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Immunization Action Coalition

IAC Express 2006

Issue number 624: October 9, 2006

Contents of this Issue
  1. New: FDA approves additional influenza vaccine; it is intended for use in persons age 18 years and older
  2. 2005 NIS data indicate influenza vaccination rate for children ages 6-23 months doubled between 2003-4 and 2004-05
  3. CDC compares 2004 and 2005 BRFSS data on influenza and pneumococcal vaccination rates for adults age 65 and older
  4. 2005 NIS data indicate slight increase in hepatitis B vaccination rate of newborns compared with 2004 data
  5. New: October 2006 issue of Needle Tips offers many resources for childhood, adolescent, and adult immunization
  6. New: American Lung Association launches Faces of Influenza initiative
  7. New: IAC updates its "Notification of Vaccination Letter" with space for HPV and shingles vaccines
  8. Teleconference on addressing parents' concerns about vaccines scheduled for November 7
 
Abbreviations
AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NIP, National Immunization Program; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
  
Issue 624: October 9, 2006
1.  October 9, 2006
NEW: FDA APPROVES ADDITIONAL INFLUENZA VACCINE; IT IS INTENDED FOR USE IN PERSONS AGE 18 YEARS AND OLDER

On October 5, FDA issued a press release announcing that it has approved an additional influenza vaccine for use during the 2006-07 influenza season. The press release is reprinted below in its entirety.

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For immediate release
October 5, 2006

FDA APPROVES ADDITIONAL VACCINE FOR UPCOMING INFLUENZA SEASON

The U.S. Food and Drug Administration (FDA) today approved FluLaval, an influenza vaccine to immunize people 18 years of age and older against the disease caused by strains of influenza virus judged likely to cause seasonal flu in the Northern Hemisphere in 2006-2007. With the addition of FluLaval, there are now five FDA-licensed vaccines for the United States for the upcoming influenza season.

According to the Centers for Disease Control and Prevention (CDC), the manufacturers have projected making a total of about 115 million doses of influenza vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.

"FDA's Center for Biologics Evaluation and Research (CBER) has taken proactive steps, through additional scientific work and guidance development, to enable manufacturers to improve the science of developing vaccines," said Andrew C. von Eschenbach, MD, acting commissioner, Food and Drugs. "That work is paying off in heightened interest among product developers in entering this vital market."

Influenza, a contagious respiratory disease, is commonly called "the flu."

According to CDC, every year in the United States, on average: 5 to 20 percent of the population gets seasonal flu; more than 200,000 people are hospitalized from its complications; and about 36,000 people die.

FluLaval was approved using FDA's accelerated approval pathway, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of a product's effectiveness, reducing the time it takes for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine will decrease seasonal influenza disease after vaccination.

"The challenges of vaccine supply in past flu seasons, the broadening CDC recommendations for annual vaccination, and the threat of a future avian influenza pandemic, all emphasize the value of adding more manufacturers and production capacity. We all benefit from more high-quality flu vaccine manufacturers and increased supply," said Jesse L. Goodman, MD, MPH, director, CBER, FDA. "The successful use of accelerated approval illustrates both the value of tools that FDA has put into place to meet critical public health needs, and the benefits of intensive scientific interactions between FDA and manufacturers and advice from FDA during product development and evaluation."

Safety information was collected from two clinical studies involving about 1,000 adults who received FluLaval. Other data from use of the vaccine in Canada, where FluLaval has been available since 2001, were also evaluated as part of FDA's safety assessment. After vaccination, the rate and nature of side effects were similar to those seen with other licensed seasonal influenza vaccines. The most commonly reported side effects included pain, redness, and swelling at the injection site, and headache, fatigue, and cough.

The vaccine contains inactivated or "killed" virus and cannot cause flu. It is administered as a single injection in the upper arm. The vaccine is packaged in a multi-dose vial with thimerosal, a mercury derivative, as a preservative. The company has plans to develop a thimerosal-reduced or thimerosal-free formulation for studies in the pediatric population.

People who are allergic to eggs, chicken proteins, or any other components of the vaccine should not receive FluLaval. FluLaval has not been studied in children and pregnant women.

Seasonal influenza is a serious threat to public health. It can cause mild to severe illness, and at times can lead to death. Although no vaccine is 100 percent effective against preventing disease, vaccination is the best protection against seasonal influenza and can prevent many illnesses and deaths. It is best to be immunized in October or November, but getting the vaccine in the winter months when flu season often peaks is also recommended.

