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Immunization Action Coalition
IAC Express 2009
Issue number 805: June 15, 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 releases new interim H1N1 influenza guidelines, including one about use of PPSV vaccine
  2. WHO raises H1N1 influenza pandemic alert to Phase 6
  3. IAC's Video of the Week features HHS Secretary Sebelius discussing the U.S. response to the WHO pandemic declaration
  4. Dr. Thomas Frieden becomes 16th director of CDC
  5. FDA revises the label for Gardasil to include additional information on syncope
  6. CDC releases guidance about protecting infants against hepatitis B when using Pentacel during the Hib vaccine shortage
  7. IAC adds three letters to its Press Room web section
  8. VISs can now be downloaded to mobile devices
  9. Check out "Factcines," a helpful book for vaccine-hesitant parents
  10. New journal articles of interest
  11. CDC to sponsor net conference on H1N1 and seasonal influenza on July 16
  12. Immunize Georgia conference scheduled for September 11
 
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 805: June 15, 2009
1.  CDC releases new interim H1N1 influenza guidelines, including one about use of PPSV vaccine

CDC's web page titled H1N1 Flu Clinical and Public Health Guidance has recently been updated with more interim guidance documents, including one promoting current recommendations for the use of PPSV vaccine. Information on the guidance document on the use of PPSV vaccine follows immediately. Links to other recently posted guidance documents are given at the end of this IAC Express article.

CDC is urging healthcare professionals to vaccinate all individuals for whom PPSV vaccine is recommended to protect them from pneumococcal disease during this H1N1 influenza outbreak. Of special concern are the persons with high-risk conditions for whom PPSV vaccine is recommended, but to whom the vaccine is rarely given. For example, in the 2007 National Health Interview Survey, only 16% of at-risk adults ages 18-49 years had received a dose of PPSV vaccine.

Following are three paragraphs from the document "Interim guidance for use of 23-valent pneumococcal polysaccharide vaccine during novel influenza A (H1N1) outbreak," excluding a link to a table.


. . . CDC's Advisory Committee on Immunization Practices (ACIP) recommends a single dose of PPSV23 for all people 65 years and older and for persons 2 to 64 years of age with certain high-risk conditions. People in these groups are at increased risk of pneumococcal disease as well as serious complications from influenza. A single revaccination at least five years after initial vaccination is recommended for people 65 years and older who were first vaccinated before age 65 years as well as for people at highest risk, such as those who have no spleen, and those who have HIV infection, AIDS, or malignancy.

All people who have existing indications for PPSV23 should continue to be vaccinated according to current ACIP recommendations during the outbreak of novel influenza A (H1N1). Emphasis should be placed on vaccinating people aged less than 65 years who have established high-risk conditions because PPSV23 coverage among this group is low and because people in this group appear to be overrepresented among severe cases of novel influenza A (H1N1) infection, based on currently available data. PPSV23 coverage estimates are available at:
http://www.cdc.gov/flu/professionals/vaccination/pdf/NHIS89_07ppvvaxtrendtab.pdf

Use of PPSV23 among people without current indications for vaccination is not recommended at this time. This recommendation may be revised as the epidemiology and clinical presentation of novel influenza A (H1N1) virus infection as well as the frequency and severity of secondary pneumococcal infections are better understood . . .


To read the entire document, including background about pneumococcal disease and PPSV and PCV vaccines, go to:
http://www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm

OTHER NEWLY RELEASED OR UPDATED GUIDANCE DOCUMENTS

Interim Guidance on Case Definitions to be Used For Investigations of Novel Influenza A (H1N1) Cases
http://www.cdc.gov/h1n1flu/casedef.htm

Interim Guidance-HIV-Infected Adults and Adolescents: Considerations for Clinicians Regarding Novel Influenza A (H1N1) Virus
http://www.cdc.gov/h1n1flu/guidance_HIV.htm

Interim Novel Influenza A (H1N1) Guidance for Cruise Ships
http://www.cdc.gov/h1n1flu/guidance/cruiseships.htm

Interim Guidance for Airlines Regarding Flight Crews Arriving from Domestic and International Areas Affected by Swine Influenza
http://www.cdc.gov/h1n1flu/guidance/air-crew-dom-intl.htm

CDC has also posted interim guidance on many other topics. To access the web page, which is constantly evolving, go to:
http://www.cdc.gov/H1N1flu/guidance

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

IAC has gathered important information related to H1N1 influenza in a new web section to make it easier to keep up to date with developments. To access this resource, go to: http://www.immunize.org/h1n1

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2 WHO raises H1N1 influenza pandemic alert to Phase 6

On June 11, WHO raised the level of influenza pandemic alert from Phase 5 to Phase 6. The following explanation comes from CDC's H1N1 influenza website.


