Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 549            September 6, 2005

CONTENTS OF THIS ISSUE

  1. Note: Watch for an Extra Edition of IAC Express related to Hurricane Katrina
  2. FDA approves combination measles, mumps, rubella, and varicella vaccine
  3. FDA approves new influenza vaccine for upcoming season
  4. CDC publishes updated information on influenza vaccine supply and recommendations for prioritization
  5. CDC updates its website with Q&As about influenza vaccine supply and prioritization
  6. FDA releases statement on Chiron Corporation inspection
  7. Heads up: November 4 is deadline for abstracts for the 2006 National Immunization Conference
  8. Updated: IAC substantially revises its professional-education piece "Summary of Recommendations for Adult Immunization"
  9. New: CDC announces addition of a diphtheria-tetanus-pertussis module to its "You Call the Shots" training course
  10. Influenza vaccination standing orders for children and adolescents is new, standing orders for adults is updated
  11. Updated: Revised "Administering Vaccines to Adults: Dose, Route, Site, Needle Size, and Preparation" now online
  12. Injectable typhoid vaccine currently unavailable
  13. New: Draft agenda for the National Viral Hepatitis Prevention Conference now available

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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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September 6, 2005
NOTE: WATCH FOR AN EXTRA EDITION OF IAC EXPRESS RELATED TO HURRICANE KATRINA

Later today, IAC will publish an Extra Edition of IAC Express with immunization recommendations related to Hurricane Katrina. The issue will include interim recommendations from CDC for the immunization of emergency workers and displaced persons.
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September 6, 2005
FDA APPROVES COMBINATION MEASLES, MUMPS, RUBELLA, AND VARICELLA VACCINE

On September 6, the Federal Drug Administration (FDA) approved Merck's ProQuad, a live vaccine indicated for vaccination against measles, mumps, rubella, and varicella in children ages 12 months to 12 years.

To read the FDA approval information, go to:
http://www.fda.gov/cber/products/mmrvmer090605.htm

To read the package insert, go to:
http://www.fda.gov/cber/label/mmrvmer090605LB.pdf
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September 6, 2005
FDA APPROVES NEW INFLUENZA VACCINE FOR UPCOMING SEASON

On August 31, the Federal Drug Administration (FDA) approved GlaxoSmithKline's Fluarix, a trivalent inactivated influenza vaccine for adults. Fluarix is approved to immunize adults age 18 and older against influenza virus types A and B contained in the vaccine.

To read the FDA press release, go to:
http://www.fda.gov/bbs/topics/news/2005/NEW01227.html

To read the package insert, go to:
http://www.fda.gov/cber/label/inflgla083105LB.pdf
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September 6, 2005
CDC PUBLISHES UPDATED INFORMATION ON INFLUENZA VACCINE SUPPLY AND RECOMMENDATIONS FOR PRIORITIZATION

CDC published "Update: Influenza Vaccine Supply and Recommendations for Prioritization During the 2005–06 Influenza Season" in the September 2 issue of MMWR. The article is reprinted below in its entirety with the exception of footnotes and one table, "Influenza vaccine manufacturers and projected supplies for the 2005–06 influenza season."

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Influenza vaccine distribution delays or vaccine supply shortages have occurred in the United States in three of the last five influenza seasons. In response, prioritization has been implemented in previous years to ensure that enough vaccine is available for those at the highest risk for complications from influenza. The information in this report updates projections of influenza vaccine supply and previous recommendations for priority use of trivalent inactivated influenza vaccine (TIV) during the 2005–06 influenza season.

Four manufacturers now expect to provide influenza vaccine to the U.S. population during the 2005–06 influenza season. Sanofi Pasteur, Inc., projects production of 60 million doses of TIV. Chiron Corporation projects production of 18–26 million doses of TIV. GlaxoSmithKline (GSK), Inc., whose license application was approved by the Food and Drug Administration on August 31, 2005, projects production of 8 million doses of TIV. MedImmune Vaccines, Inc., producer of live attenuated influenza vaccine (LAIV), projects production of approximately 3 million doses. However, because of the uncertainties regarding production of influenza vaccine, the exact number of available doses and timing of vaccine distribution for the 2005–06 influenza season remain unknown.

