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Immunization Action Coalition
IAC Express 2009
Issue number 819: August 24, 2009
Please click here to subscribe to IAC Express as well as other FREE IAC periodicals.
Contents of this Issue
Select a title to jump to the article.
  1. CDC publishes ACIP recommendations for use of influenza A (H1N1) 2009 monovalent vaccine
  2. FDA licenses new Hib vaccine, Hiberix
  3. It's time to start vaccinating people against seasonal influenza!
  4. CDC releases guidance for businesses and institutions of higher education related to influenza prevention
  5. JAMA publishes articles on HPV vaccine
  6. IAC redesigns its Immunization Topics section
  7. IAC's Video of the Week reports on preventing neonatal tetanus in Cote d'Ivoire
  8. "CDC Features" includes information for parents and patients about meningitis and pertussis
  9. IAC's padded screening questionnaires for contraindications now have English on front, Spanish on the back--a popular translation at no added cost!
  10. August 21 MMWR includes previously published article about oseltamivir-resistant H1N1 virus infection in two immunosuppressed patients
  11. MMWR publishes correction to table in the ACIP seasonal influenza recommendations
  12. VIS translations: VISs for influenza (TIV) and Td/Tdap vaccines now available in Turkish
  13. National Committee for Quality Assurance offers a free online continuing education program
  14. World Rabies Day Symposium scheduled for September 28 in Atlanta
  15. Influenza Congress to be held November 18-20 in Washington, DC
  16. Massachusetts Immunization Action Partnership's 14th annual conference set for October 15
 
Abbreviations
AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; AMA, American Medical Association; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD, National Center for Immunization and Respiratory Diseases; NIVS, National Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
  
Issue 819: August 24, 2009
1.  CDC publishes ACIP recommendations for use of influenza A (H1N1) 2009 monovalent vaccine

CDC published "Use of Influenza A (H1N1) 2009 Monovalent Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009" in an August 21 MMWR Early Release. The summary follows in its entirety.


This report provides recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of vaccine against infection with novel influenza A (H1N1) virus. Information on vaccination for seasonal influenza has been published previously (CDC. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices [ACIP], 2009. MMWR 2009;58[No. RR-8]). Vaccines against novel influenza A (H1N1) virus infection have not yet been licensed; however, licensed vaccine is expected to be available by mid-October 2009. On July 29, 2009, ACIP reviewed epidemiologic and clinical data to determine which population groups should be targeted initially for vaccination. ACIP also considered the projected vaccine supply likely to be available when vaccine is first available and the expected increase in vaccine availability during the following 6 months. 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. The guiding principle of these recommendations is to vaccinate as many persons as possible as quickly as possible. Vaccination efforts should begin as soon as vaccine is available. State and local health officials and vaccination providers should make decisions about vaccine administration and distribution in accordance with state and local conditions. Highlights of these recommendations include (1) the identification of five initial target groups for vaccination efforts (pregnant women, persons who live with or provide care for infants aged <6 months, healthcare and emergency medical services personnel, children and young adults aged 6 months-24 years, and persons aged 25-64 years who have medical conditions that put them at higher risk for influenza-related complications), (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. Vaccination and healthcare providers should be alert to announcements and additional information from state and local health departments and CDC concerning vaccination against novel influenza A (H1N1) virus infection. Additional information is available from state and local health departments and from CDC's influenza website (http://www.cdc.gov/flu).


To access the complete recommendations in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/pdf/rr/rr58e0821.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP recommendations), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html

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2 FDA licenses new Hib vaccine, Hiberix

On August 19, FDA issued a press release announcing that it had approved a new Hib vaccine, Hiberix. Hiberix is licensed for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b (Hib) when administered as a booster dose in children 15 months through 4 years of age (prior to fifth birthday).

The press release is reprinted below in its entirety.


ACCELERATED APPROVAL OF HIBERIX TO HELP SUSTAIN ADEQUATE VACCINE SUPPLY

Vaccine Approved as a Hib Booster Dose

The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, NC, and Philadelphia.

A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, NJ).

This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from Dec. 18, 2007, through June 25, 2009.

Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.

"The FDA approved Hiberix under the agency's accelerated approval pathway," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research. "This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations."

