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HPV Vaccine (Gardasil) – severe reactions

HPV (Human Papillomavirus) is a common infection.
In the US, approximately 20 million people are infected with HPV and
approximately 80% of all US women will have acquired at least one strain
of HPV by age 50.

For most people, HPV goes away on its own. However,
some high-risk types of HPV (if unrecognized and untreated) can lead to
cervical cancer. Cervical cancer is the second most common cause of
cancer-related deaths in women worldwide. Gardasil helps protect against
4 HPV types (6, 11, 16 and 18) that causes 70% of cervical cancer cases
and 90% of cases of genital warts. All 4 types cause a large number of
“abnormal” Pap test results and low grade cervical lesions.

Study results showed that Gardasil provided significant
protection for women not previously exposed (and who remained free of
HPV infection until all 3 doses of vaccine given) to HPV types targeted
by the vaccine.
In studies with an average follow-up of 3
years, Gardasil provided 100 percent protection to low-medium grade
cervical pre-cancers and genital warts from HPV types in vaccine (HPV 6,
11, 16, and 18) and 98 percent protection to high-grade pre-cancers
associated with HPV 16 and 18.

Gardasil was shown to have some efficacy in women already
infected with HPV as well as in women with HPV-related disease.

Gardasil reduced the rate of vaginal/vulvar lesions and genital warts
caused by vaccine or other HPV types by 34 percent as compared to
placebo. Additionally, Gardasil reduced the rate of pre-cancer cervical
dysplasia caused by vaccine or other HPV types by 17%. In summary,
Gardasil did not change the course of pre-existing HPV infections.
However, over the 3 years that study participants were followed, lesions
caused by new infections with vaccine HPV types were
observed in the placebo group but not in the vaccine
group.

After 10 years of clinical trials, Gardasil was approved by
the FDA on June 8, 2006.
Since its FDA approval, more than 26
million doses of Gardasil have been distributed worldwide (16 million of
these doses in the US alone).

Vaccine related adverse experiences in clinical trials were
observed at a frequency of 1 percent (study size of 25,000 women).

The reported experiences (vaccine recipient vs. Placebo recipient)
were pain at injection site (83.9% vs. 75.4%),
localized swelling at injection site (25.4% vs. 15.8%),
redness at injection site (24.6% vs. 18.4%), nausea
(4.2 % vs. 4.1%), itching (3.1% vs. 2.8%) and dizziness
(2.8% vs. 2.6%). Since Gardasil’s FDA approval in 2006, the only
additional vaccine caused adverse events were vomiting and
fainting
.

Recently, several National News sources have reported on new
potential vaccine-related adverse events associated with Gardasil.

Many of these are events that could be seen in the general population,
even in the absence of vaccination. Adverse experience reports describe an event that
occurred after vaccination and does not necessarily mean that the
vaccine caused or contributed to the event.
Recent
reports claiming vaccine-related death and paralysis have been evaluated
by Merck (producer of Gardasil), the CDC and the Vaccine Advisory
Committee. These reports were not found to be causally-related to the
vaccine. When officials look at these reports of adverse events, they
look for patterns. To date, the CDC reports that the data continues to
confirm the safety and efficacy of Gardasil. FDA officials have stated
that no new safety signals were observed in the adverse events other
than fainting (which has recently been added to package insert and
patient information sheets). Additionally CDC officials have reported
that as of June 2008, only 5,000 reports have been filed by the public
through the CDC and FDA Vaccine-related adverse event databases that
monitor the safety of vaccines after they are licensed. CDC officials
(June 6 Dallas Morning News) stated that safety concerns over Gardasil
are unfounded and reports of serious adverse events are unrelated to the
vaccine. John Iskander (acting Director of the Immunization Safety
Office at the CDC) stated that “safety of vaccines is being very closely
monitored”, adding that fainting has been the strongest negative
response to Gardasil. “There certainly have been high-profile suspected
side-effects, some reported deaths'” Iskander said, adding that those
reports “have been investigated, and they don’t appear to have been
causally related.” Additionally, Joseph Bocchini (Chair of the
Committee on Infectious Disease for the American Academy of Pediatrics)
states that “if we look at the number of doses given versus reports of
adverse events, it’s very clear that there are significant benefits that
outweigh potential risks at this time.” The CDC’s as well as AAP’s
recommendations have not been changed and the vaccine will remain
available.

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