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Immunization Action Coalition
IAC Express 2008
Issue number 754: September 15, 2008
 
Contents of this Issue
Select a title to jump to the article.
  1. Spanish-language versions of VISs for inactivated and live influenza vaccines available on IAC website
  2. New: FDA approves expanded use of Gardasil to include preventing certain vulvar and vaginal cancers in girls and women ages 9-26
  3. IAC releases simplified version of its "After the Shots" education resource for parents
  4. IAC revises four education materials for healthcare professionals and one for patients
  5. American Public Health Association's Get Ready campaign helps communities prepare for possible emergencies, including an influenza pandemic
  6. New: Interim VIS for shingles vaccine now available in Thai
  7. MMWR publishes article about B. anthracis cross-contamination
  8. Reminder: Vaccine Education Center's Vaccine Education Symposium taking place September 27
 
Abbreviations
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.
  
Issue 754: September 15, 2008
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:

  • Vaccine safety
  • HIV vaccine development
  • Mandating influenza vaccine
  • Mandating HPV vaccine
  • The role and need for mandates
  • Influenza vaccine: Moving toward universal recommendations
  • 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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Immunization Action Coalition  •  Saint Paul, MN
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.