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Immunization Action Coalition
IAC Express 2009
Issue number 828: October 19, 2009
Please click here to subscribe to IAC Express as well as other FREE IAC periodicals.
Contents of this Issue
Select a title to jump to the article.
  1. FDA approves new vaccine, Cervarix, for prevention of cervical cancer caused by HPV types 16 and 18
  2. FDA approves new indication for the use of Gardasil to prevent genital warts in boys and men
  3. CDC issues Health Advisory counseling clinicians to initiate antiviral treatment in patients with suspected influenza who are at increased risk of developing severe disease
  4. Seasonal influenza vaccine pocket guides--FREE!--from the National Influenza Vaccine Summit
  5. Eleven more organizations that mandate influenza vaccination of healthcare workers join IAC's Honor Roll for Patient Safety
  6. Important: During H1N1 influenza outbreak, administer PPSV to all people with existing indications
  7. CDC updates its H1N1 web section with information on infection control and more
  8. Keep vaccinating against seasonal influenza!
  9. FDA warns consumers about unapproved and illegal H1N1 drug products purchased over the Internet
  10. Book about families and individuals devastated by vaccine-preventable diseases is a must for every waiting room
  11. IAC's Video of the Week features Sesame Street's Elmo demonstrating easy ways to stay healthy
  12. VISs for 2009 H1N1 influenza vaccines available in up to 10 additional languages
  13. VISs for seasonal influenza vaccines available in Hmong, Karen, Russian, and Somali
  14. IAC's padded screening questionnaires for contraindications now have English on front, Spanish on back--a popular translation at no added cost!
  15. CDC's Pre-teen Vaccine Campaign now has materials for Native American, Korean, and Vietnamese audiences
  16. CDC's 2010 National Immunization Conference set for April 19-22 in Atlanta; abstracts due December 11
  17. Summary report from the June 2009 ACIP meeting now online
 
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 828: October 19, 2009
1.  FDA approves new vaccine, Cervarix, for prevention of cervical cancer caused by HPV types 16 and 18

On October 16, FDA issued a press release announcing that it has approved Cervarix (GlaxoSmithKline) for use in girls and women ages 10 through 25 years to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The press release is reprinted below in its entirety. Links to the approval letter and the package insert are given at the end of this IAC Express article.


The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

Genital HPV infections are the most common sexually-transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide. There will be an estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States during 2009, according to the National Cancer Institute at the National Institutes of Health.

"The licensure of Cervarix adds another option in the prevention of cervical cancer" said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research. "It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests."

The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

The results showed that among women who had not already been infected by HPV types 16 and/or 18 before the start of the study, Cervarix was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types. Among all Cervarix vaccinees, which included those who tested negative for HPV 16 and/or 18, and those who tested positive at the start of the study, Cervarix was approximately 53 percent effective in preventing precancerous cervical lesions.

Studies also were performed to measure the immune response to Cervarix in girls ages 10 years through 14 years. Their immune response was similar to that of women ages 15 years through 25 years, indicating that the vaccine should have similar effectiveness in the 10 through 14 year age group.

The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.

No vaccine is 100 percent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine. Therefore, regular Pap tests continue to be recommended for all women who receive Cervarix. Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Cervarix contains the adjuvant ASO4. ASO4 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL) and is the first vaccine licensed by the FDA that includes MPL as an adjuvant. An adjuvant is a substance incorporated into a vaccine that enhances or directs the immune response of the vaccinated individual.

The safety of the vaccine was evaluated in about 24,000 girls and women, with about 13,000 of these receiving Cervarix. The most commonly reported adverse reactions in the Cervarix group included pain, redness, and swelling at the injection site, fatigue, headache, muscle and joint aches, and gastrointestinal distress.

Although Cervarix is not indicated for pregnant women, the FDA is requiring the manufacturer, GlaxoSmithKline Biologicals to conduct a postmarketing study to assess the safety of Cervarix in pregnant women following vaccination prior to identification of pregnancy. Women who are pregnant, or think that they may be pregnant, or plan to become pregnant during the vaccination course, should not use Cervarix.

Cervarix is administered in three separate shots, with the initial dose being followed by two additional shots at one and six months.

Cervarix is manufactured by GlaxoSmithKline Biologicals, based in the United Kingdom.


