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Immunization Action Coalition
IAC Express 2007
Issue number 680: August 20, 2007
 
Contents of this Issue
Select a title to jump to the article.
  1. CDC responds to NVIC's press release about the safety of the HPV vaccine Gardasil
  2. IAC updates three of its Spanish-language viral hepatitis screening questionnaires
  3. IAC updates patient- and professional-education materials on influenza and hepatitis B
  4. CDC reports on U.S. kindergarteners' vaccination coverage during the 2006-07 school year
  5. For coalitions: IZTA update on influenza vaccine supply and CDC's influenza communication plan scheduled for September 6
 
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 680: August 20, 2007
1.  CDC responds to NVIC's press release about the safety of the HPV vaccine Gardasil

On August 17, CDC's Immunization Safety Office, Office of the Chief Science Officer, posted a document on its website titled "Fast facts that address statements made in a press release by the National Vaccine Information Center on 8/15/07 regarding Gardasil and Guillain-Barre Syndrome (GBS)." Gardasil is the trade name of Merck's human papillomavirus (HPV) vaccine.

CDC's Fast Facts gives health professionals resources for answering patient questions that might arise from the press release issued by the National Vaccine Information Center (NVIC). NVIC is a non-governmental organization that frequently criticizes the use of vaccines and vaccination efforts. In addition to containing statements regarding Gardasil and GBS, NVIC's press release also encouraged CDC to change its recommendations for HPV vaccination.

CDC's Fast Facts document indicates there are no changes to any of the existing HPV vaccination recommendations. The document is reprinted below in its entirety.


Fast facts that address statements made in a press release by the National Vaccine Information Center on 08/15/07 regarding Gardasil and Guillain-Barre Syndrome (GBS).

Fast facts:

THE VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS) is a national program that monitors the safety of vaccines after they are licensed. VAERS is managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS is designed to collect reports of potential adverse events following immunization. VAERS reports can be submitted by anyone. When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event, nor is VAERS designed to calculate absolute or relative risks. Please Note: VAERS defines "serious adverse events" by Code of Federal Regulations as involving hospitalization, death, disability, life threatening illness, or certain other medically important conditions. Also, VAERS data is continuously updated and the number of reports will vary from the date of an analysis.

VAERS REPORTS RELATED TO GARDASIL:
Since the licensure of Gardasil, more than 7 million doses of vaccine have been distributed. As of June 30, 2007, VAERS had received a total of 2,531 reports. Nearly 95% of the reports received to date have been classified as non-serious. The number of serious adverse events reported is less then 6% of the total number of reports received. In comparison, the overall average in VAERS for any serious adverse event ranges from 10%-15%; thus, the percentage of serious reports for Gardasil are less than half of the overall average.

At this time the U.S. does not have a national registry for immunization and vaccination and therefore can not report the total number of persons who have received Gardasil.

CDC'S REVIEW OF VAERS REPORTS CONCERNING GARDASIL AND GBS:
As of June 30 2007, VAERS had received 13 reports concerning GBS after Gardasil. These 13 GBS reports are currently undergoing expert review. Our efforts to date are below:
  • Only 2 meet the case definition of GBS, occurred within six weeks after vaccination, and had received Gardasil alone.
     
  • Six of the 13 reports also involved simultaneous receipt of Menactra vaccine. Current studies are underway to evaluate the small increased risk of GBS, which might be associated with receipt of Menactra vaccine.
     
  • Six of the 13 reports occurred after Gardasil was given alone (without any other vaccine).
     
  • Thirteen reports of GBS are within the numbers of reports that could be expected to occur by chance alone after a vaccination.
     
  • As of June 30 2007, there have been seven deaths reported after Gardasil vaccine. These reports are currently being investigated.

After a careful review of the GBS reports received by VAERS, many appear to have insufficient clinical data. Because GBS occurs at a rate of 1-2/100,000 person years during the second decade of life, it is likely that, some cases will occur after vaccination but will not be due to vaccination. A temporal association does not confirm a causal association. In summary, the number of serious adverse events has been relatively very rare, in the context of more than 7 million doses distributed across the U.S.

Approximately 90% of the reports received by the VAERS regarding Gardasil do not involve co-administration of another vaccine. The recommendation of co-administration is consistent with the General Recommendations of the Advisory Committee on Immunization Practices (ACIP).