Given the uncertainties in doses and distribution, CDC recommends that the following priority groups receive TIV until October 24, 2005:

  • persons aged >=65 years with comorbid conditions
  • residents of long-term–care facilities
  • persons aged 2–64 years with comorbid conditions
  • persons aged >=65 years without comorbid conditions
  • children aged 6–23 months
  • pregnant women
  • health-care personnel who provide direct patient care
  • household contacts and out-of-home caregivers of children aged <6 months

These groups correspond to tiers 1A–1C in the table of TIV priority groups that was published previously in the event of vaccination supply disruption. Beginning October 24, 2005, all persons will be eligible for vaccination.

The tiered use of prioritization is not recommended for LAIV administration. LAIV may be administered at any time for vaccination of nonpregnant healthy persons aged 5–49 years, including most health-care personnel, other persons in close contact with groups at high risk for influenza-related complications, and others desiring protection against influenza. Additional information is available at http://www.cdc.gov/flu

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To access a web-text (HTML) version of the article, which includes the table "Influenza vaccine manufacturers and projected supplies for the 2005–06 influenza season," go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5434a4.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5434.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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September 6, 2005
CDC UPDATES ITS WEBSITE WITH Q&As ABOUT INFLUENZA VACCINE SUPPLY AND PRIORITIZATION

CDC recently updated its Influenza web page with a Q&A section about vaccine supply and prioritization. To access this information, go to: http://www.cdc.gov/flu/about/qa/0506supply.htm
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September 6, 2005
FDA RELEASES STATEMENT ON CHIRON CORPORATION INSPECTION

On August 31, the Federal Drug Administration (FDA) released the following statement on the Chiron Corporation inspection.

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"We are pleased that the Chiron Corporation has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season," said Dr. Jesse Goodman, FDA Director of the Center for Biologics Evaluation and Research. "The letter that we issued to them this week is a positive development and shows significant progress on their part. However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S."

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To access this statement on the FDA website, go to:
http://www.fda.gov/bbs/topics/news/2005/NEW01226.html
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September 6, 2005
HEADS UP: NOVEMBER 4 IS DEADLINE FOR ABSTRACTS FOR THE 2006 NATIONAL IMMUNIZATION CONFERENCE

November 4 is the deadline for submitting abstracts for CDC's 2006 National Immunization Conference, which will be held in Atlanta, GA, on March 6-9, 2006. Abstracts must be submitted online. To access submission guidelines, go to: http://www.cdc.gov/nip/nic/#abstract

The deadline for early-bird registration ($175) is January 13. The deadline for regular registration ($200) is February 17. Late and on-site registration will be $225.

For general information on the 40th National Immunization Conference, including conference goals, objectives, and registration, go to: http://www.cdc.gov/nip/nic

Those without Internet access can contact the conference planning team at (404) 639-8225 or nipnic@cdc.gov
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September 6, 2005
UPDATED: IAC SUBSTANTIALLY REVISES ITS PROFESSIONAL-EDUCATION PIECE "SUMMARY OF RECOMMENDATIONS FOR ADULT IMMUNIZATION"

If you see adult patients in your practice or another immunization setting, it's imperative that you download and print IAC's newly revised "Summary of Adult Immunization Recommendations." The adult summary distills hundreds of pages of ACIP recommendations for adult immunization into a handy document that can be printed on card stock and placed in every exam room for easy reference.

The summary was updated in August 2005 to reflect new ACIP recommendations on many vaccines. To accommodate all this new information, and to make this resource easier to read, the document has been expanded to three pages. Immunization experts at CDC have reviewed the information in the document for technical accuracy.