FluLaval is manufactured by ID Biomedical Corporation of Quebec, Canada, a subsidiary of GlaxoSmithKline Biologics and will be distributed by GlaxoSmithKline, Research Triangle Park, NC.

FluLaval is the second seasonal influenza vaccine approved using the accelerated approval process; GlaxoSmithKline's Fluarix received approval in 2005.

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To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01478.html

To read the package insert, go to:
http://www.fda.gov/cber/label/inflidb100506LB.pdf

To read the product approval letter, go to:
http://www.fda.gov/cber/approvltr/inflidb100506L.htm
 
 
 
 
 
2.  October 9, 2006
2005 NIS DATA INDICATE INFLUENZA VACCINATION RATE FOR CHILDREN AGES 6-23 MONTHS DOUBLED BETWEEN 2003-04 AND 2004-05

CDC published "Childhood Influenza Vaccination Coverage—United States, 2004-05 Influenza Season" in the October 6 issue of MMWR. A link to tables describing data collected during the 2005 National Immunization Survey (NIS) appears at the end of this IAC Express article.

Portions of the MMWR article are reprinted below.

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Children aged <2 years are at increased risk for influenza-related hospitalizations, and children aged 24-59 months are more likely than older children to visit a clinic, hospital, or emergency department with influenza-associated illness. In 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged annual influenza vaccinations for children aged 6-23 months (and for household contacts of and out-of-home caregivers for children aged <2 years). For the 2004-05 influenza season, ACIP strengthened its encouragement to a full recommendation. For the upcoming 2006-07 influenza season, ACIP has further extended its recommendation to include all children aged 6-59 months (and their household contacts and out-of-home caregivers). Others recommended to receive influenza vaccination include children aged 6-18 years who have certain high-risk medical conditions, are on chronic aspirin therapy, or who are household contacts of persons at high risk for influenza complications. This report provides an assessment of influenza vaccination coverage among children aged 6-23 months during the 2004-05 influenza season. The findings demonstrate that vaccination coverage in that age group approximately doubled from the 2003-04 influenza season, with substantial variability among states and urban areas. However, the percentage of fully vaccinated children remained low, underscoring the need for increased measures to improve pediatric vaccination coverage and ongoing monitoring of coverage among young children and their close contacts.

The findings in this report are based on data from the 2005 National Immunization Survey (NIS), which provides estimates of vaccination coverage among noninstitutionalized children aged 19-35 months at the time of household interview. For the 2005 reporting period, NIS included children born during February 2002-July 2004 with adequate provider data. The survey was conducted in all 50 states and selected urban areas. Complete influenza vaccination histories were obtained from children's vaccination providers.

Two measures of childhood influenza vaccination coverage for the 2004-05 season are reported: (1) receipt of 1 or more doses of influenza vaccine during September-December 2004 and (2) full vaccination (based on ACIP recommendations for 2 doses of influenza vaccine for children who had not received vaccine for a previous influenza season and 1 dose for children who had received influenza vaccine for a previous season). Children were considered fully vaccinated if they had (1) received no doses of influenza vaccine before September 1, 2004, but then received 2 doses from September 1 through the date of interview or January 31, 2005 (whichever came earlier), or (2) received 1 or more doses of influenza vaccine before September 1 and then received 1 or more doses during September-December 2004. Analyses for both measures included only those children who were aged 6-23 months during the entire span of September-December 2004. . . .

Substantial variability in influenza vaccination coverage was observed among states and surveyed urban areas. Percentages of children receiving 1 or more doses of influenza vaccine ranged from 9.1% (CI [confidence interval] = +/-5.2) in Clark County, Nevada, to 59.3% (CI = +/-9.1) in Massachusetts. Percentages of children who were fully vaccinated ranged from 3.3% (CI = +/-3.4) in Detroit, Michigan, to 35.5% (CI = +/-8.9) in Massachusetts.

Editorial Note:
The findings in this report indicate that, during the first season in which ACIP recommended routine annual influenza vaccination for children aged 6-23 months, coverage approximately doubled from the previous year. This increase in vaccination coverage from the 2003-04 to the 2004-05 influenza season likely was influenced by the change from an encouragement to a full recommendation. . . .

