Issue
Number 498
December 13, 2004
CONTENTS OF THIS ISSUE
- DHHS announces U.S. will import 1.2 million doses of influenza vaccine
from GSK manufacturing facility in Germany
- HAN issues an official CDC Health Update about influenza vaccine
allocation
- Chiron announces UK regulators will extend the suspension of its
license to manufacture influenza vaccine
- Update: CDC continues to supplement its website with information
related to the influenza vaccine shortage
- Former Surgeon General Dr. Jocelyn Elders spearheads national
hepatitis A awareness campaign
- New: Six states enact immunization mandates
- New: Migrant Clinicians Network offers comic books and videos that
educate migrant parents about childhood immunization
- MMWR notifies readers that the Eighth Annual Conference on Vaccine
Research will be held in Baltimore in May 2005
- New electronic update: The National Immunization Coalition TA Network
is looking for subscribers
- GAVI and the Vaccine Fund re-launch the Immunization Forum newsletter
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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.
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December 13, 2004
DHHS ANNOUNCES U.S. WILL IMPORT 1.2 MILLION DOSES OF INFLUENZA VACCINE FROM
GSK MANUFACTURING FACILITY IN GERMANY
On December 7, the Department of Health and Human Services (DHHS) issued a
press release announcing that it purchased 1.2 million doses of influenza
vaccine from a GlaxoSmithKline (GSK) manufacturing facility in Germany.
Portions of the press release are reprinted below.
********************
For immediate release
December 7, 2004
HHS PURCHASES 1.2 MILLION DOSES OF FLU VACCINE: GlaxoSmithKline Vaccine Adds
To 61 Million Doses In United States
HHS Secretary Tommy G. Thompson announced today that the Food and Drug
Administration authorized the use of GlaxoSmithKline influenza vaccine,
Fluarix, in the United States under an Investigational New Drug application.
Additionally, HHS has reached an agreement with the company to purchase 1.2
million doses of the vaccine for distribution to areas most in need.
This purchase is part of the Department's ongoing effort to identify and
make available additional influenza vaccine doses to protect the American
public for this winter's flu season. The doses of Fluarix vaccine are in
addition to the existing supply of 61 million doses of licensed influenza
vaccine, which includes about 58 million doses of Aventis injectable vaccine
and 3 million doses of FluMist nasal spray. . . .
Beginning this week, the Fluarix vaccine will be sent to the United States
for distribution by the Centers for Disease Control and Prevention (CDC),
based on the agency's determination of communities most in need. Fluarix has
not been licensed for use in the United States and will be administered
under an Investigational New Drug application (IND). The Fluarix vaccine
being purchased by HHS has been approved by the European equivalents of the
Food and Drug Administration (FDA), but is considered an IND because it is
not currently licensed by FDA. The IND allows the investigational use of
Fluarix, and HHS is immediately purchasing 1.2 million doses that are
available this month. GlaxoSmithKline (GSK) has agreed to make up to 4
million doses available under the IND.
Under an IND, patients who are offered the Fluarix vaccine must sign an
informed consent form that provides important information and acknowledges
that they are aware of the potential adverse effects associated with the
investigational vaccine. Sponsors of INDs are required to monitor the use of
the investigational product, maintain adequate records, control the supply
of product, provide periodic reports to FDA regarding safety and other
issues and make sure informed consent is obtained from individuals before
receiving the vaccine. CDC will assist GSK with these activities.
FDA has, over the past month, reviewed extensive manufacturing and clinical
information and conducted an inspection of the GSK manufacturing facility in
Germany to determine that this vaccine is suitable for use under an IND. FDA
reviewed GSK's proposed clinical study plan and informed consent document,
as well as the clinical protocol and manufacturing data. The IND mechanism
can be used in this situation because there is not enough time or
information to allow U.S. licensure. These steps along with the conditions
and controls required under the IND are designed to assure the product is
safe for use during the current flu season. . . .
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To access the entire press release, go to:
http://www.dhhs.gov/news/press/2004pres/20041207.html
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December 13, 2004
HAN ISSUES AN OFFICIAL CDC HEALTH UPDATE ABOUT INFLUENZA VACCINE ALLOCATION
On December 8, the Health Alert Network (HAN) issued an Official CDC Health
Update about influenza vaccine allocation. It is reprinted below in its
entirety.
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This is an Official CDC Health Update
Distributed via Health Alert Network
December 8, 2004, 12:48PM ET
UPDATE ON FLU VACCINE ALLOCATION
CDC continues to work with state and local health officials to make vaccine
available to high-risk individuals as designated by the Advisory Committee
on Immunization Practices (ACIP). However, CDC is aware that geographic
differences in vaccine distribution and demand remain across the nation.
