Issue
Number 436
January 12, 2004
CONTENTS OF THIS ISSUE
- MedImmune and Wyeth announce changes in the storage
requirements for FluMist influenza vaccine
- CDC issues an update on influenza-related deaths among
children age <18 years during the current influenza season
- CDC website posts guidance for prevention and control of
influenza in peri- and postpartum settings
- CDC issues an update on influenza activity during December 21,
2003-January 3, 2004
- NEJM publishes an article on factors influencing the decision
to receive meningococcal vaccine
- Get continuing education credit for CDC's immunization
self-study courses and ACIP statements
- Reminder: January 12 is the registration deadline for CDC's
Netconference "Current Issues in Immunization"
- Reminder: January 16 is the deadline to submit abstracts for
the National Immunization Conference
- "Mass Vaccination Clinics" satellite broadcast scheduled for
March 18
- World Vaccine Congress to be held April 27-29 in Montreal
- International AIDS Conference scheduled for July 11-16 in
Bangkok
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ABBREVIATIONS: 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; WHO, World Health Organization.
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January 12, 2004
MEDIMMUNE AND WYETH ANNOUNCE CHANGES IN THE STORAGE REQUIREMENTS FOR FLUMIST
INFLUENZA VACCINE
On December 31, 2003, MedImmune and Wyeth Vaccines announced changes in the
storage requirements for FluMist live attenuated influenza vaccine. The
storages changes have FDA approval. The announcement, addressed to health
care professionals, is reprinted below in its entirety.
************************
IMPORTANT PRESCRIBING INFORMATION
December 31, 2003
Dear Health Care Professional:
Subject: FluMist Storage Information
In an effort to enable wider and prompt distribution of FluMist, Influenza
Virus Vaccine Live, Intranasal, and to expand the number of vaccine
providers, MedImmune and Wyeth have taken steps to make it easier for
physicians and pharmacists to store the product. Based on new data showing
that FluMist remains stable for at least 3 months in conventional frost-free
freezers without the use of a freezer insert (known as the FluMist FreezeBox),
FDA has approved a supplement to our license for a modification of the
storage requirements FOR DOSES OF FLUMIST SHIPPED BETWEEN DECEMBER 31, 2003,
AND MARCH 31, 2004. These changes in storage requirements are not applicable
to FluMist doses currently stored in the FluMist FreezeBox.
Effective immediately, FluMist received after December 31, 2003, may be
stored in its packaging in a frost-free freezer WITHOUT the use of a FluMist
FreezeBox until March 31, 2004. Of note:
FluMist received after December 31, 2003, can be stored in a conventional
frost-free refrigerator/freezer combination unit (i.e., a refrigerator with
a separate, isolated freezer section) WITHOUT a FluMist FreezeBox. In such
units, the temperature setting for the freezer compartment should ideally be
set at a low level, while the temperature setting for the refrigerator
compartment should ideally be set at the midpoint.
FluMist CANNOT be stored in dorm-style refrigerator/freezer units (i.e., a
refrigerator not having a separate isolated freezer section).
Physicians and pharmacists who wish to continue using the FreezeBox or a
manual defrost freezer may certainly do so; in which case the imprinted
expiration date on the sprayer remains in effect.
All unused doses of FluMist shipped between December 31, 2003 and March 31,
2004 and stored in a frost-free freezer without a FluMist FreezeBox must
either be returned or discarded effective March 31, 2004, regardless of the
expiration date imprinted on the sprayer.
In mid-March, Wyeth and MedImmune will send a reminder letter on this policy
to all health care professionals receiving FluMist doses after December 31,
2003.
Please note that this change in the storage requirements for FluMist applies
only to doses of THIS SEASON'S VACCINE SHIPPED BETWEEN DECEMBER 31, 2003 AND
MARCH 31, 2004. MedImmune will provide additional data to the FDA in order
to determine storage requirements for FluMist for the 2004-05 influenza
season. If you already have a FluMist FreezeBox, a representative will be in
contact at the end of the influenza season to provide direction on how to
store or return your FreezeBox. Please see accompanying Prescribing
Information for indications and usage, dosage and administration, and safety
information.