Before the availability of Hib vaccines, Hib disease was the leading cause of bacterial meningitis among children under 5 years old in the United States. Meningitis is an infection of the tissue covering the brain and spinal cord, which can lead to lasting brain damage and deafness. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones, and tissue covering of the heart, as well as death. Hib disease is spread through the air by coughing and sneezing.

In 1992, the FDA disseminated rules regarding accelerated approval. The rules allow for earlier approval of treatments that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (including products that provide prophylaxis to those who would not otherwise be treated during a shortage). The use of such an approach can shorten the time required for product testing prior to receiving FDA approval. Accelerated approval is granted on the condition that clinical trials are continued during the post-approval marketing of the product to verify the anticipated clinical benefit.

Hiberix is used in nearly 100 countries. The FDA based its conclusion that Hiberix is safe and effective for use as a booster dose in certain children in the United States on data from seven clinical studies conducted in Europe, Latin America, and Canada that involved more than 1,000 children.

As part of the approval, the manufacturer, GlaxoSmithKline, will conduct a post-market study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the United States. The study is intended to confirm the clinical benefit of booster immunization with Hiberix in accordance with the accelerated approval regulations, and to provide additional data on Hiberix for young infants.

The most common side effects seen in the studies following a booster dose of Hiberix included pain and redness at the injection site, fever, fussiness, loss of appetite, and restlessness.

FDA's Recall Notice on PedvaxHIB and COMVAX:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm053289.htm

U.S. Centers for Disease Control and Prevention's "Hib Vaccine--Q&A for Providers about the Return to the Hib 'Booster' Dose":
http://www.cdc.gov/vaccines/vpd-vac/hib/faqs-return-to-booster-hcp.htm

FDA's website on fast-track, accelerated approval and priority review:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

Federal Register, Dec. 11, 1992, Final Rule, Preamble, New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval:
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3627b2bm.pdf


To access the press release online, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179533.htm

To access the vaccine package insert, go to:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM179530.pdf

To access the approval letter, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179531.htm

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3 It's time to start vaccinating people against seasonal influenza!

Many healthcare professionals have been asking if it's too soon to start vaccinating patients against seasonal influenza. The answer is no--CDC advises to begin administering seasonal influenza vaccine as soon as vaccine becomes available.

Vaccinating now with seasonal influenza vaccine will allow more time for healthcare providers to focus on later immunization efforts when vaccine for 2009 H1N1 influenza A virus becomes available. You will be vaccinating against both seasonal influenza and 2009 H1N1 throughout the fall and winter, so it's best to get a head start on your efforts starting now.

In addition, early vaccination of children younger than age 9 years who are first time vaccinees (or who failed to get their second dose in the preceding season) can be helpful in assuring routine second doses before the influenza season begins.

Finally, it's always a good rule of thumb to take advantage of an opportunity to vaccinate instead of relying on patients to come back for another appointment.

Many resources regarding influenza disease and vaccination are available to healthcare professionals and the public. Following is a list of some of them.

To access the National Influenza Vaccine Summit website, go to:
http://www.preventinfluenza.org

To access IAC's Seasonal Influenza web section, go to:
http://www.immunize.org/influenza

To access IAC's H1N1 Influenza web section, go to:
http://www.immunize.org/h1n1

To access CDC's Seasonal Flu web section, go to:
http://www.cdc.gov/flu

To access CDC's Novel H1N1 Flu web section, go to:
http://www.cdc.gov/h1n1flu

To access IAC's print pieces related to influenza, including screening questionnaires, patient education pieces, and sample standing orders, go to:
http://www.immunize.org/printmaterials/dis_inf.asp

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4 CDC releases guidance for businesses and institutions of higher education related to influenza prevention

CDC recently posted new or updated information to various sub-sections of its H1N1 Flu web section. Following are the titles and URLs of documents that have been posted since the August 17 issue of IAC Express:

CDC Guidance for Businesses and Employers To Plan and Respond to the 2009-2010 Influenza Season
http://www.cdc.gov/h1n1flu/business/guidance

Preparing for the Flu: A Communication Toolkit for Businesses and Employers
http://www.cdc.gov/h1n1flu/business/toolkit

CDC Guidance for Responses to Influenza for Institutions of Higher Education during the 2009-2010 Academic Year
http://www.cdc.gov/h1n1flu/institutions/guidance

