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