Gardasil Links

Gardasil is the vaccine that is marketed to protect girls from some types of HPV that possibly lead to cervical cancer.

Articles:

Gardasil gets pre-qualification from WHO
27 May 2009

Regulatory Affairs

A cervical cancer vaccine from Merck has been granted World Health Organization (WHO) pre-qualification, the first such treatment to do so.

Gardasil can now be procured by the United Nations (UN) Children's Fund and other UN agencies to be used in national immunisation programmes.

The pre-qualification stage aims to ensure the vaccine meets quality, safety and efficacy requirements set out by the WHO.

Margaret McGlynn, president at Merck Vaccines and Infectious Diseases, said the approval is "an important step" to help more people benefit from the advances in technology.

Graca Machel, founder and president of the Foundation for Community Development in Mozambique, said: "WHO pre-qualification of an HPV vaccine signifies a move to help protect young women and improve access to better health care, particularly in the poorest countries."

Earlier this month additional phase-two studies on the Gardasil vaccine were presented, with Merck claiming it protected against HPV 16 infection for an average of eight-and-a-half years.
Source: Hays Pharma
http://www.hayspharma.com/news/regulatory-affairs/gardasil-gets-pre-qualification-from-who/19188076

Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.


Gardasil Good for Older Women and Men, Too, Researchers Say

Gardasil, the cervical cancer vaccine given to millions of American girls and young women, may also prevent cancer-causing genital warts in older women and even men, new company-sponsored research has found.

The vaccine prevents spread of the human papilloma virus (HPV), the most common sexually-transmitted disease in the world. About 20 million people in the United States have the virus, which also is the leading cause of cervical cancer and kills nearly 4,000 women in the U.S. every year and about 300,000 worldwide.

HPV also has been linked to other types of cancers, including penis, anal, neck, and mouth cancers. Overall, between 1998 and 2003, HPV caused about 25,000 cases of cancer in the U.S. alone, according to statistics from the Centers for Disease Control and Prevention.

More than 23 million doses of Gardasil have been distributed worldwide, officials said.
Study Finds Broader Benefits

A new study of Gardasil concluded that the vaccine can prevent infections of the genital wart virus in women between the ages of 24 and 45 who have no history of cervical disease or genital warts. Gardasil also is 90-percent effective in preventing sexually-transmitted warts in men, the study found.

Researchers led by the National Institute of Cancer in Bogota, Columbia tested nearly 2,000 women who received the recommended three doses of Gardasil as well as an equal number of women who were given a series of placebo injections.

After two years, they found that four women who got Gardasil had developed cervical disease or an HPV infection, compared to 41 women in the placebo group. The vaccine was 90-percent effective in preventing HPV infection or cervical disease, the study found.

Gardasil protects against the two most common forms of HPV, which cause about 70 percent of all cases of cervical cancer. It also guards against two HPV strains which cause genital warts.

The vaccine, made by Merck, is approved in the United States for use in girls as young as nine and women up to 26, but vaccinations for women older than 26 have not been approved by the FDA.

Merck funded the Columbian study and has been seeking uses to broaden Gardasil’s approvals in the United States.
Gardasil Linked to Infections, Other Complications

Gardasil, which was FDA-approved in 2006, has been linked to potentially deadly infections and other severe reactions. In April 2009, medical researchers said they have found that women and girls given the series of shots were more likely to contract Guillain-Barre syndrome, a potentially deadly condition in which the body’s immune system attacks the nervous system.

In February 2009, approximately 76,000 doses of Gardasil vaccines were ordered recalled in Spain after two girls there had to be hospitalized after suffering adverse reactions to the vaccine.

In 2008, researchers confirmed at least three severe allergic reactions in girls and young women who had received the shots in Australia.
Proceed With Caution on Gardasil

Given the history of life-threatening complications and adverse reactions to Gardasil documented worldwide, the FDA should act with caution in giving the go-ahead to broader uses of the vaccine in older women and men.

With millions of people already taking the shots to prevent HPV infections and potentially millions more eligible for injections should the wider uses be approved, the potential for widespread problems is there.

Source:
attorneyatlaw.com

http://www.attorneyatlaw.com/2009/06/gardasil-good-for-older-women-and-men-too-researchers-say/



Gardasil again denied approval for women 27-45
By Lewis Krauskopf and Ransdell Pierson, Reuters


U.S. health regulators want longer-term data on the use of Merck & Co's Gardasil cervical cancer vaccine in an older group of women before they will approve the vaccine for those women, the drugmaker says.