Scientists recognize the potential for syncope (fainting) after any medical procedure involving a needle and therefore recommend a 15 minute waiting/observation period after all vaccines. Syncope after vaccination is most common in adolescent and young adults and has been reported after other vaccines. About 50% of young adults experience at least one syncope episode at some point in their lives.

In conclusion, there are no changes to any of the existing HPV recommendations.

ADDITIONAL RESOURCES AND LINKS:
(1) Quadrivalent Human Papillomavirus Vaccine (HPV4): United States Post-licensure Safety Update. Presented by John Iskander, MD, MPH, Immunization Safety Office, Office of the Chief Science Officer, CDC.
http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun07/35-hpv3-iskander.pdf

The PDF can also be found at:
http://www.cdc.gov/vaccines/recs/acip

(2) The Advisory Committee on Immunization Practices (ACIP), Vaccine for Children Program, Vaccine to Prevent Human Papillomavirus (HPV) Infection. The link below is a PDF of the ACIP Resolution No. 6/06-2.
http://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0606hpv.pdf

The PDF can also be found at:
http://www.cdc.gov/vaccines/programs/vfc

(3) CDC Questions and Answers (Qs & As) Concerning the Safety and Efficacy of Gardasil, dated: June 4, 2007. The link list is a PDF with the top 7 Qs & As:
http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/vac-faqs-vacsafe-efficacy.pdf

Additional information and the PDF can also be found at:
http://www.cdc.gov/vaccines/vpd-vac/hpv

(4) Vaccine Testing and the Approval Process: this link will describe vaccine development and testing such as basic research, clinical studies, side effects and adverse reaction. For additional information please visit:
http://www.cdc.gov/vaccines/resdev/test-approve.htm

(5) HPV and HPV Vaccine: Information for Healthcare Providers. This PDF is a fact sheet that provides an overview of HPV including information on Safety and Efficacy. Additional information and the PDF can also be found at: http://www.cdc.gov/std/HPV 

(6) Quadrivalent HPV Vaccine: Efficacy and Provisional Recommendations. Presented by Lauri Markowitz, MD, National Centers for HIV, Viral Hepatitis, STD and TB Prevention, CDC:
http://www.cdc.gov/vaccines/ed/ciinc/archived/hpv/downloads/3-HPV.ppt

Additional information and the PDF can also be found at:
http://www.cdc.gov/vaccines/ed/ciinc

(7) Infectious Diseases in Children: What's Hot in Pediatric ID. Article: Severe adverse events associated with HPV vaccine are rare. August 2007, Volume 20. Number 8: 23-24.

To access the fact sheet from the CDC website, go to:
http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/hpv-gardasil-gbs.pdf

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2 IAC updates three of its Spanish-language viral hepatitis screening questionnaires

IAC recently posted Spanish-language versions of three of its newly updated viral hepatitis screening questionnaires: (1) "Should You Be Vaccinated Against Hepatitis A?" (2) "Should You Be Vaccinated Against Hepatitis B?" and (3) "Should You Be Tested for Hepatitis C?" Following are links to the Spanish- and English-language versions of the three.

(1) To access "Se debe vacunar contra la hepatitis A? Un cuestionario para adultos para determinar si se deben vacunar," go to: http://www.immunize.org/catg.d/p2190-01.pdf

To access "Should You Be Vaccinated Against Hepatitis A? A questionnaire for adults," go to: http://www.immunize.org/catg.d/2190hepa.pdf

(2) To access "Se debe vacunar contra la hepatitis B? Un cuestionario para adultos para determinar si se deben vacunar," go to: http://www.immunize.org/catg.d/p2191-01.pdf

To access "Should You Be Vaccinated Against Hepatitis B? A questionnaire for adults," go to: http://www.immunize.org/catg.d/2191hepb.pdf

(3) To access "Le deben hacer la prueba de la hepatitis C? Un cuestionario para adultos para determinar si necesitan la prueba," go to: http://www.immunize.org/catg.d/p2192-01.pdf

To access "Should You Be Tested for Hepatitis C? A questionnaire for adults," go to: http://www.immunize.org/catg.d/2192hepc.pdf

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3 IAC updates patient- and professional-education materials on influenza and hepatitis B

IAC recently revised four its influenza educational materials and two of its hepatitis B materials. Details follow.

INFLUENZA MATERIALS: Changes were made to the following to reflect CDC's new influenza vaccination recommendations, which were revised in July for the 2007-08 influenza season.