Some areas may have small amounts of vaccine scattered among private sector
providers that would be difficult to redistribute. To ensure that no vaccine
is lost or wasted, if a State Health Official determines that members of the
state's high-priority populations desiring to be immunized have indeed
received vaccine, and additional vaccine is currently available on-hand in
the private sector, the state may choose to recommend a limited expansion of
eligibility for immunization with those existing private sector doses. Such
an expansion might include individuals who would normally receive vaccine
such as those between 50 and 65 years of age, household contacts of
high-priority individuals, or other populations deemed to be at risk by the
state. However, even if such a recommendation is made, private providers
with a large volume of unused vaccine on hand should be encouraged, wherever
practical, to work with the state to transfer such doses to other states
with unmet high-priority needs.
Furthermore, until such time as all ACIP-designated high-priority
individuals in all states have had the opportunity to be immunized, vaccine
currently held in the public sector and apportioned vaccine that has not yet
been delivered should continue to be directed only to these high-priority
populations. All vaccine that has not yet been delivered should be made
available only to those states with unmet demand among the priority groups.
CDC will conduct a second re-allocation to facilitate this availability.
As CDC has done since the influenza vaccine shortage was announced in early
October, it will continue to work with the Association of State and
Territorial Health Officials (ASTHO) to assess the vaccine supply situation
to ensure that all high-priority individuals wishing to receive vaccine have
the opportunity to do so. If subsequent additional adjustments in
distribution appear warranted, they will be made at that time.
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To access the health update, go to:
http://www.phppo.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00218
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December 13, 2004
CHIRON ANNOUNCES UK REGULATORS WILL EXTEND THE SUSPENSION OF ITS LICENSE TO
MANUFACTURE INFLUENZA VACCINE
On December 7, Chiron Corporation, Emeryville, CA, issued a press release
announcing that UK regulators will extend the suspension of its license to
manufacture influenza vaccine. Portions of the press release are reprinted
below.
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MHRA NOTIFIES CHIRON OF CONTINUING SUSPENSION OF LIVERPOOL LICENSE FOR
INFLUENZA VACCINES; Suspension May Be Lifted If Compliance with License
Demonstrated
Chiron Corporation today announced that it has received notice from the UK
Medicines and Healthcare Products Regulatory Agency (MHRA) that the MHRA
proposes to continue the suspension of the company's license to manufacture
influenza vaccines in Liverpool for a further period of three months,
effective January 4, 2005, at the same time as the expiration of the initial
three-month suspension.
A spokesperson for the UK Department of Health stated that the extension of
the suspension "does not result from any newly identified safety issues or
findings at the Liverpool plant" and called it "routine regulatory action"
that will give Chiron more time to carry out its remediation plan, which is
currently underway. The spokesperson also stated that the suspension could
be lifted at any time upon satisfactory compliance with the facility's
license. The MHRA has worked closely with the U.S. Food and Drug
Administration on these issues, and the agencies plan to examine progress at
the facility throughout the remediation process.
In order to meet timelines for delivery of Fluvirin influenza virus vaccine
for the U.S. market, production must begin no later than early spring of
2005. The MHRA notice fulfills an agency requirement to allow Chiron a
28-day period to appeal the notice. Chiron does not intend to pursue this
option. . . .
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To access the entire press release, go to:
http://www.chiron.com/investors/pressreleases/press_release120704.html
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December 13, 2004
UPDATE: CDC CONTINUES TO SUPPLEMENT ITS WEBSITE WITH INFORMATION RELATED TO
THE INFLUENZA VACCINE SHORTAGE
CDC recently updated its Influenza web section, adding one new fact sheet,
creating a web page of influenza information for businesses and the
workplace, revising a guideline, and making a revised patient-screening form
available in four additional languages. Following are descriptions of and
links to these documents.
(1) The new two-page "Fact Sheet: Protecting Against the Flu: Advice for
Caregivers of Children Less Than 6 Months Old" outlines strategies
caregivers can use to protect themselves from getting influenza, and if they
get it, to keep from spreading it to vulnerable infants.
To access a ready-to-print (PDF) version of the fact sheet, go to:
http://www.cdc.gov/flu/protect/pdf/infantcare.pdf
To access a web-text (HTML) version of it, go to:
http://www.cdc.gov/flu/protect/infantcare.htm
(2) The new web page "Businesses and the Workplace" consolidates CDC's
information about preventing colds and influenza at worksites. It features a
list of useful suggestions, as well as numerous links to pertinent
resources. To access the new web page, go to:
http://www.cdc.gov/flu/workplace
(3) Intended for clinicians and public health officials, the two-page
"Guidelines and Recommendations: Guidance for Prevention and Control of
Influenza in the Peri- and Postpartum Settings" was revised on December 8.