On June 11, 2009, the World Health Organization (WHO) raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the novel influenza A (H1N1) virus. A Phase 6 designation indicates that a global pandemic is underway.

More than 70 countries are now reporting cases of human infection with novel H1N1 flu. This number has been increasing over the past few weeks, but many of the cases reportedly had links to travel or were localized outbreaks without community spread. The WHO designation of a pandemic alert Phase 6 reflects the fact that there are now ongoing community level outbreaks in multiple parts of world.

WHO's decision to raise the pandemic alert level to Phase 6 is a reflection of the spread of the virus, not the severity of illness caused by the virus. It's uncertain at this time how serious or severe this novel H1N1 pandemic will be in terms of how many people infected will develop serious complications or die from novel H1N1 infection. Experience with this virus so far is limited and influenza is unpredictable. However, because novel H1N1 is a new virus, many people may have little or no immunity against it, and illness may be more severe and widespread as a result. In addition, currently there is no vaccine to protect against novel H1N1 virus.

In the United States, most people who have become ill with the newly declared pandemic virus have recovered without requiring medical treatment, however, CDC anticipates that there will be more cases, more hospitalizations and more deaths associated with this pandemic in the coming days and weeks. In addition, this virus could cause significant illness with associated hospitalizations and deaths in the fall and winter during the U.S. influenza season.


To read more about the current state of this pandemic, go to the following CDC web page:
http://www.cdc.gov/h1n1flu/update.htm

To read a transcript of the statement by Margaret Chan, Director-General of WHO, go to:
http://www.who.int/mediacentre/influenzaAH1N1_presstranscript_20090611.pdf

To access a document detailing the definitions for WHO pandemic phases, go to:
http://www.who.int/csr/disease/influenza/GIPA3AideMemoire.pdf

To read statements by HHS Secretary Kathleen Sebelius and DHS Secretary Janet Napolitano on the WHO decision to declare the novel H1N1 virus outbreak a pandemic, go to:
http://www.hhs.gov/news/press/2009pres/06/20090611a.html

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3 IAC's Video of the Week features HHS Secretary Sebelius discussing the U.S. response to the WHO pandemic declaration

On June 11th, WHO raised the level of influenza pandemic alert from Phase 5 to Phase 6. In IAC's Video of the Week, HHS Secretary Kathleen Sebelius discusses the U.S. response to the WHO pandemic declaration.

This 2-minute video will be available on the home page of IAC's website through June 21. To access it, go to: http://www.immunize.org and click on the image under the words Video of the Week, which you'll find toward the top of the page. 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. While you're at our home page, we encourage you to browse around--you're sure to find resources and information that will enhance your practice's immunization delivery.

All the videos featured as an IAC Video of the Week have recently been archived in a new section of IAC's website. To view any of the videos previously featured, go to: http://www.immunize.org/votw/may09.asp

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4 Dr. Thomas Frieden becomes 16th director of CDC

On June 8, Dr. Thomas Frieden began his role as CDC director. A related CDC press release follows in its entirety.


Thomas R. Frieden, MD, MPH, today became the 16th director of the Centers for Disease Control and Prevention (CDC) and administrator for the Agency for Toxic Substances and Disease Registry (ATSDR). He was named director of CDC by the White House and the Department of Health and Human Services on May 15.

Dr. Frieden, 48, has been the director of the New York City (NYC) Health Department since 2002. He is an infectious disease expert and has led initiatives that support wellness and prevention. He replaces Dr. Richard Besser who has been the acting CDC director and acting ATSDR administrator since mid January. Dr. Besser returns to his role as director of CDC's Coordinating Office for Terrorism Preparedness and Emergency Response.

In a May 15 White House press release, President Obama praised Dr. Frieden for his efforts in NYC and stated: "Dr. Frieden is an expert in preparedness and response to health emergencies, and has been at the forefront of the fight against heart disease, cancer, obesity, and infectious diseases such as tuberculosis and AIDS, and in the establishment of electronic health records. Dr. Frieden has been a leader for health care reform, and his experiences confronting public health challenges in our country and abroad will be essential in his new role."

"Dr. Frieden is widely regarded as one of the premier public health experts in the world and has a wealth of experience in public health and science," Health and Human Services Secretary Kathleen Sebelius said. "Dr. Frieden has a strong track record as a public health innovator and leader, which will serve CDC well as it continues to meet the nation's public health needs."

"I'm excited about the opportunity to lead CDC--the depth and breadth of knowledge at CDC is enormous," Dr. Frieden said. "President Obama and Secretary Sebelius recognize the importance of prevention--something CDC does well. Both are committed to prevention as a key component of health reform, as evidenced by the Recovery Act, and have highlighted the need for our society to do more to prevent, manage, and treat chronic diseases."

