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IAC Express 2007 |
| Issue number 686: October 1, 2007 |
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Contents
of this Issue
Select a title to jump to the article. |
- FDA
approves Afluria, a new inactivated influenza vaccine for use in people
age 18 years and older
- NEJM
publishes three articles related to thimerosal in vaccines
- Interim
VIS for hepatitis B vaccine now available in Spanish
- CDC
reports on national and global influenza activity during May 20-September
15, 2007
-
Proceedings from the June 27-28 ACIP meeting now online
- WHO's
"World Health Report 2007" focuses on building a safer future through
international public health cooperation
- Snap
Shots, an electronic newsletter of USAID, offers readers an international
perspective on immunization
- ICEID to
be held in Atlanta on March 16-19, 2008; abstracts due November 19
- Vermont
Department of Health schedules immunization conference for October 30 in
Stowe, VT
- The
journal Vaccine to celebrate its 25th anniversary at the Vaccine Congress
in Amsterdam on December 9-11
- Seminar
on infectious diseases modeling scheduled for December 10-12 in Annecy,
France
- CDC
publishes update on global activity of vaccine-derived polioviruses during
January 2006-August 2007
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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; 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. |
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Issue 686: October 1, 2007 |
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1. |
FDA approves Afluria, a new inactivated influenza vaccine for use in people
age 18 years and older
On September 28, FDA issued a press release
announcing its approval of Afluria (manufactured by CSL Limited), an
inactivated influenza virus vaccine. It is indicated for active immunization
of adults age 18 years and older against influenza disease caused by
influenza virus type A and type B present in the vaccine. The press release
is reprinted below in its entirety. Links to the approval letter and the
package insert appear at the end of this IAC Express article.
ADDITIONAL INFLUENZA VACCINE APPROVED FOR UPCOMING INFLUENZA
SEASON
Approval increases available doses to record level
The U.S. Food and Drug Administration today approved Afluria, an
additional seasonal influenza vaccine for the immunization of
people ages 18 and older.
Afluria is intended to protect adults from influenza type A and
type B flu viruses. Influenza is a contagious respiratory
illness that can cause annual epidemics.
The approval of Afluria, manufactured by CSL Limited of
Parkville, Australia, brings the number of seasonal influenza
manufacturers licensed for the U.S. market to six.
Based on current manufacturing trends, the Centers for Disease
Control and Prevention estimates that the six manufacturers will
supply a record 132 million doses of influenza vaccine for the
2007-2008 influenza season.
"Routine immunization is the most effective way to prevent
influenza and decrease influenza-related complications which can
include serious illness and death," said Jesse L. Goodman, MD,
MPH, director of FDA's Center for Biologics Evaluation and
Research. "The licensure of this additional manufacturer
contributes to having an adequate supply of seasonal influenza
vaccine for Americans, one of FDA's highest priorities."
Flu season in the United States can begin as early as October
and can last as late as May, according to the CDC. Every year in
the United States, more than 200,000 people are hospitalized
with influenza and about 36,000 people die from its
complications. While it is best to be immunized as soon as the
vaccine is available, usually in September, getting a flu shot
any time during influenza season is also appropriate because the
influenza season often peaks late.
Afluria was approved using FDA's accelerated approval pathway
for serious or life-threatening diseases, which reduces the time
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 decreases seasonal influenza disease
after vaccination.
The most commonly reported adverse events were tenderness, pain,
redness and swelling at the injection site, and headache,
fatigue and muscle aches.
Afluria contains inactivated influenza viruses grown in chicken
eggs. People who are allergic to eggs or any other component of
the vaccine should not receive Afluria.
The vaccine is administered as a single injection in the upper
arm, and is available in both a single-dose, preservative-free,
pre-filled syringe and a multi-dose vial with thimerosal, a
mercury derivative, as a preservative.
To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.html
To access the approval letter, go to:
http://www.fda.gov/cber/approvltr/afluria092807L.htm
To access the package insert, go to:
http://www.fda.gov/cber/label/afluriaLB.pdf
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2. |
NEJM publishes three articles
related to thimerosal in vaccines
In its September 27 issue, the
New England Journal of Medicine
(NEJM) published one research article and two editorials about
thimerosal in childhood vaccines.
The research article is titled "Early Thimerosal Exposure and
Neuropsychological Outcomes at 7 to 10 Years." The abstract is
reprinted below; a link to the complete article is given at the
end of this IAC Express article.