U.S. health regulators want longer-term data on the use of Merck & Co's Gardasil cervical cancer vaccine in an older group of women before they will approve the vaccine for those women, the drugmaker says.
Photograph by: AFP/Getty Images

NEW YORK (Reuters) - U.S. health regulators have again withheld approval for the use of Merck & Co Inc's Gardasil cervical cancer vaccine by women aged 27 to 45, asking for longer-term clinical data, the drugmaker said on Friday.

The U.S. Food and Drug Administration recommended Merck submit data when a 48-month study on a test group has been completed. The agency also withheld approval in June on Merck's initial application that was based on data collected through an average of 24 months.

Merck shares fell nearly 3 percent in midday trading.

Gardasil, one of Merck's most successful newer products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26.

It works by preventing infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.

"Gardasil's efficacy drops sharply once females have been exposed to HPV and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application," Sanford Bernstein analyst Tim Anderson said in a research note.

Moreover, because effectiveness is naturally lower in older females, Merck could have difficulty convincing insurers to cover Gardasil in that group should it be approved for them, Anderson added.

The FDA letter does not affect the use of the drug in the approved age group, or Merck's recently filed application to expand use to males, the company said. By preventing infection among males, the hope is they would not be able to spread the virus to females through sexual contact.

Anderson expressed uncertainty about the FDA's eventual decision on Gardasil's use in males and about its sales potential in that population.

Merck on Friday also stood by its 2009 sales and earnings targets. It said it would update other elements of its forecast in a February 3 earnings conference call. In December, the company forecast Gardasil sales of $1.4 billion to $1.6 billion for 2009.

Global sales of the vaccine fell 4 percent to $401 million in the third quarter. Many girls and women in the approved age group have already taken the vaccine and it is now facing competition overseas from GlaxoSmithKline Plc's Cervarix.

Merck shares were down 79 cents to $28.57 in midday trading on the New York Stock Exchange.

(Reporting by Lewis Krauskopf and Ransdell Pierson, editing by John Wallace and Andre Grenon)
© Copyright (c) Reuters

Source: The Vancouver Sun
http://www.vancouversun.com/Health/Gardasil+again+denied+approval+women/1159546/story.html

Gardasil Warnings to Include “Seizure-Like” Reactions
http://ecochildsplay.com/2009/06/16/gardasil-warnings-to-include-seizure-like-reactions/


Information Pertaining to Labeling Revision for Gardasil

SOURCE: FDA [FOOD AND DRUG ADMINISTRATION] United States
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm
Reminder to HealthCare Providers: 15-minute Observation Period Needed After Vaccination

On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.

As with all vaccines, FDA closely monitors the safety of Gardasil. Syncope (fainting) has been in Gardasil’s labeling for both the healthcare provider and the patient since October 2007; however, FDA and the Centers for Disease Control and Prevention (CDC) continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Therefore, FDA requested the manufacturer, Merck and Co., Inc., to add this information to the Warnings and Precautions section of the label, so that it is more prominent, and reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation, or in response to pain. Jerking movements, loss of bladder control, and other signs that resemble epileptic seizures may occur with fainting, but do not mean that the person is having epilepsy. New information in the Warnings and Precautions section alerts healthcare providers that tonic-clonic (jerking) movements and seizure-like activity can occur with fainting. Syncope and its associated signs and symptoms generally last only a short time (seconds to minutes) and resolve when the patient is placed in a position, such as lying down, to restore adequate blood flow to the brain.

A Morbidity and Mortality Weekly Report published in May 2008 recommends that all providers administering vaccinations should be aware of the potential for syncope after vaccination and should take appropriate measures to prevent potential injuries. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning this particular side effect are needed for other adolescent and adult vaccines. FDA and CDC are also in the process of reviewing the Vaccine Information Statements (VISs) to include syncope. These information sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal Law requires that VISs be handed out whenever (before each dose) certain vaccinations are given.

Key Facts:

* Healthcare providers and consumers should be aware that syncope (fainting) may occur following vaccination with Gardasil, sometimes resulting in falling and traumatic injuries. These falls and injuries are preventable by having Gardasil recipients remain seated or lying down for 15 minutes following vaccination, closely observing them, and watching for the following warning signs and symptoms: paleness, sweating, dizziness, ringing in ears or vision changes, which generally occur before fainting. If an individual faints, and especially if seizure-like activity occurs, the individual should be placed in a position, such as lying down to help restore blood flow to the brain.
* FDA has received reports to the Vaccine Adverse Event Reporting System (VAERS) of syncope, as well as, syncope with tonic-clonic (jerking) movements and seizure-like activity that occurred after Gardasil and other vaccinations. Of all of the reports in VAERS pertaining to Gardasil, approximately 13% describe syncope. The percentage is similar to reports of syncope for other adolescent vaccines.