Technical Report on CDC Guidance for Responses to Influenza for Institutions of Higher Education during the 2009-2010 Academic Year
http://www.cdc.gov/H1N1flu/institutions/guidance/technical.htm

Preparing for the Flu: A Communication Toolkit for Institutions of Higher Education
http://www.cdc.gov/h1n1flu/institutions/toolkit

FOR MORE INFORMATION
The home page of CDC's H1N1 Flu web section can be accessed from
http://www.cdc.gov/h1n1flu

IAC has gathered information related to H1N1 influenza into a single web section at
http://www.immunize.org/h1n1

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5 JAMA publishes articles on HPV vaccine

On August 19, the Journal of the American Medical Association (JAMA) published an article co-authored by CDC and FDA that summarizes reports to the Vaccine Adverse Event Reporting System (VAERS) related to HPV vaccine administered from June 1, 2006, through December 31, 2008. This is the first published postlicensure study that includes clinical review of medical records associated with reports to VAERS.

To access the abstract for "Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine," go to:
http://jama.ama-assn.org/cgi/content/short/302/7/750?home

To read a FDA summary about HPV vaccine safety that includes information from the new study, go to:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

The JAMA issue also includes an editorial that discusses the risks and benefits of HPV vaccination and a special communication that critiques the marketing of HPV vaccine. Links to both are given below:

To access the full text of the editorial, "The Risks and Benefits of HPV Vaccination," go to:
http://jama.ama-assn.org/cgi/content/full/302/7/795?home

To access the abstract for the special communication, "Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism," go to:
http://jama.ama-assn.org/cgi/content/short/302/7/781?home

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6 IAC redesigns its Immunization Topics section

On August 19, IAC announced the completion of another phase of its website redesign. The Immunization Topics section has been completely redesigned and can be accessed at http://www.immunize.org/iztopics

The topics covered in this section include international adoption, dialysis, vaccination rate disparities, vaccination of healthcare personnel, the hepatitis B birth dose, vaccination in long-term care, vaccine mandates and exemptions, vaccination for men who have sex with men, needle safety, pregnancy, immunization registries, tattoos and body piercing, and travel. Each page includes links to a wide variety of relevant resources.

Be sure to check out this updated resource at
http://www.immunize.org/iztopics

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7 IAC's Video of the Week reports on preventing neonatal tetanus in Cote d'Ivoire

IAC encourages IAC Express readers to watch a 2.5-minute video on preventing neonatal tetanus in Cote D'Ivoire. Tetanus is responsible for 7 percent of neonatal deaths worldwide. The bacterium thrives in dirt and rust and can be contracted by newborns through unsanitary conditions during childbirth. To address this issue, the government of Cote d'Ivoire, with the support of UNICEF and other international partners, is offering free tetanus vaccinations to more than 5 million women.

The video will be available on the home page of IAC's website through August 30. To access it, go to: http://www.immunize.org and click on the image under the words Video of the Week. It may take a few moments for the video to begin playing; please be patient!

Remember to bookmark IAC's home page to view a new video every Monday. To view an IAC Video of the Week from the past, go to the video archive at http://www.immunize.org/votw/jul09.asp

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8 "CDC Features" includes information for parents and patients about meningitis and pertussis

The "CDC Features" web section includes new articles about meningitis and pertussis targeted toward parents and patients.

To access "Pertussis (Whooping Cough)--What You Need To Know," go to:
http://www.cdc.gov/Features/Pertussis

To access "Have You Heard About How To Prevent Meningococcal Disease?" go to http://www.cdc.gov/Features/CDCtv/Meningitis

To access an alphabetical index of all "CDC Features," go to:
http://www.cdc.gov/az

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9 IAC's padded screening questionnaires for contraindications now have English on front, Spanish on the back--a popular translation at no added cost!

In response to demand, IAC now has a Spanish-language translation of the questions on its padded Screening Questionnaire for Child and Teen Immunization and Screening Questionnaire for Adult Immunization. Printed on the back of the English page, the Spanish page has been added to this product at no additional cost.

The questionnaires give you and your patients a quick, easy, and thorough way to determine if they have contraindications and precautions to vaccination. Patients fill out the questionnaire with yes-or-no answers while waiting to be seen, allowing you to review their responses quickly and be confident you're not missing any contraindications or precautions.