The findings in this report reveal that during the first year of the recommendation, the percentage of children aged 6-23 months who were fully vaccinated for influenza remained low. The importance of 2 doses of influenza vaccine for previously unvaccinated children aged <9 years was highlighted in a recent study. During the 2003-04 influenza season, vaccine effectiveness in preventing medically attended influenza-like illness (ILI) or pneumonia and influenza (P&I) in fully vaccinated children aged 6-23 months was determined to be 25% and 49%, respectively. In contrast, for children aged 6-23 months receiving 1 dose of influenza vaccine, no statistically significant reduction in ILI or P&I was determined. The maximum benefit from influenza vaccination is obtained when all recommended doses are administered before the onset of influenza activity in the community, which might be particularly difficult to achieve among children requiring 2 doses because of the minimum interval of 4 weeks required between doses. However, providers should routinely offer influenza vaccine throughout the influenza season, even after influenza activity has been documented in the community. . . .

This report underscores the need to continue monitoring annual influenza vaccination coverage among young children, including the newly recommended group aged 6-59 months. In addition, because protection of young children is enhanced by vaccination of household contacts and out-of-home caregivers, monitoring vaccination coverage among these persons also is important. . . .

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To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5539a1.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5539.pdf

To access NIS 2005 data tables from the CDC website, go to:
http://www.cdc.gov/nip/coverage/NIS/05/toc-05.htm

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
 
 
 
3.  October 9, 2006
CDC COMPARES 2004 AND 2005 BRFSS DATA ON INFLUENZA AND PNEUMOCOCCAL VACCINATION RATES FOR ADULTS AGE 65 AND OLDER

CDC published "Influenza and Pneumococcal Vaccination Coverage Among Persons Aged >/=65 Years—United States, 2004-2005" in the October 6 issue of MMWR. Portions of the article are reprinted below.

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Vaccination of persons at increased risk for complications from influenza and pneumococcal disease is a key public health strategy in the United States. During the 1990-1999 influenza seasons, approximately 36,000 deaths were attributed annually to influenza infection, with approximately 90% of deaths occurring among adults aged >/=65 years. In 1998, an estimated 3,400 adults aged >/=65 years died as a result of invasive pneumococcal disease. One of the Healthy People 2010 objectives is to achieve 90% coverage of noninstitutionalized adults aged >/=65 years for both influenza and pneumococcal vaccinations (objective 14-29). To assess progress toward this goal, this report examines vaccination coverage for persons interviewed in the 2004 and 2005 Behavioral Risk Factor Surveillance System (BRFSS) surveys. The 2004-05 influenza season was characterized by an influenza vaccine shortage. As a result, the Advisory Committee on Immunization Practices (ACIP) issued recommendations that influenza vaccine be reserved for persons in priority groups, including persons aged >/=65 years, and that others should defer vaccination until supply was sufficient. The results of this assessment indicated that, overall, influenza vaccination coverage was lower in the 2005 survey year than in 2004, whereas pneumococcal vaccination coverage was nearly unchanged from 2004 to 2005. In both years, influenza and pneumococcal vaccination coverage varied from state to state. Continued measures are needed to increase the proportion of older adults who receive influenza and pneumococcal vaccines; healthcare providers should offer pneumococcal vaccine all year and should continue to offer influenza vaccine during December and throughout the influenza season, even after influenza activity has been documented in the community. . . .

[In 2005, influenza] vaccination coverage levels ranged from 32.0% (Puerto Rico) to 78.2% (Minnesota), with a median of 65.5%. The median change in influenza vaccination coverage from the 2004 to the 2005 survey was -5.1%. In 16 states, the decline in influenza vaccination coverage was statistically significant (p<0.05). In 13 of the 16 states, the coverage decline was <10%.
. . .

[In 2005, pneumococcal] vaccination coverage ranged from 28.3% (Puerto Rico) to 71.7% (North Dakota), with a median of 65.7%. In three states, the increase in pneumococcal vaccination coverage from 2004 to 2005 was statistically significant, whereas one state had a statistically significant decline in pneumococcal vaccination coverage during this period. In the three states with a significant increase in coverage, the increase ranged from 6.8% to 10.5%. . . .