To access a ready-to-print (PDF) version of the revised guideline, go to:
http://www.cdc.gov/flu/professionals/infectioncontrol/pdf/peri-post-settings.pdf
To access a web-text (HTML) version of it, go to:
http://www.cdc.gov/flu/professionals/infectioncontrol/peri-post-settings.htm
(4) On November 30, the one-page "Patient Screening Form for Health Care
Providers Offering FluMist Live Attenuated Intranasal Influenza Vaccine
during the 2004-05 Flu Season" was revised. The revised version is now
available in Spanish, Chinese, Tagalog, and Vietnamese, in addition to
English.
To access a ready-to-print (PDF) version of the revised screening form in
SPANISH, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform-spa.pdf
To access a ready-to-print (PDF) version of it CHINESE, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform-chi.pdf
To access a ready-to-print (PDF) version of it TAGALOG, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform-tag.pdf
To access a ready-to-print (PDF) version of it VIETNAMESE, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform-vie.pdf
To access a ready-to-print (PDF) version of it ENGLISH, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform.pdf
For ongoing information about new and updated additions to CDC's Influenza
web section, go to:
http://www.cdc.gov/flu/whatsnew.htm
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December 13, 2004
FORMER SURGEON GENERAL DR. JOCELYN ELDERS SPEARHEADS NATIONAL HEPATITIS A
AWARENESS CAMPAIGN
In association with the National Partnership for Immunization (NPI), Former
Surgeon General Dr. Jocelyn Elders is leading "This 'A' Can Spell Danger to
Your Child," a national hepatitis A awareness campaign. The timing of the
campaign coincides with the one-year anniversary of the largest hepatitis A
outbreak in U.S. history. The outbreak occurred when green onions
contaminated with the hepatitis A virus sickened 600 people in Pittsburgh,
leading to the deaths of three.
The hepatitis A vaccine provides protection against the disease, which
infects almost 100,000 Americans each year. Expanding the childhood
immunization requirements for hepatitis A could reduce the incidence of the
disease.
For further information about the campaign, go to:
http://www.partnersforimmunization.org/spelldanger.html
For links to information about hepatitis A disease and vaccine, go to:
http://www.partnersforimmunization.org/hepatitisa.html
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December 13, 2004
NEW: SIX STATES ENACT IMMUNIZATION MANDATES
Arkansas, Missouri, and New York enacted legislation regarding varicella
vaccination for elementary and middle school students. Connecticut enacted
legislation regarding hepatitis B vaccination for college students, and
Massachusetts now has laws regarding meningococcal vaccination for college
students. Pennsylvania now requires hospitals to offer patients influenza
and pneumococcal vaccinations.
VARICELLA IMMUNIZATION
Arkansas: On July 22, the Arkansas State Board of Health approved a
regulation requiring varicella vaccination (or history of disease) for
seventh-grade students. Effective September 1, 2004, the regulation extends
the current varicella vaccination requirements, which previously had applied
only to kindergarten students.
Missouri: The Missouri Department of Health and Senior Services enacted a
rule on April 30, 2004. It will require varicella vaccination (or proof of
disease) for children entering kindergarten, beginning with the 2005-06
school year.
New York: A bill signed by the governor on September 14 will require
varicella vaccination (or proof of disease) for sixth-grade students born on
or after January 1, 1994. The law will become effective January 1, 2005. It
extends the state's current varicella requirements, which now apply only to
students born on or after January 1, 1998.
IAC has compiled information about states that have varicella prevention
mandates for school attendance. To access this information, go to:
http://www.immunize.org/laws/varicel.htm
For a visual depiction of this information on a U.S. map, go to:
http://www.immunize.org/laws/varimap.pdf
HEPATITIS B IMMUNIZATION
Connecticut: The governor signed a bill on June 6 that requires public and
independent colleges and universities to provide all matriculated students
with information about hepatitis B disease and vaccine. It will become
effective in fall 2005.
IAC has compiled information about states that have hepatitis B prevention
mandates for college and university attendance. To access this information,
go to:
http://www.immunize.org/laws/hepbcollege.htm
For a visual depiction of this information on a U.S. map, go to:
http://www.immunize.org/laws/hepbcolmap.pdf
MENINGOCOCCAL IMMUNIZATION
Massachusetts: The governor signed a bill on July 30 that requires all
full-time and part-time students who are initial enrollees at colleges with
on-campus housing to be vaccinated against meningococcal disease at least
two weeks prior to residency. The new requirement, which becomes effective
in September 2005, allows for medical exemptions and waivers for students
who have received the information and choose not to be vaccinated. The
department of health must promulgate rules and regulations for enforcement.