One of the editorials, "Thimerosal and Vaccines--A Cautionary
Tale," is written by Paul A. Offit, MD. It provides essential
background information on the thimerosal controversy, making it
useful to those who communicate about vaccine safety issues. The
other editorial, "Cases in Vaccine Court--Legal Battles over
Vaccines and Autism," is written by Stephen D. Sugarman, JD. It
comments on the legal processing of parents' claims that
vaccination has caused their children's health problems. Links
to both editorials are given at the end of this IAC Express
article.
CDC and professional associations have posted information on
their websites related to the findings in the research article.
Links to those postings are given at the end of this IAC Express
article.
ABSTRACT
Background: It has been hypothesized that early exposure to
thimerosal, a mercury-containing preservative used in vaccines
and immune globulin preparations, is associated with
neuropsychological deficits in children.
Methods: We enrolled 1,047 children between the ages of 7 and 10
years and administered standardized tests assessing 42
neuropsychological outcomes. (We did not assess autism-spectrum
disorders.) Exposure to mercury from thimerosal was determined
from computerized immunization records, medical records,
personal immunization records, and parent interviews.
Information on potential confounding factors was obtained from
the interviews and medical charts. We assessed the association
between current neuropsychological performance and exposure to
mercury during the prenatal period, the neonatal period (birth
to 28 days), and the first 7 months of life.
Results: Among the 42 neuropsychological outcomes, we detected
only a few significant associations with exposure to mercury
from thimerosal. The detected associations were small and almost
equally divided between positive and negative effects. Higher
prenatal mercury exposure was associated with better performance
on one measure of language and poorer performance on one measure
of attention and executive functioning. Increasing levels of
mercury exposure from birth to 7 months were associated with
better performance on one measure of fine motor coordination and
on one measure of attention and executive functioning.
Increasing mercury exposure from birth to 28 days was associated
with poorer performance on one measure of speech articulation
and better performance on one measure of fine motor
coordination.
Conclusions: Our study does not support a causal association
between early exposure to mercury from thimerosal-containing
vaccines and immune globulins and deficits in neuropsychological
functioning at the age of 7 to 10 years.
To access the complete research article, go to:
http://content.nejm.org/cgi/content/short/357/13/1281
To access Paul A. Offit's editorial, go to:
http://content.nejm.org/cgi/content/full/357/13/1278
To access Stephen D. Sugarman's editorial, go to:
http://content.nejm.org/cgi/content/full/357/13/1275
To access a transcript of a CDC press briefing related to the
research article, go to:
http://www.cdc.gov/od/oc/media/transcripts/2007/t070926.htm
To access a posting related to the research article from the
website of the National Network for Immunization Information, go
to:
http://www.immunizationinfo.org/immunization_science_detail.cfv?id=131
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3. |
Interim VIS for hepatitis B
vaccine now available in Spanish
The current version of the
interim VIS for hepatitis B vaccine,
dated 7/18/07, is now available on the IAC website in Spanish.
IAC gratefully acknowledges the California Department of Public
Health, Immunization Branch, for the translation.
To obtain a ready-to-print (PDF) version of the interim VIS for
hepatitis B vaccine in Spanish, go to:
http://www.immunize.org/vis/sphepb01.pdf
To obtain it in English, go to:
http://www.immunize.org/vis/hepb01.pdf
For information about the use of VISs, and for VISs in more than
30 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
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4. |
CDC reports on national and global influenza activity during May 20-September
15, 2007
CDC published "Update: Influenza
Activity--United States and
Worldwide, May 20-September 15, 2007" in the September 28 issue
of MMWR. Portions of the article are reprinted below.
During May 20-September 15, 2007, influenza A (H1), influenza A
(H3), and influenza B viruses co-circulated worldwide and were
identified sporadically in the United States. This report
summarizes influenza activity in the United States and worldwide
since the last MMWR update. . . .
During May 20-September 15, data from the U.S. Influenza
Sentinel Provider Surveillance System indicated that the weekly
percentage of patient visits to U.S. sentinel providers for
influenza-like illness (ILI) remained below the national
baseline of 2.1% and ranged from 0.6% to 1.0%. The percentage of
deaths attributed to pneumonia and influenza (P&I) as reported
by the 122 Cities Mortality Reporting System was below the
epidemic threshold. One influenza-associated pediatric death
occurred during June and was reported to the Influenza-Associated Pediatric Mortality Reporting System.
Two human cases of novel influenza A were reported to the
National Notifiable Diseases Surveillance System (NNDSS). Both
persons were infected with swine influenza virus and were
infected by handling ill pigs at a county fair in Ohio. Both
recovered from their illness. . . .
