should follow recommendations of the manufacturer and licensing requirements from the FDA (level of evidence, B-2).

    Performance measures and goals recommended in the updated guidelines are as follows:

    Reduce incidence of vaccine-preventable diseases, as monitored through postlicensure surveillance, in accordance with Healthy People 2010 and 2020 goals.

    Implement new vaccines recommended for routine use by the Advisory Committee on Immunization Practices within 6 months of a published recommendation, and reach coverage levels of at least 90% within 5 years of a published recommendation.

    Monitor immunization coverage for vaccines recommended for routine use in the general population in each of the 50 states and among people of different racial or ethnic backgrounds.

    Regularly measure the immunization rates of patients in each clinical practice.

    Implement quality standards in each complementary setting offering immunizations.

    Enter data regarding immunizations into state or community population-based immunization information systems. Immunizations administered in complementary settings should be included.


    The IDSA supported formulation of these guidelines. Some of the guidelines authors report various financial relationships with Merck, GlaxoSmithKline, Sanofi Pasteur, the Advisory Committee on Immunization Practices working group for Influenza and HPV, Astellas, MedImmune, Wyeth, AstraZeneca, the National Institute of Health, the Centers for Disease Control and Prevention, Novavax, Protein Sciences, Novartis, CSL Limited, PowderMed, and/or Avianax.

    Clin Infect Dis. 2009;49:817–840. Abstract

    Additional Resource

    More information on immunizations and vaccinations is available on the Centers for Disease and Control Prevention Web site.




    Clinical Context

    In the September 2002 issue of Clinical Infectious Diseases, the IDSA published guidelines for the immunization of persons from infancy to adulthood. Since then, changes in the vaccine schedule include new vaccines, new combination vaccines, expansion of vaccines, and increased focus on immunization barriers, ethnic disparities, vaccine safety, finances, and specific populations.

    The IDSA Standards and Practice Guidelines Committee convened an Expert Panel, which reviewed data published since 2000, expert opinion, and the recommendations of the American Academy of Family Physicians, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, Advisory Committee on Immunization Practices, American College of Physicians, National Vaccine Advisory Committee, Task Force on Community Preventive Services, and National Vaccine Injury Compensation Program.

    These 2009 guidelines update the 2002 ISDA guidelines and provide recommendations to ensure appropriate immunizations of children and adults, including current standards, barriers, vaccine safety, misconceptions, finance, access, strategies, and special populations. The guidelines received clearance by the Centers for Disease Control and Prevention, support from the American Medical Association, and endorsement from the American Academy of Pediatrics, the National Association of Pediatric Nurse Practitioners, and the Pediatric Infectious Diseases Society.


    Study Highlights

    All age-appropriate vaccines should be received per the American Academy of Family Physicians, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, Advisory Committee on Immunization Practices, and American College of Physicians guidelines, which are issued annually and updated in the Morbidity and Mortality Weekly Report.

    Vaccines not given at recommended age should be given at a subsequent visit without restarting the vaccine series.

    The minimum interval between doses should be used for persons with delayed immunizations or who want an accelerated schedule.

    All indicated appropriate vaccines should be given simultaneously.

    Licensed combination vaccines can be given if indicated, if licensed by the FDA, and if no components are contraindicated.

    Immunization requirements for childcare, school, and nursing homes should be followed.

    Vaccines should be given with other preventive healthcare services.

    Vaccines should be stored and administered per manufacturer and FDA protocols.

    Healthcare providers need to adhere to vaccine contraindications and precautions.

    Vaccine Information Statements for patients and parents are required for each vaccine covered by the National Childhood Vaccine Injury Act.

    Vaccine benefits, safety, and risk information should be provided in a culturally appropriate and easily understandable manner.

    Significant adverse events should be reported to the Vaccine Adverse Event Reporting System.

    Financial recommendations include minimizing patient out-of-pocket expenses and using vaccine-financing programs.

    Barriers to immunizations should be minimized.

    Immunizations should be easily accessible via express services and expanded hours.

    Strategies to improve vaccine coverage are reminder systems; registries; standing orders in clinics, hospitals, and nursing homes; vaccine review at each visit; provision of vaccine records to patients; provider education; assessment of vaccine rates in practices; and awareness of adolescent and adult vaccines.

    Complementary immunization settings, including schools, shopping malls, and pharmacies, are recommended.

    Complementary immunization providers should follow quality standards, provide records to primary care providers and registries, and encourage visits to primary care providers for preventive and therapeutic services.

    All healthcare professionals should receive appropriate immunizations, including tetanus, diphtheria, and pertussis booster dose; measles; mumps; rubella; varicella; hepatitis B; and annual influenza vaccine.

    Hospitals, clinics, and offices should ensure that healthcare professionals receive appropriate immunizations and perform annual assessment.

    Immunocompromised patients might have increased risk for morbidity and mortality from infections, consequences from immunizations, or inadequate response to immunizations.
    Household contacts of immunocompromised persons should receive appropriate immunizations.

    For pregnant women, providers should be aware of routinely recommended vaccines, contraindications, and precautions.

    After delivery, women should receive any recommended vaccine that could not be given during pregnancy.

    For persons who travel, vaccine considerations include immunization and medical history, itinerary, season, travel living conditions, travel mode and purpose, amount of time before departure, and whether vaccines are required or recommended.

    For internationally adopted children without written documentation of vaccines, the alternatives are antibody titers or reimmunization.


    Clinical Implications


    Age-appropriate vaccinations should be administered as recommended. Measures to improve access include vaccine-financing programs, reminder systems, vaccine registries, standing orders for vaccines, review of vaccine status at each visit, patient possession of vaccine records, provider education, assessment of vaccine rates, awareness of adolescent and adult vaccines, and complementary immunization settings.
    Populations that require special consideration of vaccine status include healthcare providers, immunocompromised persons, pregnant women, international travelers, and internationally adopted children.

    Source:

    Code:
    http://cme.medscape.com/viewarticle/709284?src=cmenews&uac=92391AT

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