IAC Express 2010
Issue number 848: January 27, 2010
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Contents of this Issue
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  1. Read "Ask the Experts" Q&As on new vaccine recommendations and licensures
 
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 848: January 27, 2010
1.  Read "Ask the Experts" Q&As on new vaccine recommendations and licensures

Many readers of Needle Tips and Vaccinate Adults consistently rank "Ask the Experts" as their favorite feature in these publications. As a thank-you to our loyal IAC Express readers, we periodically publish Extra Editions with new "Ask the Experts" Q&As answered by CDC experts.

IAC thanks William L. Atkinson, MD, MPH, and Andrew T. Kroger, MD, MPH, medical epidemiologists, at the National Center for Immunization and Respiratory Diseases, CDC, for agreeing to answer the following questions.

Almost all the Q&As in this edition of IAC Express deal with new immunization recommendations and vaccine licensures.

We encourage you to reprint any of these Q&As in your own newsletters. Please credit the Immunization Action Coalition and the Centers for Disease Control and Prevention. Information about IAC's preferred citation style can be found at http://www.immunize.org/citeiac

You can access more "Ask the Experts" Q&As in our online archive at http://www.immunize.org/askexperts

Editor's note: Information about submitting a question to "Ask the Experts" is provided at the end of this Extra Edition.


Q: Please review the recommendations for the use of the two human papillomavirus (HPV) vaccines, Cervarix (GSK) and Gardasil (Merck). What are the differences between them?

A: Cervarix is an inactivated bivalent vaccine (HPV2) that protects against HPV types 16 and 18. Gardasil is an inactivated quadrivalent vaccine (HPV4) that protects against HPV types 16 and 18, and also against types 6 and 11, which are human papillomaviruses that cause genital warts.

For prevention of cervical cancers and precancers, ACIP recommends that females ages 9 through 26 years be vaccinated with either Cervarix or Gardasil. To prevent genital warts, as well as cervical cancers and precancers, ACIP recommends vaccination with Gardasil. Gardasil may also be given to males ages 9 through 26 years to reduce their likelihood of acquiring genital warts.

Ideally, the HPV vaccine should be administered before potential exposure to HPV through sexual contact. Therefore, for prevention of cervical cancers and precancers, ACIP recommends that females ages 11 or 12 years be routinely vaccinated with either Cervarix or Gardasil. HPV vaccination also is recommended for females ages 13 through 26 years who have not been previously vaccinated or who have not completed the full vaccination series. The vaccination series can be started in males and females beginning at age 9 years.

Both HPV vaccines are administered in a 3-dose schedule, with the second dose administered 1 to 2 months after the first dose and the third dose 6 months after the first dose. The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum interval between the second and third doses of vaccine is 12 weeks. The minimum interval between the first and third doses is 24 weeks.

Whenever possible, use the same brand of HPV vaccine for all doses in the series. In situations when that's not possible, use the second HPV brand to complete the series. A total of 3 doses of HPV vaccine (either of a single brand or of a combination of brands) completes the series. Do not start the series over again. If fewer than 3 doses of Gardasil are received, protection against HPV types 6 and 11 may not be adequate.

To access the provisional recommendations for HPV vaccine, go to:
http://www.cdc.gov/vaccines/recs/provisional/downloads/hpv-vac-dec2009-508.pdf


Q: What are the recommendations for using Gardasil to prevent genital warts in boys and men?

A: ACIP's provisional recommendations state: "The 3-dose series of quadrivalent HPV vaccine may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts." The schedule and minimum intervals are the same as for females. See the question and answer above for details.


Q: Use of HPV vaccine is covered under the Vaccines for Children (VFC) program. Can VFC-eligible boys receive HPV vaccine under the program?

A: Yes. Since ACIP states that Gardasil can be administered to males to protect them from genital warts, VFC vaccine provided by the VFC program can be used for VFC-eligible males ages 9 through 18 years.


Q: Please describe the recommendations for the use of the Japanese encephalitis (JE) vaccine, Ixiaro (Intercell Biomedical).

A: FDA licensed Ixiaro in March 2009. The other U.S.-licensed vaccine, JE-VAX, available in the U.S. since 1992, is no longer being manufactured, but existing supplies are still available for children ages 1 through 16 years who are at risk for exposure to Japanese encephalitis.

Ixiaro is indicated for the prevention of disease caused by Japanese encephalitis virus (JEV) in people age 17 years and older. People for whom Ixiaro vaccination is indicated (i.e., travelers age 17 and older who plan to spend a month or longer in endemic areas during the JEV transmission season) should receive 2 doses administered IM 28 days apart. The series should be completed at least 1 week prior to potential exposure to JEV. There are no data on the interchangeability of JE-VAX and Ixiaro. Persons who have received 1 or 2 doses of JE-VAX in the past should receive a full series of 2 doses of Ixiaro (separated by at least 28 days) if they are still at risk of exposure to Japanese encephalitis.

To access the provisional recommendations for JE vaccine, go to:
http://www.cdc.gov/vaccines/recs/provisional/downloads/je-july2009-508.pdf

The Ixiaro package insert is located at
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142570.pdf

Information about the 1993 recommendations for use of JE-VAX is available at http://www.cdc.gov/mmwr/pdf/rr/rr4201.pdf


Q: What's new regarding yellow fever vaccination recommendations?

