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IAC Express 2008 |
| Issue number 754: September 15, 2008 |
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Contents
of this Issue
Select a title to jump to the article. |
-
Spanish-language versions of VISs for inactivated and live influenza
vaccines available on IAC website
- New: FDA
approves expanded use of Gardasil to include preventing certain vulvar and
vaginal cancers in girls and women ages 9-26
- IAC
releases simplified version of its "After the Shots" education resource
for parents
- IAC
revises four education materials for healthcare professionals and one for
patients
- American
Public Health Association's Get Ready campaign helps communities prepare
for possible emergencies, including an influenza pandemic
- New:
Interim VIS for shingles vaccine now available in Thai
- MMWR
publishes article about B. anthracis cross-contamination
- Reminder:
Vaccine Education Center's Vaccine Education Symposium taking place
September 27
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| Abbreviations |
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AAFP, American Academy of Family Physicians; AAP,
American Academy of Pediatrics; ACIP, Advisory Committee on Immunization
Practices; AMA, American Medical Association; CDC, Centers for Disease
Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization
Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD,
National Center for Immunization and Respiratory Diseases; NIVS, National
Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD,
vaccine-preventable disease; WHO, World Health Organization. |
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Issue 754: September 15, 2008 |
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1. |
Spanish-language versions of VISs for inactivated and live influenza vaccines
available on IAC website
Dated 7/24/08, the current versions of the VIS
for inactivated
influenza vaccine (TIV; injectable) and live influenza vaccine
(LAIV; intranasal) are now available in Spanish. IAC gratefully
acknowledges the Immunization Branch of the California
Department of Public Health for the translation.
To obtain a ready-to-print (PDF) version of the VIS for TIV in
Spanish, go to: http://www.immunize.org/vis/spflu06.pdf
To obtain a ready-to-print (PDF) version of the VIS for LAIV in
Spanish, go to: http://www.immunize.org/vis/spliveflu06.pdf
To obtain the TIV VIS in English, go to:
http://www.immunize.org/vis/2flu.pdf
To obtain the LAIV VIS in English, go to:
http://www.immunize.org/vis/liveflu.pdf
For information about the use of VISs, and for VISs in more than
35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
For general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis
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2. |
New: FDA approves expanded use of Gardasil to include preventing certain
vulvar and vaginal cancers in girls and women ages 9-26
On September 12, FDA approved the expanded use of
Gardasil in
preventing certain vulvar and vaginal cancers caused by human
papillomavirus. Also on September 12, FDA issued a press release
announcing the approval and added the approval letter and
updated package insert to its website. The press release is
reprinted below in its entirety. Links to the approval letter
and package insert appear at the end of this IAC Express
article.
FDA APPROVES EXPANDED USES FOR GARDASIL TO INCLUDE PREVENTING
CERTAIN VULVAR AND VAGINAL CANCERS
The U.S. Food and Drug Administration today announced the
approval of the vaccine Gardasil for the prevention of vaginal
and vulvar cancer caused by Human Papillomavirus (HPV) types 16
and 18 in girls and women ages 9 to 26. These two HPV types
cause 70 percent of cervical cancers, and are known to also
cause some vulvar and vaginal cancers, but the percentages are
not well defined.
"There is now strong evidence showing that this vaccine can help
prevent vulvar and vaginal cancers due to the same viruses for
which it also helps protect against cervical cancer," said Jesse
L. Goodman, MD, MPH, director of the FDA's Center for Biologics
Evaluation and Research. "While vulvar and vaginal cancers are
rare, the opportunity to help prevent them is potentially an
important additional benefit from immunization against HPV."
The FDA originally approved Gardasil in 2006 for girls and women
ages 9 to 26 for the prevention of cervical cancer caused by HPV
types 16 and 18, precancerous genital lesions caused by HPV
types 6, 11, 16, and 18 and genital warts caused by HPV types 6
and 11.
HPV includes more than 100 related viruses and more than 30
types can be transmitted via sexual contact. According to the
U.S. Centers for Disease Control and Prevention, HPV is the most
common sexually transmitted infection in the United States with
6.2 million Americans becoming infected with genital HPV each
year.
For most women, the body's own defense system will clear HPV,
thereby preventing serious health problems. However, some HPV
types can cause abnormal cell growth in areas of the cervix,
vagina, vulva, and other areas that years later may turn into
cancer.