(1) To access the newly revised piece "Give These People Influenza Vaccine!" go to:
http://www.immunize.org/catg.d/p2013.pdf

(2) To access the newly revised piece "Screening Questionnaire for Injectable Influenza Vaccination," go to:
http://www.immunize.org/catg.d/p4066.pdf

(3) To access the newly revised piece "Standing Orders for Administering Influenza Vaccines to Children & Adolescents," go to:
http://www.immunize.org/catg.d/p3074a.pdf

(4) To access the newly revised piece "Standing Orders for Administering Influenza Vaccines to Adults," go to:
http://www.immunize.org/catg.d/p3074.pdf

VIRAL HEPATITIS MATERIALS: Changes were made to the following to reflect CDC's hepatitis B vaccination recommendations, which were revised in December 2005 (children and adolescents) and December 2006 (adults).

(1) To access the newly revised piece "Standing Orders for Administering Hepatitis B Vaccine to Children & Teens," go to:
http://www.immunize.org/catg.d/p3076a.pdf

(2) To access the newly revised piece "Standing Orders for Administering Hepatitis B Vaccine to Adults," go to:
http://www.immunize.org/catg.d/p3076.pdf

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4 CDC reports on U.S. kindergarteners' vaccination coverage during the 2006-07 school year

CDC published "Vaccination Coverage Among Children in Kindergarten--United States, 2006-07 School Year" in the August 17 issue of MMWR. Portions of the article are reprinted below.


Healthy People 2010 objectives include increasing vaccination coverage among children in kindergarten and first grade (objective 14-23). For these children, the target is >=95% vaccination coverage for the following: hepatitis B vaccine; diphtheria and tetanus toxoids and pertussis vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine, or diphtheria and tetanus toxoids vaccine (DTP/DTaP/DT); poliovirus vaccine; measles, mumps, and rubella (MMR) vaccine; and varicella vaccine. To assess progress toward national goals and determine vaccination coverage among children in kindergarten, data were analyzed from reports submitted to CDC by 49 states and the District of Columbia (DC) for the 2006-07 school year. This report summarizes findings from that analysis, which indicated that approximately 75% of states have reached the 2010 objective of at least 95% coverage for all of the vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for children in kindergarten. These results underscore the effectiveness of school-entry requirements in increasing vaccination coverage but highlight a need for more standardized vaccination reporting among states. . . .

Among the reporting states, coverage ranged from 32 (74%) states with >=95% coverage for varicella vaccine to 35 (83%) states with >=95% coverage for hepatitis B vaccine. Although four states do not require or monitor mumps vaccination and one state does not require or monitor rubella vaccination, MMR usually is the vaccine of choice for protection against measles; therefore, children who receive this vaccine are protected against all three diseases. Thirty-five (70%) states reported >=95% coverage for MMR. Thirteen of the reporting states did not meet the 95% coverage target for one or more of the vaccines. . . .

EDITORIAL NOTE:
State laws requiring proof of vaccination at early school entry are key to the U.S. vaccination program and help ensure that no child is unvaccinated. The effectiveness of these laws depends on school nurses, teachers, health department staff members, and others identifying children whose vaccinations are not up to date. The findings from this analysis indicate that approximately 75% of states have reached the 2010 objective of at least 95% coverage for all vaccines recommended for children in kindergarten. The high nationwide coverage indicated in this analysis and other surveys in recent years underscore the success of school-entry requirements in boosting vaccination coverage. Childhood vaccination coverage also is measured nationally among children aged 19-35 months. Higher percentages of children are up to date at kindergarten entry than at younger ages, suggesting that early school-entry laws help maintain high coverage and ensure completion of the vaccine doses recommended for children by ages 4-6 years. . . .


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5632a3.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5632.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html

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5 For coalitions: IZTA update on influenza vaccine supply and CDC's influenza communication plan scheduled for September 6

The Immunization Coalitions Technical Assistance Network (IZTA) conference call on September 6 will provide the latest information on the influenza vaccine supply situation and an overview of influenza vaccine communication, including educational material available to assist coalitions in promoting vaccination in their communities. IZTA is a program of the Center for Health Communication, Academy for Educational Development.

The presenter is Alan Janssen, communication specialist at CDC's National Center for Immunization and Respiratory Diseases.

The September 6 call will be held at 2PM, ET. To register, send an email to izta@aed.org Include this message: "Sign me up for the influenza vaccine update call."

For additional information, or to access earlier programs, go to: http://www.izta.org/confcall.cfm

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Immunization Action Coalition  •  Saint Paul, MN
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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.