Dr. Frieden was a CDC Epidemic Intelligence Service Officer (EIS) from 1990 until 1992. He worked in NYC and investigated and fostered public awareness around tuberculosis, including strains of the bacteria with drug resistance. Along with then NYC Health Commissioner and current US Food and Drug Administration Commissioner Dr. Margaret Hamburg, Dr. Frieden led the effort that stopped the spread of drug-resistant tuberculosis in NYC in the mid 1990s. Following that, Dr. Frieden helped the Indian government establish a tuberculosis control program which has now saved more than one million lives. As NYC Health Commissioner, Dr. Frieden led efforts that reduced the number of smokers by 350,000 and cut teen smoking in half. NYC has also increased cancer screening, reduced AIDS deaths by 40%, improved collection and availability of information on community health, and implemented the nation's largest community electronic health records project. Dr. Frieden and this team have responded effectively to several urgent health problems, including cases of anthrax, plague, and, most recently novel H1N1 influenza.

Dr. Frieden earned his B.A. degree at Oberlin College in Ohio and his M.D. degree at Columbia University College of Physicians and Surgeons in New York. He earned his Masters of Public Health (MPH) at Columbia University's School of Public Health. He completed his internship and residency in internal medicine at Columbia-Presbyterian Medical Center and sub-specialty training in infectious diseases at Yale University. He is married with two children.

The CDC is the nation's disease prevention and wellness promotion agency, protecting people's health and safety, providing credible information to enhance health decisions, and improving health through strong partnerships. The agency includes 18 institutes, centers and offices, with approximately 14,000, full time, part time, and contract employees. CDC is headquartered in Atlanta and has experts located throughout the United States and in 54 countries. Its fiscal year 2009 budget is $6.7 billion with an additional $3.4 billion for the Vaccines for Children program.

A bio of Dr. Frieden is available at http://www.cdc.gov/about/leadership/leaders/Frieden.htm, and a high-resolution photo is available for download at http://www.cdc.gov/media/subtopic/images.htm

To read this press release online, go to:
http://www.cdc.gov/media/pressrel/2009/r090608.htm

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5 FDA revises the label for Gardasil to include additional information on syncope

On June 9, FDA's Center for Biologics Evaluation and Research revised the label for Gardasil HPV vaccine to include new information in the Warning and Precautions section noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.

Information on syncope has been in Gardasil's labeling for both providers and patients since 2007. However, FDA and CDC continue to receive reports of traumatic injuries in individuals who have fainted and fallen after receiving Gardasil. The addition of this information is intended to remind providers that Gardasil recipients should be observed closely for 15 minutes after vaccination.

Syncope has been reported after administration of other adolescent and adult vaccines, and is not unique to Gardasil or even to vaccination.

More complete information about this change can be found on FDA's website at
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm

CDC published information about syncope after vaccination in the May 2, 2008, MMWR. To read this article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5717a2.htm

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6 CDC releases guidance about protecting infants against hepatitis B when using Pentacel during the Hib vaccine shortage

CDC has posted a new document on its Current Vaccine Shortages and Delays web section to provide guidance about completing the hepatitis B vaccine series in settings where Pentacel (DTaP-IPV/Hib) is being used for the primary Hib series during the Hib vaccine shortage.

Providers using Pentacel vaccine to protect infants against Hib disease need to make every effort to have an adequate supply of monovalent hepatitis B vaccine available to ensure all infants receive timely hepatitis B vaccination and avoid excess doses of other antigens such as DTaP. This new document summarizes the best strategies for vaccination when using Pentacel, taking into account the infant's mother's hepatitis B surface antigen status and vaccine availability.

To access "Protecting Infants against Hepatitis B Virus Infection When Using Pentacel Vaccine during the Hib Vaccine Shortage," go to:
http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/eo-hib-hepb-cov.pdf

The home page of CDC's Current Vaccine Shortages and Delays web section can be accessed at
http://www.cdc.gov/vaccines/vac-gen/shortages

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7 IAC adds three letters to its Press Room web section

IAC recently added three letters related to current immunization issues to its Press Room web section. Descriptions of and links to the letters added to the Press Room page follow.