Regarding the prevention of vulvar and vaginal cancer,
Gardasil's manufacturer, Merck & Co. Inc., followed more than
15,000 participants from the original studies for about two
additional years. Approximately half had received Gardasil as
part of the original study--the other half did not receive
Gardasil and served as a control group.
Among females who tested negative for HPV types 16 or 18 at the
start of the study, Gardasil was highly effective in preventing
these types of HPV-related precancerous vulvar and vaginal
lesions, which are considered to be the precursors for cancer.
In the control group that did not receive the vaccine, 10
individuals developed precancerous vulvar lesions and nine
developed precancerous vaginal lesions, all related to HPV types
16 or 18. No one in the Gardasil group developed either kind of
precancerous lesion due to HPV types 16 or 18.
There was no evidence for benefit among women found to have been
previously infected, prior to immunization, with the HPV types
included in the vaccine. Therefore, to receive Gardasil's full
potential for benefit, it is important to be vaccinated prior to
becoming infected with the HPV strains contained in the vaccine.
Gardasil's label has been revised to note that presently
available information is insufficient to support use beyond age
26, the current FDA-approved age. Also, new information has been
added showing that Gardasil does not protect against diseases
caused by HPV types not contained in the vaccine.
No vaccine is 100 percent effective, and Gardasil does not
protect against HPV infections that a woman may already have at
the time of vaccination. Therefore, all women should get regular
Pap tests, even after they have been vaccinated. Routine Pap
screening remains critically important to detect precancerous
changes, which would allow treatment before cancer develops.
Since the FDA approved Gardasil in 2006, the majority of
reported adverse events have not been serious. The most commonly
reported adverse events have included syncope (fainting), pain
at the injection site, headache, nausea, and fever. Fainting is
common after injections and vaccinations, especially in
adolescents. Falls after fainting may sometimes cause serious
injuries, such as head injuries, which can be prevented with
simple steps, such as keeping the vaccinated person seated for
up to 15 minutes after vaccination. This observation period is
also recommended to watch for severe allergic reactions, which
can occur after any immunization.
As part of the original approval, Merck committed to a safety
surveillance study of 44,000 individuals in a managed care
organization. The study is assessing short- and long-term safety
for all of Gardasil's approved uses.
As with all vaccines, the FDA and the CDC continue to closely
monitor Gardasil's safety. Updated safety information on
Gardasil was published on July 22 and can be found at
www.fda.gov/cber/safety/gardasil071408.htm
Product approval information for Gardasil can be found at
www.fda.gov/cber/products/gardasil.htm Merck & Co. Inc. is
located in Whitehouse Station, NJ.
To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html
To access the September 12 approval letter, go to:
http://www.fda.gov/cber/approvltr/gardasil0912208L.htm
To access the September 12 package insert, go to:
http://www.fda.gov/cber/label/gardasilLB.pdf
To access the FDA web page of resources related to Gardasil, go
to: http://www.fda.gov/cber/products/gardasil.htm
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3. |
IAC releases simplified version of its "After the Shots" education resource
for parents
IAC recently developed a simplified version of
its popular
parent education piece "After the Shots. . . What to do if your
child has discomfort."
This alternative version uses more basic English terms and
doesn't include the second page detailing possible medicines and
dosages for reducing pain and fever. Instead, a box at the
bottom of the page provides space for the healthcare provider to
write in information about contacting the office and recommended
fever- or pain-reducing medication.
To obtain a ready-to-print (PDF) version of this new resource,
go to: http://www.immunize.org/catg.d/p4014.pdf
To obtain a ready-to-print (PDF) version of the original two-page piece in English, go to:
http://www.immunize.org/catg.d/p4015.pdf
To obtain a ready-to-print (PDF) version of the original two-page piece in Spanish, go to:
http://www.immunize.org/catg.d/p4015-01.pdf
To obtain a ready-to-print (PDF) version of the original two-page piece in Japanese, go to:
http://www.immunize.org/catg.d/p4015-13.pdf
To obtain a ready-to-print (PDF) version of the original two-page piece in Turkish, go to:
http://www.immunize.org/catg.d/4015tu.pdf
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4. |
IAC revises four education materials for healthcare professionals and one for
patients
IAC recently reviewed and revised the following
the following
four print materials for healthcare professionals.
"Standing Orders for Administering Rotavirus Vaccine to Infants"
was updated to include information about the newly licensed
Rotarix vaccine.
To access the revised "Standing Orders for Administering
Rotavirus Vaccine to Infants," go to:
http://www.immunize.org/catg.d/p3087.pdf
"Give these people influenza vaccine!" was revised to take into
account the new ACIP recommendation to vaccinate all children
age 6 months through 18 years.
