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Immunization Action Coalition
IAC Express 2010
Issue number 858: March 29, 2010
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. CDC and FDA publish Q&As for providers and parents about temporary suspension of Rotarix (GSK)
  2. Global organizations release statements on the use of Rotarix vaccine
  3. MMWR reports on H1N1 influenza in pregnant women who require intensive care
  4. 2010 U.S. immunization schedules available in a variety of formats
  5. IAC updates two resources for parents, one on hepatitis B vaccine for babies and one on rotavirus vaccine
  6. Keep vaccinating against influenza this spring and be sure to also give pneumococcal vaccine when indicated
  7. IAC's Video of the Week teaches young adults about the value of immunization
  8. PPSV and multi-vaccine VISs now available in Thai
  9. IAC posts updated Turkish translations of three popular parent pieces
 
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 858: March 29, 2010
1.  CDC and FDA publish Q&As for providers and parents about temporary suspension of Rotarix (GSK)

On March 26, CDC posted two sets of Q&As online about FDA's recommendation to temporarily suspend use of Rotarix vaccine.

To access "Q&A on Rotarix Vaccine for Healthcare Providers and Public Health Professionals," go to:
http://www.cdc.gov/vaccines/vpd-vac/rotavirus/rotarix-providers.htm

To access "Parents & Caregivers: Q&A about the Rotarix Vaccine and Rotavirus," go to:
http://www.cdc.gov/vaccines/vpd-vac/rotavirus/rotarix-parents.htm

On the same date, FDA updated its Q&As for providers and parents.

To access "Additional Information for Healthcare Providers and Public Health Professionals," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm

To access "Information for Parents and Caregivers," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm

To access the FDA index web page titled "Update on Rotarix Vaccine," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm

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2 Global organizations release statements on the use of Rotarix vaccine

The World Health Organization (WHO) and the Global Advisory Committee on Vaccine Safety (GACVS) released statements last week on the use of Rotarix vaccine. Neither organization recommends suspension of Rotarix use. The statements from WHO and GACVS are reprinted below.


ROTAVIRUS VACCINATION--WORLD HEALTH ORGANIZATION DOES NOT RECOMMEND ANY CHANGE TO USE OF ROTARIX VACCINE

Following announcements today by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding use of the rotavirus vaccine, Rotarix, the World Health Organization (WHO) encourages all countries using the vaccine to carefully consider the significant benefits of continued use of the vaccine in any decisions about further use.

The FDA and EMA statements follow the recent report to the vaccine manufacturer that DNA sequences originating from porcine circovirus 1 (PCV1) had been detected in two batches of the vaccine during a study undertaken in the United States of America.

WHO concurs with the views of the FDA and EMA that the findings do not present a threat to public health. Moreover, rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the world, with an estimated 527,000 deaths among children under five years old, most of whom live in low-income countries. Therefore, WHO does not recommend any change to use of the vaccine. The vaccine is prequalified by WHO, and the prequalification status remains unchanged.

WHO will continue to work closely with the FDA, EMA, and other regulatory agencies to evaluate further information that the manufacturer will be providing as a matter of urgency.


STATEMENT OF THE GLOBAL ADVISORY COMMITTEE ON VACCINE SAFETY ON ROTARIX

On 25 March 2010, WHO's Global Advisory Committee on Vaccine Safety (GACVS) met by teleconference to review new data on Rotarix, an oral vaccine for prevention of rotavirus gastroenteritis. Academic investigators recently reported to the vaccine manufacturer, GlaxoSmithKline, that the vaccine contains DNA from porcine circovirus type 1 (PCV1). PCV1 is not known to cause disease in animals or humans. Further analysis of the master cell bank and master viral seed used for vaccine production have demonstrated the presence of PCV1 DNA, which in retrospect has been in the vaccine throughout its clinical development, including the prelicensure clinical trials. There are studies underway both by the manufacturer and others that will provide additional information to help more fully assess this new finding.

