[NP-Clinical] CDC Responds to NVIC's press release about the safety
of the
GRETAOB at aol.com
GRETAOB at aol.com
Mon Aug 20 23:55:55 PDT 2007
August 20, 2007
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-iskan
der.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.pd
f
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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