Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 498            December 13, 2004

CONTENTS OF THIS ISSUE

  1. DHHS announces U.S. will import 1.2 million doses of influenza vaccine from GSK manufacturing facility in Germany
  2. HAN issues an official CDC Health Update about influenza vaccine allocation
  3. Chiron announces UK regulators will extend the suspension of its license to manufacture influenza vaccine
  4. Update: CDC continues to supplement its website with information related to the influenza vaccine shortage
  5. Former Surgeon General Dr. Jocelyn Elders spearheads national hepatitis A awareness campaign
  6. New: Six states enact immunization mandates
  7. New: Migrant Clinicians Network offers comic books and videos that educate migrant parents about childhood immunization
  8. MMWR notifies readers that the Eighth Annual Conference on Vaccine Research will be held in Baltimore in May 2005
  9. New electronic update: The National Immunization Coalition TA Network is looking for subscribers
  10. 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.

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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.

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-9131

This page was updated on December 13, 2004