The questionnaires come in convenient tear-off pads of 100 sheets. The price per pad is economical (discounts for two pads or more), so you'll be able to keep pads at the receptionist's desk, the nurse's station, and in every exam room. Each pad comes with four English-language reference sheets (printed on heavy-weight paper) for health professionals.

Prices start at $16 each for one pad and drop to $12 each for two, $11 each for three, and $10 each for four. For quotes on larger quantities or customizing, call (651) 647-9009 or email admininfo@immunize.org

To learn more about the padded screening questionnaires, or to order online or download an order form, visit

Screening Questionnaire for Child and Teen Immunization
http://www.immunize.org/shop/pad_sqchild.asp

Screening Questionnaire for Adult Immunization
http://www.immunize.org/shop/pad_sqadult.asp

IAC's offers other products for sale, including educational videos and personal immunization record cards, at
http://www.immunize.org/shop

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10.  August 21 MMWR includes previously published article about oseltamivir-resistant H1N1 virus infection in two immunosuppressed patients

CDC published "Oseltamivir-Resistant Novel Influenza A (H1N1) Virus Infection in Two Immunosuppressed Patients--Seattle, Washington, 2009" in the August 21 MMWR. This report was previously released as an MMWR Dispatch on August 14, and was previously covered in IAC Express on August 17.

To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5832a3.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5832.pdf

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11.  MMWR publishes correction to table in the ACIP seasonal influenza recommendations

CDC published "Errata: Vol. 58, No. RR-8" in the August 21 MMWR. This article corrects information in Table 2 (page 13) of ACIP's "Prevention and Control of Seasonal Influenza with Vaccines," released on July 31.

To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5832a4.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5832.pdf

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12.  VIS translations: VISs for influenza (TIV) and Td/Tdap vaccines now available in Turkish

The current versions of the VISs for seasonal injectable influenza vaccine (dated 8/11/09) and for Td/Tdap vaccine (dated 11/18/08) are now available on the IAC website in Turkish. IAC gratefully acknowledges Mustafa Kozanoglu, MD, and Murat Serbest, MD, for the translations.

To obtain the VIS for seasonal injectable influenza vaccine (TIV) in Turkish, go to:
http://www.immunize.org/vis/tu_flu06.pdf

To obtain the VIS for seasonal injectable influenza vaccine (TIV) in English, go to:
http://www.immunize.org/vis/2flu.pdf

To obtain the VIS for Td/Tdap vaccine in Turkish, go to:
http://www.immunize.org/vis/tu_td94.pdf

To obtain the VIS for Td/Tdap vaccine in English, go to:
http://www.immunize.org/vis/td_tdap.pdf

For information about the use of VISs, and for VISs in more than 35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis

For general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis

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13.  National Committee for Quality Assurance offers a free online continuing education program

The National Committee for Quality Assurance is offering a free online continuing education program titled "Best Practices in Childhood and Adolescent Immunization." The program is intended for physicians, nurses, and pharmacists. For more information, go to:
http://www.ncqa.org/tabid/82/default.aspx

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14.  World Rabies Day Symposium scheduled for September 28 in Atlanta

The CDC World Rabies Day Symposium is scheduled for September 28 in Atlanta at the CDC Global Communications Center. The program will focus on the importance of rabies prevention and control at the global and national levels, as well as human and animal rabies epidemiology, diagnosis, and surveillance issues.

For more information, go to:
http://www.cdc.gov/rabies/events/WRD09.html

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15.  Influenza Congress to be held November 18-20 in Washington, DC

"Influenza Congress USA" will bring together global pharmaceutical companies, biotechs, government representatives, academicians, and investors to discuss influenza policy and planning and research and development. For more information, go to: http://www.terrapinn.com/2009/usaflu/index.stm

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16.  Massachusetts Immunization Action Partnership's 14th annual conference set for October 15

The 14th annual Massachusetts Immunization Action Partnership conference is scheduled for October 15 in Marlborough, MA. The keynote speaker will be Dr. Ari Brown, pediatrician and co-author of "Baby 411: Clear Answers and Smart Advice for Your Baby's First Year" and "Toddler 411: Clear Answers & Smart Advice for Your Toddler."

For more information, go to:
http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/miap_brochure.pdf

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Immunization Action Coalition  •  1573 Selby Ave  •  St. Paul, MN 55104
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.