To access the press release, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm

To access the product approval letter, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186959.htm

To access the package insert, go to:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf

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2 FDA approves new indication for the use of Gardasil to prevent genital warts in boys and men

On October 16, FDA issued a press release announcing that it has approved the use of the human papillomavirus (HPV) vaccine Gardasil (Merck) for the prevention of genital warts in boys and men 9 through 26 years. The press release is reprinted below in its entirety. Links to the approval letter and the package insert are given at the end of this IAC Express article.


The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

"This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research.

Gardasil's effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever, and pain at the injection site, itching, redness, swelling, and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, NJ.

Gardasil product information:
www.fda.gov/cber/products/gardasil.htm


To access the press release, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm

To access the product approval letter, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186991.htm

To access the package insert, go to:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf

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3 CDC issues Health Advisory counseling clinicians to initiate antiviral treatment in patients with suspected influenza who are at increased risk of developing severe disease

On October 19, CDC issued an official Health Advisory. It is reprinted below in its entirety.


Recommendations for Early Empiric Antiviral Treatment in Persons with Suspected Influenza who are at Increased Risk of Developing Severe Disease

Summary Recommendations: When treatment of influenza is indicated in a patient with suspected influenza, healthcare providers should initiate empiric antiviral treatment as soon as possible. Waiting for laboratory confirmation of influenza to begin treatment with antiviral drugs is not necessary. Patients with a negative rapid influenza diagnostic test should be considered for treatment if clinically indicated because a negative rapid influenza test result does not rule out influenza virus infection. The sensitivity of rapid influenza diagnostic tests for 2009 H1N1 virus can range from 10% to 70%, indicating that false negative results occur frequently.

Situation

The 2009 pandemic H1N1 influenza virus continues to be the dominant influenza virus in circulation in the U.S. The benefit of antiviral treatment is greatest when it is initiated as early as possible in the clinical course. Several recent reports have indicated two problems related to antiviral treatment: (1) some patients with suspected influenza who are at higher risk of developing severe complications, including hospitalized patients, were not treated at all with antiviral medications because of a negative rapid influenza diagnostic test result and (2) initiation of treatment was delayed for some patients with suspected influenza who are at higher risk of developing severe complications, including hospitalized patients, because clinicians were waiting for results of real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) assay.

Who is prioritized for treatment with influenza antiviral drugs?

Most healthy persons (i.e., those without a condition that puts them at higher risk for complications) who develop an illness consistent with uncomplicated influenza do not need to be treated with antiviral medications and will recover without complications. However, clinical judgment should be the ultimate guide in making antiviral treatment decisions for ill persons who are not at higher risk for complications from influenza.

Early empiric treatment with oseltamivir or zanamivir is recommended for all persons with suspected or confirmed influenza requiring hospitalization. Prompt empiric outpatient antiviral therapy is also recommended for persons with suspected influenza who have symptoms of lower respiratory tract illness or clinical deterioration regardless of previous health or age.

Early empiric treatment should be considered for persons with suspected or confirmed influenza who are at higher risk for complications, even if not hospitalized, including:
  • Children younger than 2 years old
  • Adults 65 years and older
  • Pregnant women
  • Persons with the following conditions:
    • Chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological  (including sickle cell disease), or metabolic disorders (including diabetes mellitus);
    • Disorders that that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, or other neuromuscular disorders)
    • Immunosuppression, including that caused by medications or by HIV;
    • Persons younger than 19 years of age who are receiving long-term aspirin therapy, because of an increased risk for Reye syndrome.

When should healthcare providers start treatment with antiviral drugs?

Once the decision to administer antiviral treatment is made, oseltamivir or zanamivir should be initiated as soon as possible. Evidence for benefit from antiviral treatment in studies of seasonal influenza is strongest when treatment is started within 48 hours of illness onset. However, some studies of oseltamivir treatment of hospitalized patients with seasonal influenza have indicated benefit, including reductions in mortality or duration of hospitalization, even for patients whose treatment was started more than 48 hours after illness onset.

When treatment is indicated, healthcare providers should not wait for laboratory confirmation of influenza to begin oseltamivir or zanamivir treatment of patients with suspected 2009 pandemic H1N1 influenza virus infection. Patients with a negative rapid influenza diagnostic test should be considered for treatment if clinically indicated because a negative result does not rule out influenza virus infection. The sensitivity of rapid influenza diagnostic tests to detect 2009 H1N1 virus in respiratory specimens ranges from 10% to 70%, and therefore false negative results occur frequently. Similarly, false negative results can also occur with immunoflorescence assays.