The VAERS is a national vaccine safety surveillance program co-sponsored by the FDA and the CDC. The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines.

In 2007, FDA and CDC did a comprehensive review of VAERS reports of syncope and related medical charts after adolescent vaccination. The review found that 30-40% of adolescent syncope reports described signs of jerking or other seizure-like activity, approximately 20% described traumatic injury, and 95% occurred within 15 minutes of vaccination.

Since syncope was added to the label in 2007, we continue to receive a consistent number of reports of syncope and traumatic injuries resulting from it. Because the number of reports has not declined, this reminder to healthcare providers emphasizes that preventive measures are warranted.
* Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation or in response to pain and the following may occur: jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.
* Gardasil is an important tool for the prevention of cervical, vulvar and vaginal cancers and genital warts that will benefit the health of millions of women. HPV types 16 and 18 cause approximately 70 percent of cervical cancers, and HPV types 6 and 11 cause approximately 90 percent of genital warts. According to the National Cancer Institute, in 2009 there will be approximately 11,000 new cases of cervical cancer and 4,000 deaths in the United States.
* Gardasil will not treat existing diseases caused by HPV types contained in the vaccine and it is important that vaccination with Gardasil occurs before exposure to HPV infection. Females who receive Gardasil should continue to undergo regular pap tests for cervical cancer screening.
* Since it was licensed, FDA and CDC have been closely monitoring the safety of Gardasil.
Based on ongoing assessments of vaccine safety information gathered from various surveillance tools, FDA and CDC continue to find that Gardasil is a safe and effective vaccine, and that its benefits continue to outweigh its risks. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning syncope are needed for other adolescent and adult vaccines.

Page Last Updated: 06/18/2009


Ideally, vaccine should be administered before potential exposure to HPV through sexual activity; however, females who are sexually active should still be vaccinated consistent with age-based recommendations. Sexually active females who have not been infected with any of the four HPV vaccine types receive the full benefit of the vaccination. Vaccination is less beneficial for females who have already been infected with one or more of the HPV vaccine types.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5753a6.htm




HPV vaccine's suspected side effects cause concern; CDC says drug is safe
12:00 AM CDT on Friday, June 6, 2008

By JESSICA MEYERS / The Dallas Morning News
jmeyers@dallasnews.com

Katherine Kimzey started suffering debilitating headaches, fainting spells and arthritis-like stiffness last November.

Six weeks later, the 14-year-old Dallas resident became so dizzy she could barely walk. She was hospitalized and missed three weeks of school.

Then, she had a seizure. For weeks, she bounced back and forth between specialists and was eventually diagnosed with epilepsy.

Katherine's mother, Michelle Kimzey, now believes her daughter's symptoms were caused by a new vaccine that was supposed to protect her against cervical cancer.

The symptoms started not long after Katherine had her second shot late last year, she said. And they mirrored many of the 5,000 reports filed by the public through a national database that monitors the safety of vaccines after they are licensed.

"When you read everybody's stories, they're too similar not to be related," Mrs. Kimzey said.

But officials with the Centers for Disease Control and Prevention and doctors nationwide said such concerns about the drug are unfounded and most significant side effects reported are unrelated to the vaccine.

"The safety of the vaccine is being very closely monitored," said John Iskander, acting director for immunization safety at the CDC, which runs the database along with the Food and Drug Administration.

Fainting, he said, has been the strongest negative response to the vaccine.

"There certainly have been high-profile suspected side effects, some reports of deaths," he said, "but those have been investigated and they don't appear to have been causally related."

The recommendations have not changed and the vaccine will remain available, he said.

Jennifer Allen, a spokeswoman for New Jersey-based Merck & Co.'s vaccine division, which makes Gardasil, said Thursday that the company conducted clinical trials for 10 years and that it remains confident in its product.

But this hasn't assuaged Mrs. Kimzey, 41. And Katherine has refused to get her third and final dose of the vaccine.

Gardasil was approved by the Food and Drug Administration two years ago for girls between ages 9 and 26. It protects against sexually transmitted diseases caused by the human papillomavirus, or HPV, responsible for 70 percent of cervical cancers and 90 percent of genital warts. Females are encouraged to get the vaccine before they become sexually active.

Three shots are given over a six-month period. The company said 16 million doses have been administered since its approval. And it lists nausea, vomiting and pain following the shot among the side effects.