Editorial Note:
In the 2004 and 2005 BRFSS surveys, approximately 20% of persons aged >/=65 years who said they received influenza vaccine reported never having received a pneumococcal vaccination, indicating missed opportunities for pneumococcal vaccine administration at the time of influenza vaccination. Offering pneumococcal vaccine with influenza vaccination should facilitate improvement in pneumococcal vaccination coverage.

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To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5539a2.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5539.pdf
 
 
 
4.  October 9, 2006
2005 NIS DATA INDICATE SLIGHT INCREASE IN HEPATITIS B VACCINATION RATE OF NEWBORNS COMPARED WITH 2004 DATA

On September 28, the NIP website posted an Excel spreadsheet titled "Estimated Vaccination Coverage for Hepatitis B Vaccine Among Children from Birth to 2 Days of Age by State and Immunization Action Plan Area—National Immunization Survey, 2005." The data indicate the national average for a birth dose given within two days of life has risen slightly from a 2004 rate of 46.0 percent to a 2005 rate of 47.9 percent.

To access the spreadsheet, go to:
http://www.cdc.gov/nip/coverage/NIS/05/tab36_hepb_birth02.xls
 
 
 
5. 

October 9, 2006
NEW: OCTOBER 2006 ISSUE OF NEEDLE TIPS OFFERS MANY RESOURCES FOR CHILDHOOD, ADOLESCENT, AND ADULT IMMUNIZATION

IAC recently mailed the latest issue of Needle Tips (October 2006) to 160,000 health professionals and others who work in the field of immunization. Packed with immunization resources for health professionals, patients, and parents, the 24-page issue is well worth downloading. All articles and education pieces, except editorials, have been thoroughly reviewed by immunization and hepatitis experts at CDC.


HOW TO READ NEEDLE TIPS ON THE WEB
You can view selected articles from the table of contents below or download the entire issue from the Web.

To view the table of contents with links to individual articles, go to: http://www.immunize.org/nt

The PDF file of the entire issue, linked below, is 1.97 megabytes. For tips on downloading and printing PDF files, go to: http://www.immunize.org/nslt.d/tips.htm

To download a ready-to-print (PDF) version of the entire October issue, go to: http://www.immunize.org/nslt.d/n35/n35.pdf

The articles in the October issue fall into five broad areas: (1) general immunization information, (2) viral hepatitis information, (3) childhood and adolescent immunization resources, (4) adult immunization resources, and (5) influenza immunization resources.


GENERAL IMMUNIZATION INFORMATION (four resources) (1) In "Ask the experts," immunization and hepatitis experts from CDC answer questions about vaccines and their recommended use.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/nslt.d/n35/expert35.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/nslt.d/n35/expert35.htm

(2) The editorial "Read compelling case reports about vaccine-preventable diseases!" gives readers an overview of Unprotected People, IAC's online collection of articles and case reports about people with vaccine-preventable diseases at http://www.immunize.org/reports

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/nslt.d/n35/casereports.pdf

(3) "Vaccine highlights" presents information on recently published ACIP recommendations, newly licensed vaccines, and new and revised VISs.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/nslt.d/n35/vaccin35.pdf

(4) "If you administer vaccines, you need these materials" offers four resources: three patient screening questionnaires and one guideline for administering intramuscular and subcutaneous injections to persons across the life span. All can be downloaded.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/nslt.d/n35/administervacs.pdf


VIRAL HEPATITIS INFORMATION (one resource)
(1) Updated in August, "Hepatitis B and the healthcare worker" is a comprehensive, three-page Q&A about indications for healthcare worker hepatitis B vaccination, postvaccination serologic testing, and prophylaxis after occupational exposure to hepatitis B virus infection.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/catg.d/2109hcw.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/2109hcw.htm


CHILDHOOD AND ADOLESCENT IMMUNIZATION RESOURCES (one resource)
(1) The three-page chart "Summary of recommendations for childhood and adolescent immunization" was extensively revised in September with information about the new vaccines for HPV and rotavirus and the expanded age range for influenza vaccine.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/catg.d/rules1.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/nslt.d/n17/rules1.htm


ADULT IMMUNIZATION RESOURCES (one resource)
(1) The three-page chart "Summary of Recommendations for Adult Immunization" was updated in September with new information on using Td/Tdap vaccines during pregnancy and on new definitions of evidence of immunity to varicella.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/catg.d/p2011b.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/p2011b.htm


INFLUENZA IMMUNIZATION RESOURCES (two resources)
(1) Completely revised in September, "First do no harm: Protect patients by making sure all staff receive yearly influenza vaccine!" briefly reviews the sweeping changes found in the new ACIP recommendations for influenza vaccination of healthcare personnel and the new standard of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/catg.d/p2014.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/p2014.htm

(2) "Influenza vaccination standing orders and screening questionnaires" presents five resources: one sheet of information outlining which persons need influenza vaccine; two standing orders protocols for administering influenza vaccine (child/teen and adult); and two patient-screening questionnaires, one for injectable influenza vaccine and one for intranasal vaccine. All can be downloaded.