What actions should healthcare providers take when waiting for influenza test results?

Healthcare providers should empirically treat persons with suspected influenza illness who are at increased risk for complications if clinically indicated while influenza test results are pending. Antiviral treatment is most effective when administered as early as possible in the course of illness. The rRT-PCR tests are the most sensitive and specific influenza diagnostic tests, but they may not be readily available, obtaining test results may take one to several days, and test performance depends on the individual rRT-PCR assay. Antiviral treatment should not be delayed until rRT-PCR test results are available.

For More Information

Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season:
http://www.cdc.gov/H1N1flu/recommendations.htm

Interim Recommendations for Clinical Use of Influenza Diagnostic Tests During the 2009-10 Influenza Season:
http://www.cdc.gov/h1n1flu/guidance/diagnostic_tests.htm

Questions & Answers:

Antiviral Drugs, 2009-2010 Flu Season:
http://www.cdc.gov/h1n1flu/antiviral.htm

Influenza Diagnostic Testing:
http://www.cdc.gov/h1n1flu/diagnostic_testing_clinicians_qa.htm

Updated Interim Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season:
http://www.cdc.gov/H1N1flu/pregnancy/antiviral_messages.htm

Antiviral Drugs: Summary of Side Effects:
http://www.cdc.gov/flu/protect/antiviral/sideeffects.htm

General information for the public on antiviral drugs is available in "2009 H1N1 and Seasonal Flu: What You Should Know About Flu Antiviral Drugs" at
http://www.cdc.gov/H1N1flu/antivirals/geninfo.htm

Downloadable brochures and informational flyers, including one on antiviral drugs, are available at
http://www.cdc.gov/h1n1flu/flyers.htm

For the FDA page on antiviral influenza drugs:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm

For additional information, you can also call CDC's toll-free hotline, (800) CDC-INFO [(800)232-4636] TTY: (888) 232-6348, which is available 24 hours a day, every day.

The Health Advisory has not been posted as IAC Express goes to press. To access it in the future, go to: http://www2a.cdc.gov/han Click on the link titled HAN Message Archive in the left column.

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4 Seasonal influenza vaccine pocket guides--FREE!--from the National Influenza Vaccine Summit

With vaccination against 2009 H1N1 influenza underway, it is important to remember that seasonal influenza vaccination efforts must continue. To aid in these efforts, the Immunization Action Coalition is inviting IAC Express readers to place orders now for the National Influenza Vaccine Summit's 2009-10 Seasonal Influenza Vaccination Pocket Information Guides. They're free!

These laminated, 3.75 x 6.75-inch, 2-color cards serve as a convenient reference for front-line healthcare professionals who vaccinate patients. The cards provide the following information:

  • Indications, contraindications, and precautions for the injectable and intranasal seasonal influenza vaccines
     
  • Populations targeted for seasonal influenza vaccination
     
  • Dosage and route of administration for all the various seasonal influenza vaccine products
     
  • Talking points for discussing seasonal influenza vaccination with patients

See an image of the seasonal influenza vaccine pocket guide at
http://www.preventinfluenza.org/fluguide/pocketguide_flu.pdf

These pocket guides also serve as a reminder to keep giving seasonal influenza vaccine throughout influenza season (through the spring months).

The Summit is also pleased to be able to offer pocket guides for the administration of pneumococcal polysaccharide vaccine (PPSV). See an image of the PPSV pocket guide at
http://www.immunize.org/ppvguide/pocketguide.pdf

Each of these pocket guides is designed to be used by healthcare professionals only; THEY ARE NOT PATIENT HANDOUTS.

HOW TO ORDER
Each order must be for a minimum of 100 pocket guides. Place your order at http://www.preventinfluenza.org/pocketguides There is no cost for the pocket guides, shipping, or handling within the U.S. Quantities are limited, so to avoid disappointment, place your order today!