Should you have any questions regarding this information, please contact us
at (800) 411-0086. To order FluMist, please call (800) 358-7443.
Sincerely,
Peter A. Patriarca, MD
Vice President, Regulatory Affairs
MedImmune Vaccines, Inc.
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January 12, 2004
CDC ISSUES AN UPDATE ON INFLUENZA-RELATED DEATHS AMONG CHILDREN AGE <18
YEARS DURING THE CURRENT INFLUENZA SEASON
The Centers for Disease Control and Prevention (CDC) published "Update:
Influenza-Associated Deaths Reported Among Children Aged <18 Years--United
States, 2003-04 Influenza Season" in the January 9 issue of MMWR. The update
indicates that since October 2003, 93 influenza-related deaths among
children age <18 years have been reported to CDC. The update is reprinted
below in its entirety, excluding one figure, two tables, and references.
***********************
During the 2003-04 influenza season, CDC has received reports from state
health departments regarding deaths among children with evidence of
influenza virus infection. To help investigate these deaths, CDC has
requested that all influenza-associated deaths among children aged <18 years
be reported to CDC through state and local health departments during the
2003-04 season. This summary is based on preliminary data reported from 31
states as of January 6, 2004, and updates a previous report published in
MMWR.
Since October 2003, a total of 93 influenza-associated deaths among children
aged <18 years have been reported to CDC. All patients had evidence of
influenza virus infection detected by rapid antigen testing or other
laboratory tests.
The date of death was reported for 92 of the 93 cases. The median age of the
93 children was 4 years (range: 4 weeks-17 years), with 55 (59%) children
aged <5 years and 24 (26%) aged 6-23 months. Among the 92 children whose sex
was reported, 41 (45%) were male. A total of 35 (38%) of the 93 children
were reported to have had underlying chronic medical conditions, and 41
(44%) were reported to have had no underlying conditions; the medical
history was unknown for 17 (18%) children. Of the 55 children for whom the
location of death was reported, 15 (27%) died at home, 12 (22%) died in
emergency departments, 25 (45%) died as inpatients, and three (5%) died in
transport to hospitals.
Pneumonia was a reported complication in 25 of the 93 children. Invasive
bacterial co-infections were reported in 15 children, including methicillin-resistant
Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes,
Enterococcus sp., Haemophilus influenzae (type b and non-typable), Neisseria
meningitidis, Escherichia coli, Pseudomonas aeruginosa, Klebsiella
pneumoniae, and Serratia marcescens.
Of the 45 children whose influenza vaccination status was reported, one
child had evidence of adequate vaccination, whereas 33 (73%) were not
vaccinated, and six children were partially vaccinated (i.e., they had
received 1 of 2 doses); five children were reported as vaccinated, but the
interval between vaccination and onset of illness was not documented.
Influenza A viruses were isolated from respiratory specimens collected from
28 patients. A total of 55 children had influenza virus infection confirmed
by rapid antigen testing and direct fluorescent antibody staining of
respiratory specimens. Four additional children had influenza virus
infection confirmed solely by reverse transcriptase polymerase chain
reaction (RT-PCR) of respiratory specimens.
A total of 16 children with evidence of influenza virus infection by
culture, rapid antigen detection test, or RT-PCR also had autopsy specimens
tested at CDC by immunohistochemical (IHC) staining. Of these, 11 had
influenza A viral antigen detected by IHC staining in respiratory epithelium
of airway tissue specimens. In addition, autopsy tissue specimens from four
of 11 pediatric deaths without previous laboratory confirmation of influenza
virus infection were positive by IHC staining for influenza A viral antigen.
Editorial Note:
During October 11, 2003-January 6, 2004, a total of 93 influenza-associated
deaths among children aged <18 years were reported to CDC. Of the 51 deaths
that were not reported previously, 26 occurred before publication of the
previous report.
Because laboratory-confirmed influenza illnesses and deaths among children
are not nationally reportable conditions, the numbers of deaths reported
this season cannot be compared directly with previous influenza seasons, and
the proportion of illnesses associated with death cannot be estimated.
