Issue
Number 549
September 6, 2005
CONTENTS OF THIS ISSUE
- Note: Watch for an Extra Edition of IAC Express related
to Hurricane Katrina
- FDA approves combination measles, mumps, rubella, and
varicella vaccine
- FDA approves new influenza vaccine for upcoming season
- CDC publishes updated information on influenza vaccine
supply and recommendations for prioritization
- CDC updates its website with Q&As about influenza
vaccine supply and prioritization
- FDA releases statement on Chiron Corporation inspection
- Heads up: November 4 is deadline for abstracts for the
2006 National Immunization Conference
- Updated: IAC substantially revises its
professional-education piece "Summary of Recommendations for Adult
Immunization"
- New: CDC announces addition of a
diphtheria-tetanus-pertussis module to its "You Call the Shots" training
course
- Influenza vaccination standing orders for children and
adolescents is new, standing orders for adults is updated
- Updated: Revised "Administering Vaccines to Adults:
Dose, Route, Site, Needle Size, and Preparation" now online
- Injectable typhoid vaccine currently unavailable
- 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 |