To access the revised "Give these people influenza vaccine," go
to: http://www.immunize.org/catg.d/p2013.pdf
"Screening Questionnaire for Intranasal Influenza Vaccination"
revised question #6 (regarding wheezing).
To access the revised "Screening Questionnaire for Intranasal
Influenza Vaccination," go to:
http://www.immunize.org/catg.d/p4067.pdf
"Screening Questionnaire for Injectable Influenza Vaccination"
had a website link updated.
To access the revised "Screening Questionnaire for Injectable
Influenza Vaccination," go to:
http://www.immunize.org/catg.d/p4066.pdf
Sarah Jane Schwarzenberg, MD, and Karen Y. Wainwright, RN, BS,
CCRA, reviewed their piece titled "You are not alone!
Information for young adults who are chronically infected with
HBV" and updated some statistics.
To access the revised "You are not alone! Information for young
adults who are chronically infected with HBV," go to:
http://www.immunize.org/catg.d/p4118.pdf
IAC's Print Materials web section has more than 175 FREE, ready-to-print English-language materials for healthcare professionals
and the public--as well as many in translation. To access all of IAC's print materials, go to:
http://www.immunize.org/printmaterials
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5. |
American Public Health Association's Get Ready campaign helps communities
prepare for possible emergencies, including an influenza pandemic
The American Public Health Association (APHA)
will host Get
Ready Day events across the nation on September 16. The day is
part of a Get Ready campaign aimed at helping Americans prepare
themselves, their families, and their communities for all
hazards, including disasters, pandemic influenza, and other
emerging infectious diseases.
To read a press release about Get Ready Day, go to:
http://www.apha.org/about/news/pressreleases/2008/GetReadyDay08.htm
To access free resources such as fact sheets about pandemic
influenza, go to: http://www.getreadyforflu.org/newsite.htm
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6. |
New: Interim VIS for shingles vaccine now available in Thai
Dated 9/11/06, the interim VIS for shingles
(zoster) vaccine is
now available in Thai. IAC gratefully acknowledges Asian Pacific
Health Care Venture of Los Angeles for the translation.
For a Thai version of the interim VIS for shingles vaccine, go
to:
http://www.immunize.org/vis/th_shingles.pdf
For an English version of the interim VIS for shingles vaccine,
go to: http://www.immunize.org/vis/shingles.pdf
For information about the use of VISs, and for VISs in more than
35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
For general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis
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7. |
MMWR publishes article about B. anthracis cross-contamination
CDC published "Cross-Contamination of Clinical
Specimens with
Bacillus anthracis During a Laboratory Proficiency Test--Idaho,
2006" in the September 12 issue of MMWR. A summary made
available to the press is reprinted below in its entirety.
In July 2006, two patient clinical samples at different hospital
laboratories were apparently cross-contaminated with the Sterne
strain of Bacillus anthracis during a proficiency testing
exercise in Idaho. The Sterne strain of B. anthracis is
relatively avirulent, posing no danger to the participating
laboratorians. However, initial reports of apparent cases of
anthrax caused concern with public health epidemiologists
unaware of the ongoing exercise, and prompted epidemiologic
investigation of both cases. Swift laboratory investigation
indicated the avirulent Sterne strain of B. anthracis, and that
the patient samples were apparently cross-contaminated during
processing. This report underscores the need to use laboratory
practices which minimize cross-contamination of specimens and
for communication with public health surveillance personnel in
the jurisdictions where laboratory proficiency testing of high-priority bioterrorism agents will take place. Vigilance for
biological threats must always be maintained.
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5736a3.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5736.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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8. |
Reminder: Vaccine Education Center's Vaccine Education Symposium taking place
September 27
The Vaccine Education Center at Children's
Hospital of
Philadelphia (CHOP) is sponsoring a one-day symposium for health
professionals on September 27. The program includes the
following topics:
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Vaccine safety
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HIV vaccine development
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Mandating influenza vaccine
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Mandating HPV vaccine
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The role and need for mandates
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Influenza vaccine: Moving toward universal recommendations
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Communicating science to the public: Lessons learned from the
vaccines and autism controversy
To access a ready-to-print (PDF) version of the symposium
brochure, go to:
http://www.chop.edu/cme/2008/vec/pdf/vaccine_cme08.pdf
To have a brochure mailed to you, phone (215) 590-5263 or fax
(215) 590-4342.
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