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Immunization Action Coalition
IAC Express 2010
Issue number 868: May 17, 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. FDA revises its recommendations for rotavirus vaccine: clinicians can resume use of Rotarix and continue use of RotaTeq
  2. New: CDC revises interim VIS for rotavirus vaccine
  3. IAC's "Hepatitis B shots are recommended for all new babies" now available in Spanish and five other languages
  4. IAC's Video of the Week examines the growing bias against science, including opposition to vaccination
  5. CDC provides information on the supply of shingles and MMRV vaccines
  6. Want to know more about using the new PCV 13 vaccine? A CDC Commentary video on Medscape can help you
  7. PKIDs' June 10 webinar will focus on using social marketing to target parents who are hesitant about vaccines
  8. Please take three minutes out of your day to give PATH feedback about its Vaccine Resource Library
  9. MMWR publishes report on worldwide progress made toward interrupting wild poliovirus transmission during 2009
  10. CDC reports on Regional Vaccination Weeks, held April 24 to May 1, 2010
  11. MMWR corrects errors in its April 30 interim report on seasonal influenza coverage during August 2009-January 2010
  12. MMWR corrects an error in its April 2 interim report on H1N1 influenza coverage during October 2009-January 2010
 
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 868: May 17, 2010
1.  FDA revises its recommendations for rotavirus vaccine: clinicians can resume use of Rotarix and continue use of RotaTeq

On May 14, CDC issued "Update on Recommendations for the Use of Rotavirus Vaccines." It is reprinted below in its entirety.

Also on May 14, FDA posted information for parents and caregivers, information for healthcare providers and the public, and extensive background information. Links to these resources are given at the end of this IAC Express article.


UPDATE ON RECOMMENDATIONS FOR THE USE OF ROTAVIRUS VACCINES

Summary:
FDA is updating its recommendations on both Rotarix and RotaTeq vaccines for the prevention of rotavirus disease in infants. Based on careful evaluation of a variety of scientific information, FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

Background:
On March 22, 2010, FDA provided an early communication regarding Rotarix, manufactured by GlaxoSmithKline Biologicals (GSK). At that time, FDA recommended that clinicians and public health professionals in the United States temporarily suspend the use of Rotarix while the agency and manufacturer investigated the finding of DNA from porcine circovirus type 1 (PCV1) in the vaccine. Since that time, both FDA and GSK have confirmed the presence of PCV1 in the vaccine.

On May 6, 2010, FDA provided information about RotaTeq, manufactured by Merck & Co, Inc. FDA indicated that preliminary studies conducted by Merck identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in RotaTeq. FDA noted that it would seek input from its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and provide updates in the near future.

Updated Recommendations:
FDA has evaluated laboratory results from the manufacturers and its own laboratories. In addition, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on May 7, 2010, to discuss the findings of PCV and PCV DNA in rotavirus vaccines. Based on a careful evaluation of this information, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has determined it is appropriate for clinicians and healthcare professionals to resume the use of Rotarix and to continue the use of RotaTeq.

FDA considered the following information in its decision:
  • Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans.
     
  • The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. and of death in other parts of the world. The benefits of the vaccines, which are known, outweigh the risk, which is theoretical.

Next Steps:
FDA is working with each of the manufacturers (GSK and Merck) to update the labeling for both Rotarix and RotaTeq vaccines to include information about the presence of PCV1 (Rotarix) and DNA from PCV1 and PCV2 (RotaTeq) in the vaccines.

FDA is working with each of the manufacturers to plan the appropriate follow-up studies, taking into account the input received from members of the VRBPAC on May 7, 2010.

FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines, and will evaluate information from ongoing testing by FDA and the manufacturers. As noted by the firm during the May 7, 2010, VRBPAC meeting, GSK plans to re-derive its vaccine, in consultation with FDA. Merck is in the early stages of its investigation, and has not yet determined next steps in this  regard.

Updated Information for Clinicians and Public Health Professionals:
FDA has determined it is appropriate for clinicians and healthcare professionals to resume the use of Rotarix and to continue the use of RotaTeq. FDA also recommends that clinicians and public health professionals inform parents of the findings of PCV DNA or PCV in rotavirus vaccines, and that there is no evidence that these findings pose a safety risk in humans. Both the prescribing information and patient labeling will be revised to include this information.

The benefits of vaccination against rotavirus disease are substantial, both in the United States and the developing world and far outweigh any theoretical risk posed by PCV types 1 and 2. The safety record of both rotavirus vaccines is excellent.

FDA will keep the public and clinical community updated through http://www.fda.gov and other communications.


To access "Update on Recommendations for the Use of Rotavirus Vaccines," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm212140.htm

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

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

To access extensive background information, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm

To access a letter addressed to healthcare professionals from GlaxoSmithKline, go to:
http://www.gsksource.com/gskprm/en/US/images/gsk_content/ROTARIX/RTX343R0-Final.pdf

Note: Merck did not issue a similar letter because FDA has never recommended temporary suspension of RotaTeq, Merck's rotavirus vaccine.