The HPV vaccine has generated debate across the country and in Texas. Gov. Rick Perry issued an executive order in February 2007 requiring that all sixth-grade girls get the HPV shot. But angry parents and conservative groups fought the mandate, fearing it condoned premarital sex and took away parental rights. The Legislature defeated the order last April.

The National Vaccine Information Center heralded the decision, saying that testing of the vaccine was not extensive enough in girls under 12. The nonprofit center had already started warning about the possibility of adverse reactions such as extreme fatigue, arthritis and loss of consciousness.

Barbara Loe Fisher, co-founder and president of the center, said she's frustrated that the CDC has "assumed safety" for Gardasil, which has been tested only in conjunction with the vaccine for Hepatitis B.

Today, girls often receive the Gardasil shot at the same time as a meningitis vaccine and another new booster that immunizes against tetanus, diphtheria and pertussis.

The FDA has approved all the vaccines separately, but studies on administering them together are still ongoing.

"Not only was Gardasil put on the fast track and licensed quickly," said Ms. Fisher, "but to say safety is assumed and you can give any vaccine with it is even more shocking."

Joseph Bocchini, chairman of the Committee on Infectious Diseases for the American Academy of Pediatrics, says there's enough evidence to support mixing the drugs and not enough adverse reactions to stop it.

"From the data, we already know [the vaccines] would not be expected to interfere with each other in terms of antibody or safety," said Dr. Bocchini. "If we look at the number of doses given vs. the reports, it's very clear that there are significant benefits that far outweigh potential risks at this time."

Dr. Bocchini cautioned that reactions that do not occur immediately, like seizures, may actually be caused by something else. So far, he said, there have not been enough verifiable reports of extreme side effects through the Vaccine Adverse Event Reporting System, or VAERS, to generate a study.

Dallas County's Health and Human Services officials said they have received no reports of severe reactions to the vaccine.

The Texas Department of Health and Human Services said it had 210 reports of reactions to Gardasil last year, eight of which required hospitalization.

But officials said this is not an uncommon number for a vaccine. Dr. Jennifer Walsh said she will continue to encourage use of the vaccine where she works, the Adolescent Medical Clinic at Children's Medical Center Dallas.

"I'm still following the standard guidelines," Dr. Walsh said. "I don't have any worries at this point."

Leave Comment

Posted by chicken in the house | 3 months ago

okay sorry about my screen name thats the only one i could think off but my name is sarah not "chicken in the house" lol,anyaway i'm 12 years old and i had the hpv vaccnetaions and i have been fainting 4 times the docter said that he is goign to scan my brain but lots off girls are having this hpv shots and been having bad reaction too it,but if we all think about it is the goverment falut because he brought this vaccentions in to our lifes however he would not tell us the long terms side effect and the short term side effects but the only thing that he will do is to persuade us as a commuinty and i'm really worried that i might have epilepsy.


Posted by bbreier | 10 months ago

My daughter is 16 yrs old and on Feb 27, 2008 had her first HPV vaccine and the second one April 24, 08. On June 14-08 I heard my dog barking in the living room I went to see what he was barking at and I found my daughter lying on the carpet having a seizure. At the time this was happening I did not know she was having a seizure because she doesn’t have a history of seizure problems. I thought my daughter was dying in my arms of course I dialed 911 and she was taken to the Emergency room. We have under gone several tests CAT scan, EEG, MRI, spinal tap, blood work and currently seeing a neurologist. The test have came back all negative and now she has to take medicine for epilepsy. The first medicine the ER put her on was phenytoin sodium. Now she is taking Keppra., I had ask her primary doctor if there could be some connection to having taking the HPV vaccine her answer was that there has been no evidence or research to prove that the HPV vaccine can cause seizures. The doctor also said she probably has epilepsy. Wow this has been my daughter’s doctor since she was 5 yrs old. My daughter Sarah Breier is an outgoing teenager who has plans to graduate from high school and go on to a 4 year college. She is active in sports and plays the violin. I would definitely like to know why the medical field will not even consider that the HPV vaccine may have cause the complications.

Source: Dallas News
http://www.dallasnews.com/sharedcontent/dws/news/localnews/stories/DN-vaccine_06met.ART.North.Edition1.46ef875.html

Merck admits the vaccine Gardasil, can cause faints and seizures.
http://www.americanchronicle.com/articles/view/105999


Wiggins’ HPV vaccine bill approved
Redwood Times
Posted: 06/18/2009 03:11:37 PM PDT
The Assembly Health Committee has approved SB 158 by a margin of 10 to 6. This legislation, authored by State Senator Patricia Wiggins, requires health insurers and health maintenance organizations to cover the costs of human papillomavirus (HPV) vaccine upon the referral of a doctor.
http://www.redwoodtimes.com/health/ci_12621017

Patricia Wiggins
In 2000, as an Assemblywoman, Wiggins founded the Legislature's Smart Growth Caucus (www.assembly.ca.gov/sgc)



The outburst occurred as Jones, 46, testified at an informational hearing on how California will cut global warming emissions. Jones, who is African American, said he went to urge lawmakers to consider minority communities when drafting those regulations.

