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Immunization Action Coalition
IAC Express 2010
Issue number 857: March 22, 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 Health Advisory notifies providers about FDA's recommendation to temporarily suspend use of GSK's Rotarix vaccine
  2. MMWR publishes CDC's recommendations for the use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies
  3. MMR vaccine VIS now available in Yiddish
  4. Video presents a mother's powerful narrative of her son's decade-long struggle with complications from chickenpox
  5. Keep vaccinating against H1N1 and seasonal influenza!
  6. Nearly 8 million Afghan children to benefit in latest United Nations polio vaccination drive
  7. Free CME webinar: American College of Preventive Medicine's "H1N1--Lessons Learned" webinar is scheduled for March 24
  8. California Immunization Coalition's 2010 Summit is planned for May 3-4 in Sacramento
 
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 857: March 22, 2010
1.  CDC Health Advisory notifies providers about FDA's recommendation to temporarily suspend use of GSK's Rotarix vaccine

On March 22, CDC issued a Health Advisory titled "Recommendation to Temporarily Suspend Usage of GlaxoSmithKline Rotarix (Rotavirus) Vaccine." The complete text of the advisory is reprinted below.


RECOMMENDATION TO TEMPORARILY SUSPEND USAGE OF GLAXOSMITHKLINE ROTARIX (ROTAVIRUS) VACCINE

Summary: The U.S. Food and Drug Administration (FDA) has learned that DNA from porcine circovirus type 1 (PCV1), a virus not known to cause disease in humans, is present in the Rotarix vaccine. All available evidence indicates that there has been no increased risk to patients who have received this vaccine. PCV1 is not known to cause any disease in animals or humans; therefore, it has not been routinely tested for in vaccine development. Rotarix has been extensively studied, before and after approval, and found to have an excellent safety record (i.e., no unusual adverse events). However, FDA is recommending that healthcare practitioners temporarily suspend usage of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about the detection of components of the virus found in the vaccine.

BACKGROUND

FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in the Rotarix vaccine. This finding was reported to FDA by GlaxoSmithKline on March 15th, 2010, based on work originally performed by an academic research team using a novel technique to look for viruses. GlaxoSmithKline then conducted additional studies and confirmed that PCV1 DNA is present in the finished Rotarix vaccine, as well as in the cell bank and seed from which the vaccine is derived. This finding suggests that the PCV1 DNA has likely been present since the early stages of the vaccine's development.

Rotavirus vaccines are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration. Each year, rotavirus disease causes more than 500,000 deaths in infants globally, and more than 50,000 hospitalizations and several dozen deaths in the United States. There are two licensed rotavirus vaccines in the United States: RotaTeq (Merck) and Rotarix (GlaxoSmithKline).

RECOMMENDATIONS

While FDA is learning more about the situation, the agency is recommending that clinicians temporarily suspend the use of Rotarix. This recommendation applies to all lots of the Rotarix vaccine. RotaTeq vaccine is available for rotavirus immunization during this period. For children who have received one dose of Rotarix, CDC advises that clinicians complete the series with RotaTeq for the next two doses.

Since RotaTeq was licensed in 2006 and Rotarix in 2008, most children vaccinated in the United States received RotaTeq. The RotaTeq vaccine is made using a different process from the Rotarix vaccine. Preliminary studies by FDA on the RotaTeq vaccine have not shown the presence of PCV1 DNA. FDA is working with Merck to confirm these results.

FDA is obtaining additional information about the presence of PCV1 DNA in Rotarix, including whether intact virus (as opposed to DNA components) is present. FDA is also investigating how the PCV1 DNA came to be present in the vaccine.

Within the next four to six weeks, FDA will convene an advisory committee to review the available data and make recommendations on the licensed rotavirus vaccines. FDA will also seek input on the use of new techniques for identifying viruses in vaccines. The agency anticipates that following the advisory committee meeting, based on expert input and additional review, FDA will make further recommendations on the use of the two licensed rotavirus vaccines in the United States.

The recommendations detailed above are for the United States, where there is less rotavirus disease and an alternative vaccine is available. Other countries may decide to continue vaccinating with Rotarix while more information becomes known. Available evidence suggests that the benefits of continued use of Rotarix in countries where rotavirus disease is common and severe far outweigh any potential risk from the vaccine.

Clinicians are requested to report any suspected adverse events following Rotarix vaccination to the Vaccine Adverse Event Reporting System (VAERS) via phone (800) 822-7967 or online: http://vaers.hhs.gov

FOR MORE INFORMATION

FDA intends to provide frequent updates to patients, providers, and the general public as its understanding evolves. Additional information is available at http://www.fda.gov


To access the CDC Health Advisory online, go to:
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00311

To read the related FDA press release, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm

To access a web section of FDA resources related to the suspension of Rotarix use, including Q&As for parents and healthcare providers, click here.

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2 MMWR publishes CDC's recommendations for the use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies

On March 19, CDC published "Use of a Reduced (4-Dose) Vaccine Schedule for Postexposure Prophylaxis to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" in MMWR Recommendations and Reports. The Summary section is reprinted below.