IAC has compiled information about states that have meningococcal disease
prevention mandates for college and university attendance. To access this
information, go to:
http://www.immunize.org/laws/menin.htm
For a visual depiction of this information on a U.S. map, go to:
http://www.immunize.org/laws/meninmap.pdf
INFLUENZA AND PNEUMOCOCCAL IMMUNIZATION
Pennsylvania: The governor approved legislation on July 15 that requires
hospitals to offer influenza vaccination (during October and November) and
pneumococcal vaccination to patients who are admitted for more than 24 hours
for a condition not related to either disease. The law became effective on
October 13.
For complete and current information about state mandates for a variety of
immunizations, go to:
http://www.immunize.org/laws
We depend on our readers to help us stay informed and to ensure
our website contains the most current and accurate information
available. Please let us know when any changes occur in your
state.
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December 13, 2004
NEW: MIGRANT CLINICIANS NETWORK OFFERS COMIC BOOKS AND VIDEOS
THAT EDUCATE MIGRANT PARENTS ABOUT CHILDHOOD IMMUNIZATION
Through its Migrant Immunization Initiative, the Migrant
Clinician's Network (MCN) now offers the "Adventures of Pepin,"
a series of videos, DVDs, and comic books that are the pictorial
equivalents of Vaccine Information Statements. A cartoon
character developed by Texas Tech University Health Science
Center at ElPaso, Pepin provides information about childhood
vaccination in Spanish and English.
Videos and DVDs are available for the following vaccines: DTaP,
MMR, polio, hepatitis A, hepatitis B, varicella, PCV, and Hib.
Comic books are available for DTaP, MMR, hepatitis B, and
varicella vaccines. All items are free with a nominal shipping
and handling fee. Supplies are limited, and orders will be
filled on a first-come first-serve basis through April 15, 2005.
To access an online ordering form, go to:
http://www.migrantclinician.org/excellence/otherpages/pepin_orderform.php
To order by mail or fax, request an order form by calling MCN at
(512) 327-2017 or by emailing Lisa Black at
lblack@migrantclinician.org or Amy Liebman at
aliebman@migrantclinician.org
Founded in 1984, MCN offers support, technical assistance, and
professional development services to clinicians working in
migrant health. To learn more about MCN, go to:
http://www.migrantclinician.org
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December 13, 2004
MMWR NOTIFIES READERS THAT THE EIGHTH ANNUAL CONFERENCE ON
VACCINE RESEARCH WILL BE HELD IN BALTIMORE IN MAY 2005
CDC published "Notice to Readers: Eighth Annual Conference on
Vaccine Research" in the December 10 issue of MMWR. The notice
is reprinted below in its entirety.
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The Eighth Annual Conference on Vaccine Research will be held
May 9-11, 2005, in Baltimore, Maryland. The largest scientific
conference devoted exclusively to vaccinology, it features both
submitted abstracts and invited presentations across many
disciplines to encourage the exchange of ideas and approaches
for immunization against diverse human and veterinary pathogens
and conditions. The conference is cosponsored by CDC, the
National Foundation for Infectious Diseases (NFID), and 10 other
national and international agencies, institutes, and
organizations.
A new travel grants program, sponsored by the Bill and Melinda
Gates Foundation, offers financial support to researchers in
resource-limited countries to present their work at the
conference. Deadline for submission of application and
associated abstracts for travel grants is January 3, 2005.
Conference attendees can register online now. Deadline for
online submission of abstracts for oral and poster presentations
is February 7, 2005. Program announcements and information on
abstract submission, registration, hotel reservation, and travel
grant application are available at
http://www.nfid.org/conferences/vaccine05; from NFID, Suite 750,
4733 Bethesda Avenue, Bethesda, MD 20814-5278; telephone
(301) 656-0003, ext. 19; fax (301) 907-0878; or email
vaccine@nfid.org
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To access a web-text (HTML) version of the notice, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5348a5.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5348.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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December 13, 2004
NEW ELECTRONIC UPDATE: THE NATIONAL IMMUNIZATION COALITION TA
NETWORK IS LOOKING FOR SUBSCRIBERS
The National Immunization Coalition TA [Technical Assistance]
Network produces an electronic update of helpful resources for
immunization coalitions and would-be coalitions. As an example,
the December 1 update directs readers to information about
organizing a coalition, increasing community immunization rates,
and participating in a teleconference on immunization advocacy.
A program of the Academy for Educational Development, the
network receives funding from CDC's National Immunization
Program.
To subscribe to the update, send an email with SUBSCRIBE in the
subject or body of the email to Katherine Shrout at
kshrout@aed.org
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December 13, 2004
GAVI AND THE VACCINE FUND RE-LAUNCH THE IMMUNIZATION FORUM
NEWSLETTER
The Global Alliance for Vaccines & Immunization (GAVI) and The
Vaccine Fund are jointly publishing the Immunization Forum
newsletter. Dated November 2004, the first issue of the joint
publishing venture is available in English and French. Click
here to view the issue. |