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2 New: CDC revises interim VIS for rotavirus vaccine

On May 14, CDC issued a revised interim VIS for the use of rotavirus vaccine. It replaces the interim VIS dated 8/28/08.

Page 1 of the 5/14/10 interim VIS includes a box with this information: "A virus (or parts of the virus) called porcine circovirus is in both rotavirus vaccines. This virus is not known to infect people and there is no known safety risk. For more information, see http://www.fda.gov"

Note: Providers may use up existing stocks of the 8/28/08 version of the interim VIS. Providers who want ensure that parents are informed about the issue of porcine circovirus may want to use the 5/14/10 version of the interim VIS or to supplement the 8/28/08 version with pertinent materials from FDA such as "Information for Parents and Caregivers"
(http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm).

To access the 5/14/10 interim VIS for rotavirus vaccine from the IAC website, go to:
http://www.immunize.org/vis/vis_rotavirus.asp

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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3 IAC's "Hepatitis B shots are recommended for all new babies" now available in Spanish and five other languages

Updated in March 2010, IAC's parent-education piece "Hepatitis B shots are recommended for all new babies" is now available in Arabic, Chinese, French, Korean, Spanish, and Vietnamese.

To access the Spanish version of "Hepatitis B shots are recommended for all new babies," go to:
http://www.immunize.org/catg.d/p4110-01.pdf

For Arabic: http://www.immunize.org/catg.d/p4110-20.pdf

For Chinese: http://www.immunize.org/catg.d/p4110-08.pdf

For French: http://www.immunize.org/catg.d/p4110-10.pdf

For Korean: http://www.immunize.org/catg.d/p4110-09.pdf

For Vietnamese: http://www.immunize.org/catg.d/p4110-05.pdf

For English: http://www.immunize.org/catg.d/p4110.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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4 IAC's Video of the Week examines the growing bias against science, including opposition to vaccination

IAC encourages IAC Express readers to watch a 16-minute video of writer Michael Specter discussing ideas from his book "Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet and Threatens Our Lives."

The video will be available on the home page of IAC's website through May 24. To access it, go to: http://www.immunize.org and click on the image under the words Video of the Week.

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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5 CDC provides information on the supply of shingles and MMRV vaccines On May 5, CDC updated its Current Vaccine Shortages and Delays web page with the following information about the supply of shingles vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.

"Zostavax [the shingles vaccine manufactured by Merck] is available for order at this time; however, providers will experience backorders, or periods where they are unable to place orders for Zostavax, throughout 2010 and possibly into 2011."

"Merck will begin taking orders for MMRV (ProQuad) beginning May 10, 2010. A limited number of doses will be available for distribution (approximately 1.4 million doses), and how long this supply lasts will depend upon market demand for the vaccine. Merck has adequate supply of both their MMR and varicella vaccines to meet current demand."

NOTE: On May 7, CDC released " Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices." To access it, go to: http://www.cdc.gov/mmwr/pdf/rr/rr5903.pdf

For continuing vaccine supply information, go to CDC's Current Vaccine Shortages and Delays web page at http://www.cdc.gov/vaccines/vac-gen/shortages

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6 Want to know more about using the new PCV 13 vaccine? A CDC Commentary video on Medscape can help you

On May 10, Medscape posted a 5-minute video titled "CDC Commentary: Pneumococcal Disease in Children--New Immunization Recommendations." Featuring CDC's Matthew Moore, MD, MPH, the video gives a brief overview of the CDC recommendations for the use of the new 13-valent pneumococcal conjugate vaccine, PCV13.

To view the video, go to:
http://www.medscape.com/viewarticle/721154

Note: to access the video, you must register with Medscape. There is no charge for this service.

The video is a collaboration between CDC and Medscape; it is one of a series of commentaries designed to deliver CDC's authoritative guidance directly to healthcare professionals. To view the available commentary choices, go to:
http://www.medscape.com/partners/cdc/public/cdc-commentary

Medscape is a free resource for clinicians and other healthcare professionals that provides timely and relevant clinical information.

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7 PKIDs' June 10 webinar will focus on using social marketing to target parents who are hesitant about vaccines

PKIDs (Parents of Kids with Infectious Diseases) has scheduled a one-hour webinar titled "Spotlight on Immunization Hesitancy: Washington State." Planned for June 10, the webinar will present information on how a diverse group of public and private partners in Washington state have developed a social marketing plan intended to increase timely immunizations among children from birth to age 24 months, targeting parents who are hesitant about vaccines.

The webinar is part of Communications Made Easy, a PKIDS' program intended to help immunization educators learn the ropes of social marketing and traditional and social media.

"Spotlight on Immunization Hesitancy: Washington State" is scheduled for June 10 at 9AM Pacific Time. Space is limited and pre-registration is recommended. To register, go to:
https://cc.readytalk.com/cc/schedule/display.do?udc=c2up8vtc89z0

For more information on the Communications Made Easy program, go to: http://www.pkids.org/cme

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8 Please take three minutes out of your day to give PATH feedback about its Vaccine Resource Library

PATH, an international nonprofit organization that enables communities worldwide to break longstanding cycles of poor health, is conducting an online survey about its Vaccine Resource Library (VRL). The goal of the survey is to help PATH determine who is using the website and what type of information is most useful. The VRL offers a collection of high-quality, scientifically accurate documents and links on specific diseases and topics in immunization.