This report summarizes new recommendation and updates previous recommendations of the Advisory Committee on Immunization Practices (ACIP) for postexposure prophylaxis (PEP) to prevent human rabies (CDC. Human rabies prevention--United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR 2008;57[No. RR-3]). Previously, ACIP recommended a 5-dose rabies vaccination regimen with human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV). These new recommendations reduce the number of vaccine doses to four. The reduction in doses recommended for PEP was based in part on evidence from rabies virus pathogenesis data, experimental animal work, clinical studies, and epidemiologic surveillance. These studies indicated that 4 vaccine doses in combination with rabies immune globulin (RIG) elicited adequate immune responses and that a fifth dose of vaccine did not contribute to more favorable outcomes. For persons previously unvaccinated with rabies vaccine, the reduced regimen of 4 1-mL doses of HDCV or PCECV should be administered intramuscularly. The first dose of the 4-dose course should be administered as soon as possible after exposure (day 0). Additional doses then should be administered on days 3, 7, and 14 after the first vaccination. ACIP recommendations for the use of RIG remain unchanged. For persons who previously received a complete vaccination series (pre- or postexposure prophylaxis) with a cell-culture vaccine or who previously had a documented adequate rabies virus-neutralizing antibody titer following vaccination with noncell-culture vaccine, the recommendation for a 2-dose PEP vaccination series has not changed. Similarly, the number of doses recommended for persons with altered immunocompetence has not changed; for such persons, PEP should continue to comprise a 5-dose vaccination regimen with 1 dose of RIG. Recommendations for pre-exposure prophylaxis also remain unchanged, with 3 doses of vaccine administered on days 0, 7, and 21 or 28. Prompt rabies PEP combining wound care, infiltration of RIG into and around the wound, and multiple doses of rabies cell-culture vaccine continue to be highly effective in preventing human rabies.


To access the complete recommendations in PDF format, go to:
http://www.cdc.gov/mmwr/pdf/rr/rr5902.pdf

For the document in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5902a1.htm

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3 MMR vaccine VIS now available in Yiddish

Dated 3/13/08, the current VIS for measles-mumps-rubella (MMR) vaccine is now available in Yiddish. IAC gratefully acknowledges the New York City Department of Education and New York City Department of Health and Mental Hygiene for the translation.

To access the Yiddish version of the 3/13/08 VIS for MMR vaccine, go to: http://www.immunize.org/vis/yi_mmr.pdf

To access the English version of the 3/13/08 VIS for MMR vaccine, go to: http://www.immunize.org/vis/mmr03.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 more information about the ongoing multi-state mumps outbreak, see the Health Advisory released by CDC on March 11 titled "Notice to Providers Concerning Potential Cases of Mumps During a Multi-State Outbreak" at: http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00310

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4 Video presents a mother's powerful narrative of her son's decade-long struggle with complications from chickenpox

IAC encourages IAC Express readers to watch a 3-minute video that recounts how one family's life was forever changed by their son's experience with chickenpox. The video was produced by PKIDS (Parents of Kids with Infectious Diseases).

The video will be available on the home page of IAC's website through March 28. 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!

To view more excellent videos about other vaccine-preventable diseases from PKIDS, go to http://www.pkids.org/im_videos.php

To find out more about PKIDS, go to: http://www.pkids.org

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 Keep vaccinating against H1N1 and seasonal influenza!

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

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6 Nearly 8 million Afghan children to benefit in latest United Nations polio vaccination drive

On March 14, United Nations agencies and the Afghan health ministry started conducting a 3-day campaign aimed at vaccinating an estimated 7.7 million children under age 5 years against polio. Afghanistan is one of four countries where polio is still endemic.

To read the entire press release, go to:
http://www.un.org/apps/news/story.asp?NewsID=34080&Cr=afghan&Cr1=

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7 Free CME webinar: American College of Preventive Medicine's "H1N1--Lessons Learned" webinar is scheduled for March 24

The American College of Preventive Medicine has scheduled a live, interactive webinar, "H1N1--Lessons Learned," for March 24 at 7PM ET. Participants can earn free CME credit by viewing the presentation, completing a self-assessment and evaluation form, and submitting it.

For information on the faculty, course objectives, and system requirements, click here.

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8 California Immunization Coalition's 2010 Summit is planned for May 3-4 in Sacramento

"Preparing For Tomorrow, Taking Action Today" is the theme of the California Immunization Coalition's 2010 Summit. It will be held in Sacramento on May 3-4. The two day Summit will feature speakers, expert panels, workshops, and important opportunities for discussion with some of the top leaders in immunization and healthcare advocacy in California and beyond.

This year's Summit speakers include Litjen (LJ) Tan, PhD, Director of Medicine and Public Health at the American Medical Association; Tom T. Shimabukuro, MD, Deputy Director H1N1 Vaccine Task Force at CDC; and Lisa Randall, Associate Executive Director, Immunization Action Coalition.

Individuals from outside California are welcome to attend.

For comprehensive information, go to:
http://immunizeca.org/summit.cfm

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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.