Heightened awareness of severe complications and deaths associated with
influenza among children this season and increased testing might be
contributing to identification of more pediatric fatalities related to
influenza than in previous seasons.
These reports underscore the need to further characterize the impact of
influenza among children. In addition to initiating voluntary reporting of
influenza-associated deaths, CDC is developing studies in collaboration with
health departments and other partners to estimate the rates of
influenza-associated hospitalization and serious complications and to
identify risk factors for severe illness and complications during the
current season. Additional studies are planned to assess the relative
severity of this season by comparing influenza-associated hospitalizations
and mortality among children with those in previous seasons. Such
information might be helpful in evaluating current pediatric influenza
vaccination recommendations.
Clinicians should consider influenza testing in children who have severe
febrile illness, when influenza viruses are circulating in their local
community. Clinicians should recognize that secondary conditions such as
bacterial infection can complicate some cases of influenza. Susceptibility
testing of bacterial isolates is important to guide appropriate antibiotic
therapy. Guidelines for antiviral treatment of influenza have been
published.
CDC Request for Reports of Influenza-Associated Deaths Among Children
During the 2003-04 influenza season, CDC is requesting that all
influenza-associated deaths among children aged <18 years be reported to CDC
through state and local health departments. In addition, CDC is requesting
submission of postmortem tissue specimens and autopsy reports when
available. Influenza viral isolates in fatal cases also should be sent to
CDC for antigenic characterization.
To report the influenza-associated death of a child aged <18 years, state
and local health departments should contact CDC's Influenza Branch,
telephone, (800) 232-4636; e-mail,
eocinfluenza@cdc.gov Case reporting forms are available to state and
local health departments and medical examiners via the Epidemic Information
Exchange (Epi-X), accessible at
http://www.cdc.gov/mmwr/epix/epix.html Completed forms should be
sent to CDC with a cover sheet with the heading, "ATTN: Fatal Case
Reporting" via fax, (888) 232-1322.
***********************
To access a web-text (HTML) version of the complete article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5253a4.htm
To access a ready-to-copy (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5253.pdf
Receive a FREE electronic subscription to MMWR (which includes new ACIP
statements) by going to
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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January 12, 2004
CDC WEBSITE POSTS GUIDANCE FOR PREVENTION AND CONTROL OF INFLUENZA IN PERI-AND
POSTPARTUM SETTINGS
On December 24, 2003, CDC added "Interim Guidance for Prevention and Control
of Influenza in the Peri- and Postpartum Settings" to its influenza web
page.
To access a web-text (HTML) version of the guidelines, go to:
http://www.cdc.gov/flu/professionals/peripostpartumguid.htm
To access a ready-to-copy version, go to:
http://www.cdc.gov/flu/professionals/pdf/peripostpartumguid.pdf
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January 12, 2004
CDC ISSUES AN UPDATE ON INFLUENZA ACTIVITY DURING DECEMBER 21, 2003-JANUARY
3, 2004
The Centers for Disease Control and Prevention (CDC) published "Update:
Influenza Activity--United States, December 21, 2003-January 3, 2004" in the
January 9 issue of MMWR. Portions of the update are reprinted below.
***********************
The number of states reporting widespread influenza activity decreased
during December 21, 2003-January 3, 2004. During the latest reporting week,
ending January 3, health departments in 38 states, the District of Columbia,
and New York City reported widespread influenza activity. Nine states
reported regional activity, one state reported local activity, and one state
and Guam reported sporadic activity. The percentage of outpatient visits for
influenza-like illness (ILI) decreased in all surveillance regions during
the week ending January 3, with an overall national percentage of 6.2%. This
percentage is above the national baseline of 2.5%. The percentage of
specimens testing positive for influenza also decreased; however, the
percentage of deaths attributed to pneumonia and influenza (P&I) increased.
. . .
