IAC Express 2006 |
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Issue number 624: October 9, 2006 |
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Contents
of this Issue |
- New: FDA approves additional influenza
vaccine; it is intended for use in persons age 18 years and older
- 2005 NIS data indicate influenza
vaccination rate for children ages 6-23 months doubled between 2003-4 and
2004-05
- CDC compares 2004 and 2005 BRFSS data on
influenza and pneumococcal vaccination rates for adults age 65 and older
- 2005 NIS data indicate slight increase in
hepatitis B vaccination rate of newborns compared with 2004 data
- New: October 2006 issue of Needle Tips
offers many resources for childhood, adolescent, and adult immunization
- New: American Lung Association launches
Faces of Influenza initiative
- New: IAC updates its "Notification of
Vaccination Letter" with space for HPV and shingles vaccines
- Teleconference on addressing parents'
concerns about vaccines scheduled for November 7
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Abbreviations |
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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. |
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| Issue 624: October
9,
2006 |
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| 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.
********************
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
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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 |
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| 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 |
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| 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 |
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| 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 |
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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). . . .
************
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
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| 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 |
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| 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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