If you have questions, email admininfo@immunize.org

BACKGROUND
These pocket guides were developed by, and are being provided under the sponsorship of the National Influenza Vaccine Summit, http://www.preventinfluenza.org The Summit brings together public and private stakeholders to facilitate and promote influenza vaccination. The pocket guides are also distributed by many major medical, nursing, and pharmacist organizations, specialty societies, state health departments, Indian Health Service Area facilities, Quality Improvement Organizations, Visiting Nurse Associations, community vaccinators, and many others.

Thanks for your dedication to immunization, and don't forget to keep vaccinating against seasonal influenza through the spring months!

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5 Eleven more organizations that mandate influenza vaccination of healthcare workers join IAC's Honor Roll for Patient Safety

Since announcing the Honor Roll for Patient Safety in the October 12 issue of IAC Express, membership has almost doubled, with 11 more healthcare organizations joining the 12 that were previously enrolled. The honor roll recognizes hospitals, professional organizations, and government entities that have taken a stand for patient safety by strengthening mandatory influenza vaccination policies for healthcare workers.

Vaccination is one of the most effective ways to prevent influenza transmission in healthcare settings, but U.S. healthcare worker influenza vaccination rates have only reached 50 percent. Key elements of the stronger policies that have recently been initiated in some healthcare settings are the inclusion of barrier measures to prevent influenza transmission and the discontinuation of policies that allowed workers to exempt themselves from influenza vaccination because of their personal beliefs.

The 11 organizations that have joined since October 12 are Atlanta ID Group, GA; Battle Creek Health Systems, MI; Bronson Methodist Hospital, Battle Creek, MI; Brookwood Medical Center, Birmingham, AL; BS Healthcare Management/St. Jude Medical Center, Fullerton, CA; Kewanee Hospital, IL; Lakeview Medical Center, Rice Lake, WI; Long Beach Memorial Medical Center, CA; Michigan State University/Kalamazoo Center for Medical Studies; Miller Children's Hospital, Long Beach, CA; and Saddleback Memorial Medical Center, Laguna Hills, CA.

To find out specific information on the mandates of these organizations and the 12 previously enrolled organizations, go to:
http://www.immunize.org/laws/influenzahcw.asp

JOIN THE HONOR ROLL TODAY
To be included in the honor roll, your organization's mandate must require influenza vaccination for employees and must include serious measures to prevent transmission of influenza from unvaccinated workers to patients. Such measures might include a mask requirement, reassignment to non-patient-care duties, or dismissal of the employee.

Fill out this online form to tell IAC about influenza vaccination mandates in your healthcare setting:
http://www.immunize.org/laws/mandates.aspx

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6 Important: During H1N1 influenza outbreak, administer PPSV to all people with existing indications

CDC advises healthcare professionals that during the current outbreak of novel influenza A (H1N1), all people who have existing indications for pneumococcal polysaccharide vaccine (PPSV) should be vaccinated according to current ACIP recommendations. This is important because people with existing indications are not only at increased risk for pneumococcal disease, but are also at increased risk for serious complications from influenza. Use of PPSV among people without current indications for vaccination is not recommended at this time.

To access CDC's comprehensive document "Interim guidance for use of 23-valent pneumococcal polysaccharide vaccine during novel influenza A (H1N1) outbreak," go to:
http://www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm

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7 CDC updates its H1N1 web section with information on infection control and more

CDC recently posted four documents related to H1N1 influenza that will be of particular interest to health departments, hospitals, and other medical settings:

(1) Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel
http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

(2) Questions and Answers about CDC's Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel
http://www.cdc.gov/H1N1flu/guidance/control_measures_qa.htm

(3) Questions and Answers Regarding Respiratory Protection for Preventing 2009 H1N1 Influenza Among Healthcare Personnel
http://www.cdc.gov/h1n1flu/guidelines_infection_control_qa.htm

(4) Interim Guidance for Influenza Surveillance: Prioritizing RT-PCR Testing in Laboratories
http://www.cdc.gov/h1n1flu/screening.htm

CDC's H1N1 Flu web section contains hundreds of documents for healthcare professionals and the public. To access the web section's home page, go to: http://www.cdc.gov/h1n1flu

To make it easy for you to keep up to date with developments, IAC has gathered important information related to H1N1 influenza into a single web section. To access this resource, go to: http://www.immunize.org/h1n1

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8 Keep vaccinating against seasonal influenza!