Whether you are a regular user of the VRL or new to the website, take time now to visit the VRL at
http://www.path.org/vaccineresources

And then take three minutes to complete the online survey at
http://www.surveymonkey.com/s/HTWZRF6

PATH thanks you--your valuable feedback will help improve the VRL website.

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9 MMWR publishes report on worldwide progress made toward interrupting wild poliovirus transmission during 2009

CDC published "Progress Toward Interruption of Wild Poliovirus Transmission--Worldwide, 2009" in the May 14 issue of MMWR. The first paragraph is reprinted below.


In 1988, an estimated 350,000 cases of poliomyelitis were occurring annually worldwide. By 2005, because of global vaccination efforts, indigenous transmission of wild poliovirus (WPV) types 1 and 3 (WPV1 and WPV3) had been eliminated from all but four countries (Afghanistan, India, Nigeria, and Pakistan). No cases of WPV type 2 have been reported since 1999. This report describes progress toward global WPV eradication during 2009 and updates previous reports. During 2009 a total of 1,606 cases of WPV infection were reported, compared with 1,651 in 2008. WPV3 incidence increased 67%, to 1,124 cases, compared with 675 in 2008. However, WPV1 incidence decreased 51%, to 482 cases in 2009, compared with 976 cases in 2008. In India, nearly all polio cases in 2009 were reported in high-risk districts in western Uttar Pradesh and central Bihar. In Afghanistan and Pakistan, WPV circulation in high-risk districts continued because of difficulties vaccinating children in conflict-affected areas and operational limitations in parts of Pakistan. In Nigeria, cases decreased by 51%, to 388 cases in 2009, compared with 798 in 2008. During 2009, outbreaks from importation of WPV affected 19 previously polio-free African countries. Two key steps are needed to make further progress in polio eradication: (1) addressing local barriers to interrupting transmission, and (2) using bivalent oral poliovirus vaccine (bOPV) broadly for WPV 1 and 3 in supplemental immunization activities (SIAs).

To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a1.htm

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10.  CDC reports on Regional Vaccination Weeks, held April 24 to May 1, 2010

CDC provided the text below on the Vaccination Weeks sponsored by three World Health Organization regions.


Promoting the life-saving importance of vaccines, strengthening country immunization programs, and increasing access to vaccines were the goals of the Global Vaccination Week that was held April 24 to May 1, 2010. These events were sponsored by three World Health Organization (WHO) regional offices and their member states to promote immunization, increase vaccine access, and strengthen existing programs in the Eastern Mediterranean, Europe, and the Americas regions of the globe. The activities of the regional WHO offices and their member states are part of a growing endeavor to develop an international vaccination week that yearly promotes the life saving potential of immunization reaching out to people across the globe.

"Vaccination is the Obvious Choice" was the theme for the first Vaccination Week in Eastern Mediterranean area. To read about the immunization achievements and challenges of the Eastern Mediterranean area, go to: http://www.emro.who.int/vpi/vwem

The fifth European Immunization Week (EIW) promoted vaccination by emphasizing the importance of vaccinating every child to prevent disease and protect life. For details, go to: http://www.euro.who.int/eiw

Vaccination Week in the Americas (VWA) is an annual hemispheric event that works to strengthen the Expanded Program on Immunization (EPI). For details, go to: http://www.paho.org/vwa

In collaboration with VWA, the United States sponsored National Infant Immunization Week (http://www.cdc.gov/vaccines/events/niiw), and Canada sponsored National Immunization Awareness Week (http://www.immunize.cpha.ca/en/events/niaw.aspx) to promote vaccination during this week.

The convergence of all of these activities during a specific week is building a platform for future vaccination weeks that will annually focus world attention on the importance of vaccination and proclaim the life saving benefits of immunization. As Dr. Margaret Chan, the Director-General of the World Health Organization, has stated, "In the future, I hope we will see even greater numbers of countries participating in these immunization weeks." Next year, Africa is considering launching its regional vaccination week, having participated in the launch in the Americas. It is anticipated that a worldwide Global Vaccination Week will become a reality, and this international effort will become an international event that prevents disease through vaccination.

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11.  MMWR corrects errors in its April 30 interim report on seasonal influenza coverage during August 2009-January 2010

CDC published "Errata: Vol. 59, No. 16" in the May 14 issue of MMWR. The errors concerned details in coverage and range.

To access the errata in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a6.htm

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12.  MMWR corrects an error in its April 2 interim report on H1N1 influenza coverage during October 2009-January 2010

CDC published " Errata: Vol. 59, No. 12" in the May 14 issue
of MMWR. The error concerned a detail in the coverage
information.

To access the errata in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a7.htm

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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.