A: On December 9, 2009, CDC posted provisional recommendations for use of yellow fever (YF) vaccine. The provisional recommendations include two new contraindications and one new precaution to YF vaccination.

YF vaccine is now contraindicated for people whose immunologic response is either suppressed or modulated by current or recent radiation therapy or drugs, and for people with thymus disorders associated with abnormal immune cell function, such as thymomas.

Being age 60 years or older years is now a precaution for YF vaccine administration, especially for people who have not previously received YF vaccine.

To access the provisional recommendations for yellow fever vaccine, go to:
http://www.cdc.gov/vaccines/recs/provisional/downloads/yf-vac-dec-2009-508.pdf


Q: Is CDC planning to release any new or updated VISs in the near future?

A: On October 6, 2009, CDC released three new VISs, one for zoster vaccine, one for PPSV, and one for rabies. New and updated VISs that will likely be available within the next few months include MMRV, HPV, Japanese encephalitis, yellow fever, anthrax, and PCV. You can find the latest news about VIS changes on CDC's web page at http://www.cdc.gov/vaccines/pubs/vis/vis-news.htm

All English-language VISs, as well as translations in more than 30 languages, are available on IAC's website at http://www.immunize.org/vis In addition, IAC always informs IAC Express subscribers about new and revised VISs as soon as they are released. To subscribe to IAC Express, go to http://www.immunize.org/subscribe


Q: Can you give me a list of all the currently available seasonal and H1N1 influenza vaccine products?

A: IAC has developed a print piece that includes information (manufacturer, trade name, presentation, mercury content, and age indication) for all currently available seasonal and H1N1 influenza vaccines. To access "Influenza Vaccine Products for the 2009-2010 Influenza Season," go to http://www.immunize.org/catg.d/p4072.pdf


Q: I understand that both sanofi pasteur and MedImmune recalled some H1N1 influenza vaccine lots at the end of 2009. Was safety an issue? Do we have to recall patients to re-vaccinate them?

A: No to both questions. Both recalls were voluntary, limited, and not safety-related.

As part of their ongoing quality assurance programs, MedImmune and sanofi pasteur both discovered the potency levels of certain lots of their H1N1 influenza vaccine had decreased below a pre-specified limit or were at risk of falling below that limit soon. MedImmune voluntarily recalled 13 lots of 2009 H1N1 nasal spray vaccine and sanofi pasteur voluntarily recalled 4 lots of single-dose, prefilled-syringe pediatric (0.25 mL) H1N1 vaccine.

The slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination, and a person who received a dose from one of the recalled vaccine lots does not need to be re-vaccinated. These lots of vaccine pose no safety concerns.

For more information on the MedImmune recall, including affected lot numbers, go to:
http://www.cdc.gov/h1n1flu/vaccination/sprayrecall_qa.htm

For more information on the sanofi pasteur recall, including affected lot numbers, go to:
http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm


Q: Is enough H1N1 influenza vaccine available now to start vaccinating people who are not in one of the targeted high-risk groups?

A: Supplies of vaccines that protect against the 2009 H1N1 virus are increasing. In areas where health department jurisdictions recommend it, providers can give 2009 H1N1 vaccine to anyone who wants it. Most states already allow this, and CDC is encouraging people who have been patiently waiting to receive the 2009 H1N1 vaccine to get vaccinated now.

Vaccination is the best defense against both H1N1 and seasonal influenza. Although H1N1 influenza activity in the United States has recently decreased, seasonal and H1N1 influenza viruses are expected to continue circulating for months. Influenza is unpredictable, and another wave of H1N1 activity could begin at any time. Providers are encouraged to continue vaccinating patients throughout influenza season, including the spring months.


HOW TO SUBMIT A QUESTION TO "ASK THE EXPERTS"
IAC works with CDC to compile new "Ask the Experts" Q&As for our publications based on commonly asked questions. We also consider the need to provide information about new vaccines and recommendations. Most of the questions are thus a composite of several inquiries.

You can email your question about vaccines or immunization to IAC at admin@immunize.org As we receive hundreds of emails each month, we cannot guarantee that we will print your specific question in the "Ask the Experts" feature. However, you will get an answer. To see if your question has already been answered, you can first check the "Ask the Experts" online archive at http://www.immunize.org/askexperts

You can also email CDC's immunization experts directly at nipinfo@cdc.gov There is no charge for this service.

If you have a question about IAC materials or services, email admininfo@immunize.org

Please forward these "Ask the Experts" Q&As to your co-workers and suggest they subscribe to IAC Express at http://www.immunize.org/subscribe

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IZ Express is supported in part by Grant No. 1NH23IP922654 from CDC’s National Center for Immunization and Respiratory Diseases. Its contents are solely the responsibility of Immunize.org and do not necessarily represent the official views of CDC.

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Editorial Information

  • Editor-in-Chief
    Kelly L. Moore, MD, MPH
  • Managing Editor
    John D. Grabenstein, RPh, PhD
  • Associate Editor
    Sharon G. Humiston, MD, MPH
  • Writer/Publication Coordinator
    Taryn Chapman, MS
    Courtnay Londo, MA
  • Style and Copy Editor
    Marian Deegan, JD
  • Web Edition Managers
    Arkady Shakhnovich
    Jermaine Royes
  • Contributing Writer
    Laurel H. Wood, MPA
  • Technical Reviewer
    Kayla Ohlde

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