If you're wondering if you should continue to vaccinate against seasonal influenza once H1N1 influenza vaccine becomes available, the answer is YES! The 2009 H1N1 influenza vaccine will not protect people against seasonal influenza, and seasonal influenza vaccine will not protect against H1N1 influenza.

Unfortunately, some healthcare facilities are having difficulty finding available vaccine to purchase. Be assured that though seasonal influenza vaccine may be in temporary short supply in some settings right now, supplies are expected to catch up to demand soon.

To assist providers in finding seasonal influenza vaccine available for purchase, the National Influenza Vaccine Summit supports IVATS (Influenza Vaccine Availability Tracking System). IVATS provides information about vaccine manufacturers and distributors with vaccine available for purchase. To access this information in Excel spreadsheet format, go to:
http://www.preventinfluenza.org/ivats/ivats_09_10.xls

Many resources regarding influenza disease and vaccination are available to healthcare professionals and the public. Following is a list of some of them.

To access the National Influenza Vaccine Summit website, go to:
http://www.preventinfluenza.org

To access IAC's Seasonal Influenza web section, go to:
http://www.immunize.org/influenza

To access IAC's H1N1 Influenza web section, go to:
http://www.immunize.org/h1n1

To access CDC's Seasonal Flu web section, go to:
http://www.cdc.gov/flu

To access CDC's Novel H1N1 Flu web section, go to:
http://www.cdc.gov/h1n1flu

To access IAC's print pieces related to influenza, including screening questionnaires, patient education pieces, and sample standing orders, go to:
http://www.immunize.org/printmaterials/dis_inf.asp

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9 FDA warns consumers about unapproved and illegal H1N1 drug products purchased over the Internet

On October 15, FDA issued a press release titled FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet. Portions of it are reprinted below.


The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat, or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The website disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat, or cure the H1N1 influenza virus from other websites.

These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a healthcare professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus. . . .

Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from websites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur. . . .

The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their healthcare provider if they have any questions or concerns about medical products or personal protective equipment. . . .

The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products.

Consumers can also visit FDA's website for tips about how to protect themselves when buying medicines online
(http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm).

To access the complete press release, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm

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10.  Book about families and individuals devastated by vaccine-preventable diseases is a must for every waiting room

Parents' never-ending regret over not vaccinating their children seemingly goes back to the dawn of vaccination. As recounted in the opening pages of a powerful new book, "Vaccine-Preventable Disease: The forgotten story," Benjamin Franklin, in his 1791 autobiography, lamented that he bitterly regretted a decision he had made 55 years before to forego having one of his sons vaccinated against smallpox out of fear that vaccination could be harmful. At age 4, the boy contracted the disease and died.

Written by vaccination experts at Texas Children's Hospital, "Vaccine-Preventable Disease: The forgotten story" is a 60-page collection of 17 profiles of families and individuals who have recently experienced the devastating impact of infection with one of 12 different vaccine- preventable diseases. As is stated in the introduction, "Each profile in this book puts a face on the statistics and shows the true cost in human suffering of not vaccinating. Each person thought it would never happen in his or her family. All would, in a heartbeat, grab the chance to rewrite history by immunizing themselves or their loved ones against disease."

Replete with photographs, and priced at $3 per copy, this well-written, persuasive book deserves to be at the fingertips of healthcare professionals in clinics and practices that see parents and patients who question the necessity of vaccination in 21st-century America. Stock the book in every waiting room and exam room, and hand it out to people who need an extra dose of convincing.

To access a preview of the book, which includes a synopsis of three of the profiles, go to:
http://www.texaschildrens.org/carecenters/vaccine/Vaccine_Book

The price per copy is $3, plus shipping and handling. To place an order, go to:
https://www.tchorderprocessing.com

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11.  IAC's Video of the Week features Sesame Street's Elmo demonstrating easy ways to stay healthy

IAC encourages IAC Express readers to watch Elmo's 30-scond public service announcement (PSA), which gives children, parents, and teachers accurate information on proper hand-washing and other everyday actions that lead to staying healthy and keeping germs away. In addition, be sure to visit http://www.flu.gov/psa to view other PSAs (in English and Spanish) specifically designed to reach children, parents, pregnant women, and young adults.

The featured Elmo PSA will be available on the home page of IAC's website through October 25. To access it, go to: http://www.immunize.org and click on the image under the words Video of the Week. It may take a few moments for the video to begin playing; please be patient!