Antigenic Characterization
Of the 461 influenza viruses collected by U.S. laboratories since October 1,
2003, and characterized antigenically by CDC, 454 were influenza A (H3N2)
viruses, two were influenza A (H1) viruses, and five were influenza B
viruses. The hemagglutinin proteins of the influenza A (H1) viruses were
similar antigenically to the hemagglutinin of the vaccine strain A/New
Caledonia/20/99. Of the 454 influenza A (H3N2) isolates that have been
characterized, 98 (21.6%) were similar antigenically to the vaccine strain
A/Panama/2007/99 (H3N2), and 356 (78.4%) were similar to a drift variant, A/Fujian/411/2002
(H3N2). Four influenza B viruses characterized were similar antigenically to
B/Sichuan/379/99, and one was similar antigenically to B/Hong Kong/330/2001.
P&I Mortality Surveillance
During the reporting week of December 21-December 27, 2003, P&I accounted
for 9.0% of all deaths reported through the 122 Cities Mortality Reporting
System and increased to 9.4% during the reporting week of December 28,
2003-January 3, 2004. The epidemic threshold was 7.9% and 8.0% for each
reporting week, respectively. . . .
Weekly updates on influenza activity will be published in MMWR during the
influenza season. Additional information about influenza activity is
available from CDC at
http://www.cdc.gov/flu
***********************
To access a web-text (HTML) version of the complete article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5253a5.htm
To access a ready-to-copy (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5253.pdf
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January 12, 2004
NEJM PUBLISHES AN ARTICLE ON FACTORS INFLUENCING THE DECISION TO RECEIVE
MENINGOCOCCAL VACCINE
Written by Paul A. Offit, MD, and Georges Peter, MD, "The Meningococcal
Vaccine--Public Policy and Individual Choices" was published in the "New
England Journal of Medicine" (NEJM) on December 11, 2003. The opening three
paragraphs are reprinted below, excluding references.
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On December 11, 2002, a 12-year-old girl from suburban Philadelphia died as
a result of serogroup C meningococcal infection. Death occurred within hours
after the initial manifestation of the illness. Her parents learned
subsequently that a vaccine was available that might have prevented their
daughter's death. They asked, "Why didn't we know about this vaccine?"
An estimated 2200 to 3000 cases of invasive meningococcal infection occur
every year in the United States. The incidence of meningococcal infections
is low as compared with that of other infections, but meningococcal
infection is characterized by a rapid onset, a case fatality rate of 10
percent, a rate of sequelae of 11 to 19 percent, and a capacity to inspire
fear in a community. A vaccine to prevent meningococcal infections has been
available in the United States for more than 20 years and is given to all
military recruits. Although receipt of the meningococcal vaccine is not
routinely recommended by the Centers for Disease Control and Prevention
(CDC) and the American Academy of Pediatrics, parents could reasonably
choose to have older children receive it. However, most parents do not know
that a vaccine is available to prevent meningococcal infections.
In this article, we discuss the different factors that are considered when
decisions are made about public and individual health and the way in which
recommendations by public health agencies affect the availability of
information required to make individual choices. These issues are explored
in relation to the question of why most parents do not know about the
meningococcal vaccine.
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To obtain a web-text (HTML) version of the article from the NEJM website, go
to:
http://www.chop.edu/consumer/jsp/division/generic.jsp?id=75734 You
will be taken to the meningococcus vaccine web page on the website of the
Vaccine Education Center, Children's Hospital of Philadelphia. Click on
"view more" in the right column, and you will be taken to the article on the
NEJM website.
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January 12, 2004
GET CONTINUING EDUCATION CREDIT FOR CDC'S IMMUNIZATION SELF-STUDY COURSES
AND ACIP STATEMENTS
CDC offers 12 immunization self-study courses on its website; continuing
education credit is available for most of them. In addition, continuing
education credit is available for reading many ACIP statements and
completing the brief test at the end of the statement.
SELF-STUDY CONTINUING EDUCATION CREDIT
To access information on the immunization self-study courses, go to:
http://www.cdc.gov/nip/ed/_video_selfstudy.htm
To speak with someone about the content of any of the courses, call the
National Immunization Information Hotline at (800) 232-2522.
To speak with someone about continuing education credit, call the Public
Health Training Network at (800) 418-7246.
ACIP CONTINUING EDUCATION CREDIT
To get credit for reading ACIP statements, download the ready-to-copy (PDF)
version of a statement and complete the test that appears at the end
(web-text [HTML] versions of ACIP statements do not include a test). If the
cover page of the PDF version displays this phrase, "Inside: Continuing
Education Examination," the statement includes a test.