To access a ready-to-print (PDF) version, go to:
http://www.immunize.org/nslt.d/n35/flu_so.pdf

 
 
 
6.  October 9, 2006
NEW: AMERICAN LUNG ASSOCIATION LAUNCHES FACES OF INFLUENZA INITIATIVE

On September 19, the American Lung Association (ALA) issued a press release announcing the kick-off of an initiative to increase public awareness of the health consequences of influenza disease and the importance of vaccination. Called the Faces of Influenza, the initiative brings together celebrities, public health officials, and everyday people who share personal stories about their experiences with the disease and encourage influenza vaccination among the groups for whom vaccination is recommended. Emmy-nominated actress Jean Smart, who has diabetes, is the initiative's national spokesperson.

Portions of the press release are reprinted below.

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Influenza immunization rates fall far short every year, even though health experts recommend more than 200 million people in the U.S. receive an annual influenza vaccination. The American Lung Association today launched the Faces of Influenza, a multi-year national public awareness initiative to help Americans put a "face" on this serious disease and recognize annual influenza immunization as an important preventative measure to protect themselves and their families every year. . . .

The Lung Association is . . . working with everyday Americans from across the country, including two families who lost their children to influenza—one a twin boy, who died at six months of age; the other a healthy four-year-old girl. Others in the program have asthma, diabetes, or other chronic medical conditions, like chronic obstructive pulmonary disease (COPD). One is pregnant, and participates to help stress the importance of immunization for women who will be pregnant during influenza season. There are also photos of health care providers, who should be immunized every year to protect themselves and their patients.

The initiative also includes educational materials as well as the national distribution of new television and radio public service announcements featuring Jean Smart and the target groups recommended for influenza immunization. The Lung Association has developed a new website, www.facesofinfluenza.org, where consumers and health care providers can find more information about influenza and the importance of immunization. Visitors to the website can also view the photographs and stories featured in the Faces of Influenza Portrait Gallery, view the public service campaign, and utilize the Lung Association's Flu Clinic Locator (the largest online directory of public influenza clinics). . . .

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To access the complete press release, go to: http://www.lungusa.org and click on the title "American Lung Association launches national influenza initiative to encourage Americans to see themselves among the Faces of Influenza."

To access the Faces of Influenza website, go to: http://www.facesofinfluenza.org and click on the words Enter Site.
 
 
 
7.  October 9, 2006
NEW: IAC UPDATES ITS "NOTIFICATION OF VACCINATION LETTER" WITH SPACE FOR HPV AND SHINGLES VACCINES

The Immunization Action Coalition (IAC) recently revised its prototype "Notification of Vaccination Letter." The prototype letter lists the vaccines often administered to children and adults. IAC has updated it with space for recording administration of the new human papillomavirus (HPV) vaccine and the new shingles vaccine.

A clinic, private practice, or immunization clinic can modify the letter and use it to notify a patient's primary clinic that the patient was vaccinated.

To access a ready-to-print (PDF) version of the revised prototype letter, go to:
http://www.immunize.org/catg.d/p3060not.pdf
 
 
 
8.  October 9, 2006
TELECONFERENCE ON ADDRESSING PARENTS' CONCERNS ABOUT VACCINES SCHEDULED FOR NOVEMBER 7

The National Immunization Coalition TA [technical assistance] Network has scheduled a teleconference that will focus on addressing parents' concerns about vaccines. It will be held at 1:00PM, ET, November 7. The presenter is Gary Marshall, MD, professor of pediatrics, University of Louisville School of Medicine.

To register for the teleconference, send an email to IZTA@aed.org Include this message: "Sign me up for the parent's concerns call."

For additional information, or to access earlier programs, go to: http://www.izcoalitionsta.org/confcall.cfm
 
 
 
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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.