Remember to bookmark IAC's home page to view a new video every Monday. To view an IAC Video of the Week from the past, go to the video archive at http://www.immunize.org/votw

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12.  VISs for 2009 H1N1 influenza vaccines available in up to 10 additional languages

Dated 10/2/09, the VISs for 2009 H1N1 inactivated influenza vaccine (injectable) and 2009 H1N1 live attenuated influenza vaccine (nasal spray) are now available in Arabic, Bengali, Chinese, French, Haitian, Korean, Russian, Tagalog, and Urdu. The VIS for the injectable 2009 H1N1 vaccine is also available in Turkish. IAC gratefully acknowledges the New York City Department of Health and Mental Hygiene for the Arabic, Bengali, Chinese, French, Haitian, Korean, Russian, and Urdu translations; California Department of Public Health, Immunization Branch, for the Tagalog translation; and Mustafa Kozanoglu, MD, and Murat Serbest, MD, for the Turkish translation.

NOTE: VISs for the two 2009 H1N1 vaccines are also available in English and Spanish. Links to VISs in those languages are given below.

VISs FOR THE INJECTABLE 2009 H1N1 INFLUENZA VACCINE

To access the Arabic version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ab_h1n1_inact.pdf

To access the Bengali version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/be_h1n1_inact.pdf

To access the Chinese version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ch_h1n1_inact.pdf

To access the French version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/fr_h1n1_inact.pdf

To access the Haitian version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ha_h1n1_inact.pdf

To access the Korean version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ko_h1n1_inact.pdf

To access the Russian version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ru_h1n1_inact.pdf

To access the Tagalog version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ta_h1n1_inact.pdf

To access the Turkish version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/tu_h1n1_inact.pdf

To access the Urdu version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ur_h1n1_inact.pdf

To access the English version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/h1n1_inactiveflu.pdf

To access the Spanish version of the VIS for the injectable 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/sp_h1n1_inact.pdf

VISs FOR THE NASAL-SPRAY 2009 H1N1 INFLUENZA VACCINE

To access the Arabic version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ab_h1n1_live.pdf

To access the Bengali version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/be_h1n1_live.pdf

To access the Chinese version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ch_h1n1_live.pdf

To access the French version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/fr_h1n1_live.pdf

To access the Haitian version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ha_h1n1_live.pdf

To access the Korean version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ko_h1n1_live.pdf

To access the Russian version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ru_h1n1_live.pdf

To access the Tagalog version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ta_h1n1_live.pdf

To access the Urdu version of the VIS for the nasal-spray 2009 H1N1 influenza vaccine, go to:
http://www.immunize.org/vis/ur_h1n1_live.pdf

To access the English version of the VIS for the nasal-spray 2009 H1N1 vaccine, go to:
http://www.immunize.org/vis/h1n1_liveflu.pdf

To access the Spanish version of the VIS for the nasal-spray 2009 H1N1 vaccine, go to:
http://www.immunize.org/vis/sp_h1n1_live.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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13.  VISs for seasonal influenza vaccines available in Hmong, Karen, Russian, and Somali

Dated 8/11/09, the interim VIS for seasonal trivalent inactivated influenza vaccine (TIV; injectable) and the VIS for seasonal live attenuated influenza vaccine (LAIV; nasal spray) are now available in Hmong, Karen (spoken in Burma and Thailand), Russian, and Somali. IAC gratefully acknowledges the Minnesota Department of Health for the translations.

INTERIM VIS FOR THE SEASONAL INJECTABLE INFLUENZA VACCINE

To access the Hmong version of the interim VIS for seasonal injectable influenza vaccine, go to:
http://www.immunize.org/vis/hm_flu04.pdf

To access the Karen version of the interim VIS for seasonal injectable influenza vaccine, go to:
http://www.immunize.org/vis/ka_flu.pdf

To access the Russian version of the interim VIS for seasonal injectable influenza vaccine, go to:
http://www.immunize.org/vis/ru_flu05.pdf

To access the Somali version of the interim VIS for seasonal injectable influenza vaccine, go to:
http://www.immunize.org/vis/so_flu05.pdf

To access the English version of the interim VIS for seasonal injectable influenza vaccine, go to:
http://www.immunize.org/vis/2flu.pdf

NOTE: The interim VIS for seasonal injectable influenza vaccine comes in additional languages, including Spanish. To access them, go to: http://www.immunize.org/vis/vis_flu_inactive.asp Click on the link to the pertinent language.