The safety of Rotarix is supported by both large clinical trials prelicensure and an extensive (>60 million doses) postlicensure safety experience. GACVS reviewed the safety data from both clinical trials and spontaneous reports, both of which supported the continued safety of Rotarix. Rotavirus gastroenteritis is the most common cause of severe diarrheal disease in young children throughout the world, with an estimated 527,000 deaths annually among children under five years old. Given the extensive clinical data supporting the safety of Rotarix and the benefits of rotavirus vaccination for children, GACVS considers that the benefits of vaccination far outweigh any currently known risk associated with use of Rotarix. GACVS will continue to review data as it becomes available and will update this statement as we learn more.


To read the WHO statement online, click here.

To access the GACVS statement online, click here.

To access the WHO position paper on rotavirus vaccines, go to:
http://www.who.int/wer/2009/wer8451_52.pdf

To access the European Medicine Agency's statement about Rotarix, go to:
http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/18935010en.pdf

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3 MMWR reports on H1N1 influenza in pregnant women who require intensive care

CDC published "2009 Pandemic Influenza A (H1N1) in Pregnant Women Requiring Intensive Care--New York City, 2009" in the March 26 issue of MMWR. The first paragraph of the article and the first two paragraphs of the editorial note are reprinted below.


Pregnant women are at increased risk for severe illness and complications from infection with seasonal influenza and 2009 pandemic influenza A (H1N1). To characterize the severity of 2009 H1N1 infection in pregnant women, the New York City Department of Health and Mental Hygiene (DOHMH) conducted active and passive surveillance for cases of 2009 H1N1 infection in pregnant women requiring intensive care. This report summarizes the results of that surveillance, which found that, during 2009, 16 pregnant women and one who was postpartum were admitted to New York City intensive-care units (ICUs). Two women died. Of the 17 women, 12 had no recognized risk factors for severe influenza complications other than pregnancy. All 17 women received antiviral treatment with oseltamivir; however, treatment was initiated <=2 days after symptom onset in only one woman and was begun >=5 days after symptom onset in four women. Because initiation of antiviral treatment <=2 days after onset is associated with better outcomes, pregnant women should be encouraged to seek medical care immediately if they develop influenza-like symptoms, and healthcare providers should initiate empiric antiviral therapy for these women as soon as possible, even if >2 days after symptom onset. Health departments and healthcare providers should educate pregnant and postpartum women regarding the risks posed by influenza and highlight the effectiveness and safety of influenza vaccination. Obstetricians and other healthcare providers should offer influenza vaccination to their pregnant patients. . . .

An analysis of New York City 2009 H1N1 hospitalizations during May-June 2009 showed that pregnant women were 7.2 times more likely to be hospitalized and 4.3 times more likely to be admitted to an ICU than nonpregnant women. Immunologic changes, increased ventilatory demand, and decreased functional residual capacity and oncotic pressure all are postulated to predispose pregnant and postpartum women to severe respiratory complications from influenza virus infection.

The case series in this report highlights some delays in pregnant women seeking care and obtaining appropriate diagnosis and treatment of 2009 H1N1 virus infection in New York City, despite extensive outreach to the public and healthcare providers by public health officials. The illustrative cases highlight some factors contributing to the delays, including false-negative rapid diagnostic test results and not taking oseltamivir as prescribed. In addition, only one of the 17 women was reported to have received 2009 H1N1 vaccine. Although no vaccine is 100% effective, vaccination remains the most important and effective means of preventing influenza among pregnant women. . . .

To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5911a1.htm

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4 2010 U.S. immunization schedules available in a variety of formats

CDC recently released pocket-size versions of the official 2010 childhood and adult immunization schedules. To access the pocket-size schedules, go to:
http://www.cdc.gov/vaccines/recs/schedules/pocketsize.htm

To access the general CDC immunization schedule page, go to:
http://www.cdc.gov/vaccines/recs/schedules

In addition, IAC's popular laminated versions of the full-size 2010 child/teen and adult immunization schedules are now available for ordering. These laminated versions are covered with a tough, washable coating, are printed in color for easy reading, come complete with essential tables and footnotes, and include contraindications and precautions.