To download individual ACIP statements from the CDC website, go to:
http://www.cdc.gov/mmwr/mmwr_rr.html
You can also download individual statements from the IAC website by going to
http://www.immunize.org/acip
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January 12, 2004
REMINDER: JANUARY 12 IS THE REGISTRATION DEADLINE FOR CDC'S
NETCONFERENCE "CURRENT ISSUES IN IMMUNIZATION"
Scheduled for January 15, from noon to 1 pm ET, the
Netconference "Current Issues in Immunization" is designed to
provide clinicians with up-to-date information on immunization.
It will focus on two topics: influenza and vaccine storage and
handling.
The conference requires pre-registration. Registration will
close when the course is full or on January 12 (midnight eastern
time).
To register for the conference, go to:
http://www2a.cdc.gov/nip/isd/ciinc/default.asp
For additional information, go to:
http://www.cdc.gov/nip/ed/ciinc/default.htm or call
(404) 639-8225.
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January 12, 2004
REMINDER: JANUARY 16 IS THE DEADLINE FOR SUBMITTING ABSTRACTS
FOR THE NATIONAL IMMUNIZATION CONFERENCE
January 16 is the deadline for submitting abstracts for the
National Immunization Conference, which will be held May 11-14
in Nashville. The deadline for early-bird registration ($150)
is March 12. The deadline for regular registration ($175) is
April 23.
Abstracts must be submitted online. To access submission
guidelines, go to: http://cdc.confex.com/cdc/nic2004
For general conference information, including conference goals
and objectives and registration, go to:
http://www.cdc.gov/nip/nic
For additional information, contact the conference planning team
at (404) 639-8225 or nipnic@cdc.gov
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January 12, 2004
"MASS VACCINATION CLINICS" SATELLITE BROADCAST SCHEDULED FOR
MARCH 18
From 9 am to 10:30 am PT on March 18, the California Department
of Health Services, Immunization Branch, will present the free
satellite broadcast "Mass Vaccination Clinics: A Reality Check."
Produced by California Distance Learning Health Network (CDLHN),
the broadcast is intended for health officers/directors,
bioterrorism coordinators, distance learning facilitators,
public health nurses, immunization coordinators, doctors,
medical assistants, medical assistant students, nurses, nursing
students, residents, biotechnology/pharmaceutical companies,
community services, social services, nonprofits, military
personnel, and others interested in public health.
For further information and to register, go to:
http://cdlhn.com/mvc.info
You can also call (619) 594-3348 or email
info@cdlhn.com
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January 12, 2004
WORLD VACCINE CONGRESS TO BE HELD APRIL 27-29 IN MONTREAL
The World Vaccine Congress is scheduled for April 27-29 in
Montreal. Anthony Fauci, MD, director of the National Institute
of Allergy and Infectious Diseases, National Institutes of
Health, will give the keynote presentation on April 27.
For comprehensive information about all aspects of the meeting,
go to: http://www.lifescienceworld.com/2004/wvcm_CA
For additional program information, contact Noreen Meehan by
email at noreen.meehan@terrapinn.com or by phone at
+44(0)207-827-5984.
For general information, contact Sarah Butt by email at
sarah.butt@terrapin.com or by phone at +44(0)207-827-5962.
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January 12, 2004
INTERNATIONAL AIDS CONFERENCE SCHEDULED FOR JULY 11-16
IN BANGKOK
The International AIDS Conference will be held in Bangkok
July 11-16. It is organized by the International AIDS Society
(IAS); the Thai Ministry of Public Health is the local host.
Cosponsors include the Joint United Nations Programme on
HIV/AIDS and three international community networks: the
International Community of Women Living with HIV/AIDS,
International Council of AIDS Service Organizations, and Global
Network of People Living with HIV/AIDS.
For comprehensive information about all aspects of the
conference, go to: http://www.aids2004.org
For additional information, contact the IAS in Stockholm,
Sweden, by email at aids2004@aids2004.org or by phone at
+46-8-556-970-50.
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