VIS FOR THE SEASONAL NASAL-SPRAY INFLUENZA VACCINE

To access the Hmong version of the VIS for seasonal nasal-spray influenza vaccine, go to:
http://www.immunize.org/vis/hmLAIV04.pdf

To access the Karen version of the VIS for seasonal nasal-spray influenza vaccine, go to:
http://www.immunize.org/vis/ka_LAIV.pdf

To access the Russian version of the VIS for seasonal nasal-spray influenza vaccine, go to:
http://www.immunize.org/vis/ru_LAIV05.pdf

To access the Somali version of the VIS for seasonal nasal-spray influenza vaccine, go to:
http://www.immunize.org/vis/so_LAIV05.pdf

To access the English version of the VIS for seasonal nasal-spray influenza vaccine, go to:
http://www.immunize.org/vis/liveflu.pdf

NOTE: The VIS for seasonal nasal-spray influenza vaccine comes in additional languages, including Spanish. To access them, go to: http://www.immunize.org/vis/vis_flu_live.asp Click on the link to the pertinent language.

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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14.  IAC's padded screening questionnaires for contraindications now have English on front, Spanish on back--a popular translation at no added cost!

In response to demand, IAC now has a Spanish-language translation of the questions on its padded Screening Questionnaire for Child and Teen Immunization and Screening Questionnaire for Adult Immunization. Printed on the back of the English form, the Spanish form has been added to this product at no additional cost.

The questionnaires give you and your patients a quick, easy, and thorough way to determine if they have contraindications and precautions to vaccination. Patients fill out the questionnaire with yes-or-no answers while waiting to be seen, allowing you to review their responses quickly and be confident you're not missing any contraindications or precautions.

The questionnaires come in convenient tear-off pads of 100 sheets. The price per pad is economical (discounts for two pads or more), so you'll be able to keep pads at the receptionist's desk, the nurse's station, and in every exam room. Each pad comes with four English-language reference sheets (printed on heavy-weight paper) for health professionals.

Prices start at $16 each for one pad and drop to $12 each for two, $11 each for three, and $10 each for four. For quotes on larger quantities or customizing, call (651) 647-9009 or email admininfo@immunize.org

To learn more about the padded screening questionnaires, or to order online or download an order form, visit the following:

Screening Questionnaire for Child and Teen Immunization
http://www.immunize.org/shop/pad_sqchild.asp

Screening Questionnaire for Adult Immunization
http://www.immunize.org/shop/pad_sqadult.asp

IAC's offers other products for sale, including educational videos and personal immunization record cards, at
http://www.immunize.org/shop

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15.  CDC's Pre-teen Vaccine Campaign now has materials for Native American, Korean, and Vietnamese audiences

CDC's Pre-teen Vaccine Campaign includes posters, flyers, web buttons, and PSAs that educate parents and providers about recommended pre-teen vaccines and the 11 and 12 year old medical check-up. The campaign web section was recently updated with materials for Native American, Korean, and Vietnamese audiences. Materials also are also available for African American, Caucasian, and Hispanic audiences.

To access these materials, go to: http://www.cdc.gov/vaccines/spec-grps/preteens-adol/07gallery and click on the appropriate link.

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16.  CDC's 2010 National Immunization Conference set for April 19-22 in Atlanta; abstracts due December 11

CDC's 2010 National Immunization Conference will be held in Atlanta on April 19-22. People planning to present at the conference will need to submit an abstract electronically by December 11.

To submit an abstract, go to:
http://cdc.confex.com/cdc/nic2010/cfp.cgi

For general information on the conference, go to:
http://www.cdc.gov/vaccines/events/nic

For additional information, contact the conference planning team at (404) 639-8225 or nipnic@cdc.gov

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17.  Summary report from the June 2009 ACIP meeting now onlinerticle 17.

The CDC website recently posted the Summary Report of ACIP's June 24-26 meeting. To access a ready-to-print (PDF) version of the report, go to: http://www.cdc.gov/vaccines/recs/acip/downloads/min-jun09.pdf

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Immunization Action Coalition  •  2550 University Avenue West  •  Suite 415 North  •  Saint Paul, Minnesota  •  55114
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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.