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5638a4.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5638.pdf
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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5. |
Proceedings from the June 27-28 ACIP meeting now online
The CDC website recently posted
the Record of the Proceedings of
ACIP's June 27-28 meeting. To access a ready-to-print (PDF)
version of the proceedings, go to:
http://www.cdc.gov/vaccines/recs/acip/downloads/min-jun07.pdf
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6. |
WHO's "World Health Report 2007" focuses on building a safer future through
international public health cooperation
WHO's "World Health Report
2007--A safer future: global public
health security in the 21st century" shows how the world is at
increasing risk of disease outbreaks, epidemics, industrial
accidents, natural disasters, and other health emergencies that
can rapidly become threats to global public health security. The
report explains how the revised International Health Regulations
(2005), which came into force this year, helps countries work
together to identify risks and act to contain and control them.
For additional information, including links to the complete
report and to individual report chapters, go to:
http://www.who.int/whr/2007/en
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7. |
Snap Shots, an electronic newsletter of USAID, offers readers an
international perspective on immunization
Snap Shots, an electronic
publication of USAID's
IMMUNIZATIONbasics Project, is intended to provide busy public
health professionals with references and periodic updates from
the immunization world. Although the primary audience for Snap
Shots is USAID (U.S. Agency for International Development)
health staff and staff of USAID-funded projects, other
immunization professionals will find it an excellent way to gain
an international perspective on immunization.
To access the current and back issues of Snap Shot, go to:
http://www.immunizationbasics.jsi.com/Newsletter/SnapShotsArchive.htm
To subscribe, go to:
http://www.immunizationbasics.jsi.com/Newsletter/Subscribe.htm
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8. |
ICEID to be held in Atlanta on March 16-19, 2008; abstracts due November 19
The International Conference on
Emerging Infectious Diseases
(ICEID) is scheduled for March 16-19, 2008, in Atlanta. ICEID
brings together public health professionals to encourage the
exchange of scientific and public health information on global
emerging infectious disease issues.
Abstracts must be submitted electronically by November 19, 2007.
For more information about abstract submission, go to:
http://www.iceid.org/abstracts-cfa.asp
For a comprehensive overview of the conference, go to:
http://www.iceid.org or contact
iceid@asmusa.org
or (202) 942-9330.
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9. |
Vermont Department of Health schedules immunization conference for October 30 in
Stowe, VT
This one-day conference is
intended for Vermont healthcare
professionals involved in any aspect of immunization, including
education, compliance, and administration. The keynote speaker
is Andrew Kroger, MD, MPH, of CDC's National Center for
Immunization and Respiratory Diseases.
To download the conference brochure, which includes a
registration form, go to:
http://healthvermont.gov/documents/103007conferencebrochure.pdf
For additional information, contact Miriam Sheehey, RN VFC, at
(802) 865-7755 or msheehe@vdh.state.vt.us
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10. |
The journal Vaccine to celebrate its 25th anniversary at the Vaccine Congress
in Amsterdam on December 9-11
The journal Vaccine will
celebrate its 25th anniversary at the
first Vaccine Congress, which will be held in Amsterdam on
December 9-11.
For complete details, including links to program and
registration information, go to: http://www.vaccinecongress.com
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11. |
Seminar on infectious diseases modeling scheduled for December 10-12 in
Annecy, France
A seminar on infectious disease
modeling is planned for December
10-12 at Les Pensieres Conference Center, Annecy, France. The
program will be conducted in English.
To access the seminar program and registration form, go to:
http://www.fondation-merieux.org/en/knowledge/conferences/conferences.php
Scroll down and click on the pertinent link(s) in the section
titled "Advances in modelisation for infectious diseases."
For additional information, email Catherine Dutel at
catherine.dutel@fondation-merieux.org
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12. |
CDC publishes update on global activity of vaccine-derived polioviruses
during January 2006-August 2007
CDC published "Update on
Vaccine-Derived Polioviruses--Worldwide, January 2006-August 2007" in the September 28 issue
of MMWR. Portions of an article synopsis made available to the
press are reprinted below.
Vaccine-derived polioviruses (VDPVs), fall into three
categories: (1) circulating VDPVs (cVDPVs) from outbreaks, (2)
primary immunodeficiency-associated VDPVs (iVDPVs) from patients
with defects in antibody production, and (3) ambiguous VDPVs
(aVDPVs) for which there is insufficient evidence for definitive
assignment to the other two categories. In 2005-2007, cVDPVs
were found in Nigeria (type 2; 69 cases), Niger (two cases;
importation from Nigeria), Cambodia (type 3; two cases), and
Myanmar (type 1; four cases). In 2005-2007, iVDPVs were found in
China, Iran, Syria, Egypt, and Kuwait, and aVDPVs were found in
China and Israel.
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5638a3.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5638.pdf
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