"Our communities are the ones who suffer more than any other communities - the poor and the underrepresented...," Jones said. "It is important to have our perspective."

But after less than two minutes of speaking -- and before he could finish -- Wiggins blurted out, "Excuse me, but I think your arguments are bull----."
http://www.sacbee.com/static/weblogs/capitolalertlatest/014491.html

Gardasil Website Patient Information
Source: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
Source Page: http://www.gardasil.com/gardasil-product-information/index.html
This site is intended only for residents of the United States, its territories, and Puerto Rico.

9883611
1
USPPI
Patient Information about
GARDASIL® (pronounced “gard-Ah-sill”)
Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine,
Recombinant]
Read this information with care before getting GARDASIL∗. You (the person getting GARDASIL) will
need 3 doses of the vaccine. It is important to read this leaflet when you get each dose. This leaflet does
not take the place of talking with your health care provider about GARDASIL.
What is GARDASIL?
GARDASIL is a vaccine (injection/shot) that is used for girls and women 9 through 26 years of age to help
protect against the following diseases caused by Human Papillomavirus (HPV):
• Cervical cancer
• Vulvar and vaginal cancers
• Genital warts
• Abnormal and precancerous cervical, vaginal, and vulvar lesions
o The diseases listed above have many causes, and GARDASIL only protects against
diseases caused by certain kinds of HPV (called Type 6, Type 11, Type 16, and Type 18).
Most of the time, these 4 types of HPV are responsible for the diseases listed above.
o GARDASIL cannot protect you from a disease that is caused by other types of HPV, other
viruses, or bacteria.
o GARDASIL does not treat HPV infection.
o You cannot get HPV or any of the above diseases from GARDASIL.
What important information about GARDASIL should I know?
• You should continue to get routine cervical cancer screening.
• GARDASIL may not fully protect everyone who gets the vaccine.
• GARDASIL will not protect against HPV types that you already have.
• You may still benefit from GARDASIL if you do not already have all four vaccine types of HPV.
Who should not get GARDASIL?
You should not get GARDASIL if you have, or have had:
• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate
80.
What should I tell my health care provider before getting GARDASIL?
Tell your health care provider if you:
• are pregnant or planning to get pregnant. GARDASIL is not recommended for use in pregnant
women.
• have immune problems, like HIV infection, cancer, or you take medicines that affect your immune
system.
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of GARDASIL.
• take any medicines, even those you can buy over the counter.
Your health care provider will help decide if you should get the vaccine.
How is GARDASIL given?
∗ Registered trademark of MERCK & CO., Inc. Whitehouse Station, NJ 08889, USA
COPYRIGHT © 2006, 2008 MERCK & CO., Inc.
All rights reserved
GARDASIL®
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 9883611
2
GARDASIL is a shot that is usually given in the arm muscle. You will need 3 shots given on the following
schedule:
• Dose 1: at a date you and your health care provider choose.
• Dose 2: 2 months after Dose 1.
• Dose 3: 6 months after Dose 1.
Fainting sometimes happens after getting GARDASIL. For this reason, your health care provider may ask
you to sit or lie down for 15 minutes after you get GARDASIL.
Sometimes fainting has been accompanied by falling with injury, as well as shaking or stiffening and other
seizure-like activity. This may require evaluation or treatment by your health care provider.
Make sure that you get all 3 doses on time so that you get the best protection. If you miss a dose, talk to
your health care provider.
What are the possible side effects of GARDASIL?
The most common side effects with GARDASIL are:
• pain, swelling, itching, bruising, and redness at the injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting
Tell your health care provider if you have any of the following problems because these may be signs of an
allergic reaction:
• difficulty breathing
• wheezing (bronchospasm)
• hives
• rash
Tell your health care provider if you have:
• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness or weakness
• chills
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache
Contact your health care provider right away if you get any symptoms that concern you, even several
months after getting the vaccine.
For a more complete list of side effects, ask your health care provider.
GARDASIL®
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 9883611
3
What are the ingredients in GARDASIL?
The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate
sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.
This leaflet is a summary of information about GARDASIL. If you would like more information, please talk
to your health care provider or visit www.gardasil.com.
Manufactured and Distributed by: MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA
Issued June 2009