May 28, 2009
Letter to the Editor of the Star Tribune: IAC applauds the editorial that recognized the parallels between the parents of Danny Hauser and parents who fail to immunize their children against life-threatening diseases.
http://www.immunize.org/press/pr_startribune.asp

May 26, 2009
Letter to the Honorable Secretary Kathleen Sebelius: IAC encourages the Secretary to expand Medicare Part B benefits to cover all vaccines recommended for adults 65 years and older by the CDC's Advisory Committee on Immunization Practices
http://www.immunize.org/press/pr_sebelius.asp

May 22, 2009
Letter to the United States Senate Finance Committee: IAC calls for a reduction of cost-sharing for all vaccines recommended for older Americans by ACIP and the consolidation of all such vaccines under Medicare Part B
http://www.immunize.org/press/pr_senate1.asp

Other letters and information for the media can be accessed from IAC's Press Room at http://www.immunize.org/press

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8 VISs can now be downloaded to mobile devices

CDC has announced that patients and parents can now choose to download VISs onto a mobile device (e.g., iPhone, Palm Pre, BlackBerry) instead of taking a paper copy.

A new web page (http://www.cdc.gov/vaccines/pubs/vis/vis-downloads.htm) has been created to give patients easy access to the English-language VISs.

For more information, see the note on CDC's VIS News page at
http://www.cdc.gov/vaccines/pubs/vis/vis-news.htm

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

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9 Check out "Factcines," a helpful book for vaccine-hesitant parents

"Factcines" is a book written for parents by Susan Shoshana Weisberg, MD, FCP, FAAP, a board certified pediatrician with over 25 years of clinical experience. The book presents facts and data on vaccines, vaccine-preventable diseases, and possible vaccine side effects in a neutral manner.

The opening paragraph of the introduction reads, "There is no such thing as a risk free vaccine. There is no such thing as a complication free disease. And there is no such thing as a germ free life. So if you are reading this to find out if vaccines are safe, you are asking the wrong question. The issue is not simply whether a vaccine is safe or not, but rather if a vaccine is justified or not. And justifying immunizations is an equation that takes into account vaccine side effects, disease dangerousness, and exposure probability. The issue is not a one dimensional safety scale, but a more complex model of relative risk."

The book covers both general immunization issues such as the politics and economics of immunizations and vaccine schedules, and individual vaccines and the diseases they prevent.

To order a copy, go http://www.amazon.com and type in the name of the book. Dr. Weisberg donates all profits from the sale of this book to nonprofit charities that honor the memory and inspiration of Dr. Janusz Korczak, the pen name of Henryk Goldszmit, a beloved Polish pediatrician who died in a Nazi death camp in 1942.

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10.  New journal articles of interest

Several articles have recently been published in peer-reviewed journals that may be of interest to IAC Express readers.

Litigation related to vaccine safety

Litigation, Regulation, and Education--Protecting the Public's Health through Childhood Immunization
Author: Silverman RD
Source: N Engl J Med, June 11, 2009, Vol. 360(24):2500-01
http://content.nejm.org/cgi/content/extract/360/24/2500

When Vaccine Injury Claims Go to Court
Author: Stewart AM
Source: N Engl J Med, June 11, 2009, Vol. 360(24):2498-2500
http://content.nejm.org/cgi/content/extract/360/24/2498

Tdap

Response to an Education Program for Parents about Adult Pertussis Vaccination
Authors: Tam PY, Visintainer P, Fisher D
Source: Infect Control Hosp Epidemiol, June 2009, Vol. 30(6):589-92
http://www.ncbi.nlm.nih.gov/pubmed/19419326?dopt=AbstractPlus

Influenza

Worksite Policies Related to Influenza Vaccination: A Cross-Sectional Survey of U.S. Registered Nurses
Authors: Clark SJ, Cowan AE, Wortley PM
Source: Hum Vaccin, August 21, 2009, Vol. 5(8)
http://www.ncbi.nlm.nih.gov/pubmed/19458489?dopt=AbstractPlus

Adolescent Immunization

Increasing Adolescent Vaccination: Barriers and Strategies in the Context of Policy, Legal, and Financial Issues
Authors: Ford CA, English A, Davenport AF, Stinnett AJ
Source: J Adolesc Health, June 2009, Vol. 44(6):568-74
http://www.ncbi.nlm.nih.gov/pubmed/19465321?dopt=AbstractPlus

IAC offers links to thousands of immunization-related articles and abstracts at
http://www.immunize.org/journalarticles

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11.  CDC to sponsor net conference on H1N1 and seasonal influenza on July 16

CDC will be sponsoring a net conference titled "Novel Influenza A (H1N1) Update and Seasonal Influenza Recommendations for the 2009-2010 Season" on July 16 from noon-1:00 ET. The speaker will be Dr. Joseph Bresee. Registration is free, but limited. For registration information, go to: http://www2.cdc.gov/vaccines/ed/ciinc

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12.  Immunize Georgia conference scheduled for September 11

The 16th annual Immunize Georgia conference will take place on September 11 at Stone Mountain. The purpose of the conference is to provide the latest immunization information to healthcare providers who care for families, children, adolescents, and young adults.

For more information, download the conference brochure here.

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Immunization Action Coalition  •  Saint Paul, MN
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.