To obtain the document in ready-to-print (PDF) format, go to:
http://www.immunize.org/catg.d/p2011b.pdf

To obtain it in web-text (HTML) format, go to:
http://www.immunize.org/catg.d/p2011b.htm
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September 6, 2005
NEW: CDC ANNOUNCES ADDITION OF A DIPHTHERIA-TETANUS-PERTUSSIS MODULE TO ITS "YOU CALL THE SHOTS" TRAINING COURSE

CDC's National Immunization program (NIP) recently announced the addition of a diphtheria-tetanus-pertussis module to its web-based training course "Immunization: You Call the Shots." This module includes descriptions of diphtheria, tetanus, and pertussis; information on the vaccines to protect against these diseases; and recommendations for vaccine use. Extra learning opportunities, self-test practice questions, reference and resource materials, and a glossary are all provided.

This module does not include a discussion of the new Tdap vaccines for adolescents and adults. Information on these vaccines will be included at a later date, after publication of Tdap recommendations by ACIP.

For additional information on "You Call the Shots," go to:
http://www.cdc.gov/nip/ed/youcalltheshots.htm

To access the module "Diphtheria, Tetanus, Pertussis," go to:
http://www2.cdc.gov/nip/isd/ycts/mod1/courses/dtp/start.asp
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September 6, 2005
INFLUENZA VACCINATION STANDING ORDERS FOR CHILDREN AND ADOLESCENTS IS NEW, STANDING ORDERS FOR ADULTS IS UPDATED

In response to many requests, IAC has developed a standing orders protocol for administering influenza vaccines to children and adolescents. Intended to help increase immunization rates, standing orders protocols are guidelines health professionals can use to allow appropriately licensed individuals to administer vaccines without a physician's direct order.

To access a ready-to-print (PDF) version of "Standing Orders for Administering Influenza Vaccines to Children & Adolescents," go
to: http://www.immunize.org/catg.d/p3074a.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/p3074a.htm

IAC has also updated its "Standing Orders for Administering Influenza Vaccine to Adults."

To access a ready-to-print (PDF) version of it, go to:
http://www.immunize.org/catg.d/p3074.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/p3074.htm

Note: Using the HTML format, providers can cut, paste, and modify these protocols to create ones that meet the needs of their practice or clinic.
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September 6, 2005
UPDATED: REVISED "ADMINISTERING VACCINES TO ADULTS: DOSE, ROUTE, SITE, NEEDLE SIZE, AND PREPARATION" NOW ONLINE

IAC recently updated its professional-education piece "Administering Vaccines to Adults: Dose, Route, Site, Needle Size, and Preparation."

To access a ready-to-print (PDF) version of it, go to:
http://www.immunize.org/catg.d/p3084.pdf

Note: No HTML version is available.
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September 6, 2005
INJECTABLE TYPHOID VACCINE CURRENTLY UNAVAILABLE

The manufacturer of injectable typhoid vaccine has reported the vaccine is currently unavailable. The notice is reprinted below.

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The manufacturer of injectable typhoid vaccine, (Typhim Vi),* has reported the vaccine is currently unavailable. No anticipated date of availability for this product has been established. A live, oral vaccine (Vivotif Berna)*, also known as Ty21a, remains available for most travelers.

Because both typhoid vaccines protect 50%–80% of recipients, careful selection of food and drink and attention to hygiene are also necessary to reduce the risk of typhoid infection. Such precautions will protect the traveler against typhoid fever as well as other common travel-related illnesses, including traveler's diarrhea.

For more information about typhoid fever and typhoid vaccines, see
http://www.cdc.gov/ncidod/dbmd/diseaseinfo/typhoidfever_g.htm

*Typhim Vi is produced by Sanofi-Pasteur MSD and Vivotif Berna is produced by Berna Products, Corp.

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To read this announcement on CDC's website, go to:
http://www.cdc.gov/travel/other/typhim_vi_unavailable_2005.htm
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September 6, 2005
NEW: DRAFT AGENDA FOR THE NATIONAL VIRAL HEPATITIS PREVENTION CONFERENCE NOW AVAILABLE

A draft agenda for the National Viral Hepatitis Prevention Conference is now available online at http://www.signup4.net/Public/ap.aspx?EID=2004101E&OID=110

The conference will be held December 5–9 in Washington, DC. For more information, visit the conference website at http://www.nvhpc.com

 

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 September 6, 2005