Visit the following web pages for specific information, to view images, or to order online or download an order form:

Child and Adolescent Laminated U.S. Immunization Schedules (0-18 years)
http://www.immunize.org/shop/schedule_child.asp

Adult Laminated U.S. Immunization Schedules
http://www.immunize.org/shop/schedule_adult.asp

For quotes on customizing or placing orders in excess of 999 schedules, call (651) 647-9009 or email admininfo@immunize.org

To learn about other essential immunization resources available for purchase from IAC, go to: http://www.immunize.org/shop

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5 IAC updates two resources for parents, one on hepatitis B vaccine for babies and one on rotavirus vaccine

IAC recently revised the following two resources.

The parent brochure "Hepatitis B shots are recommended for all new babies" received minor edits.

To access this revised ready-to-print (PDF) piece, go to:
http://www.immunize.org/catg.d/p4110.pdf

The print piece for parents titled "Rotavirus: Questions and Answers" was updated with new safety information.

To access this revised ready-to-print (PDF) piece, go to:
http://www.immunize.org/catg.d/p4217.pdf

IAC's Print Materials web section offers healthcare professionals and the public approximately 250 FREE English-language materials (many also available in translation), which we encourage website users to print out, copy, and distribute widely. To access all of IAC's free print materials, go to: http://www.immunize.org/printmaterials

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6 Keep vaccinating against influenza this spring and be sure to also give pneumococcal vaccine when indicated

Please continue to vaccinate patients against H1N1 and seasonal influenza (as vaccine supplies permit). Remember: 2009 H1N1 influenza vaccine will not protect people against seasonal influenza, and seasonal influenza vaccine will not protect against H1N1 influenza.

Providers who don't have H1N1 vaccine or seasonal influenza vaccine can direct patients to the Google Flu Shot Finder at http://www.google.com/flushot

Also remember that CDC advises healthcare professionals that during seasonal and H1N1 influenza outbreaks, 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.

CDC has issued related guidance titled "Prevention of Pneumococcal Infections Secondary to Seasonal and 2009 H1N1 Influenza Viruses Infection." To access it, go to:
http://www.cdc.gov/h1n1flu/vaccination/provider/provider_pneumococcal.htm

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7 IAC's Video of the Week teaches young adults about the value of immunization

IAC encourages IAC Express readers to watch a 6-minute video that introduces young adults to the value of immunization. In the video, which was developed by Canada's BC Centre for Disease Control, two teens investigate why some of their familial ancestors did not survive childhood. To access the video, please read the directions below.

The video will be available on the home page of IAC's website through April 4. To access it, go to: http://www.immunize.org and click on the image under the words Video of the Week. This will take you to the Immunization & Vaccines section of the BC Centre for Disease Control. Scroll down to the section titled "Disease Scene Investigation (DSI) Videos for Kids," and click on the video titled "How Immunization Works." 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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8 PPSV and multi-vaccine VISs now available in Thai

The pneumococcal polysaccharide vaccine (PPSV) VIS and the multi-vaccine VIS are now available in Thai. IAC gratefully acknowledges the Asian Pacific Health Care Venture, Inc., for the translations.

To access the PPSV VIS in Thai, go to:
http://www.immunize.org/vis/th_pne97.pdf

To access the multi-vaccine VIS in Thai, go to:
http://www.immunize.org/vis/th_multi.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

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9 IAC posts updated Turkish translations of three popular parent pieces

Mustafa Kozanoglu, MD, kindly updated three popular parent pieces that IAC had recently revised.

To access "Immunizations for Babies: A Guide for Parents--These are the vaccinations your baby needs!" in Turkish, go to: http://www.immunize.org/catg.d/p4010-21.pdf

To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4010.pdf

To access "When Do Children and Teens Need Vaccinations?" in Turkish, go to:
http://www.immunize.org/catg.d/p4050-21.pdf

To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4050.pdf

To access "Are you 11-19? Then you need to be vaccinated against these serious diseases!" in Turkish, go to:
http://www.immunize.org/catg.d/p4020-21.pdf

To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4020.pdf

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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.