Gardasil 9 (human papillomavirus 9-valent vaccine)

What is Gardasil 9?
Gardasil 9 is a vaccine that’s used to prevent certain diseases caused by human papillomavirus (HPV).
human papillomavirus (HPV)
HPV is a virus that can cause very serious conditions such as cervical, vulvar, vaginal, anal, and certain head and neck cancers. It can also cause precancerous spots to form in those areas. In addition to cancer and precancerous spots, HPV can also cause genital warts.
cervical
vulvar
vaginal
anal
head and neck
genital warts
Gardasil 9 is approved for use in children and adults ages 9 through 45 years old. The vaccine is usually injected into the muscle in your upper arm. It can be given as two or three shots over the course of 6 to 12 months.
The Food and Drug Administration (FDA) has approved Gardasil 9 to protect against disease caused by the following HPV strains: types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
These HPV strains are known to cause specific cancers or conditions.
Gardasil 9 is FDA-approved to prevent the following conditions that are caused by HPV in females:*
cervical precancer or cancer
vulvar precancer or cancer
vaginal precancer or cancer
anal precancer or cancer
certain head and neck cancers
genital warts
Gardasil 9 is also FDA-approved to prevent the following conditions that are caused by HPV in males:*
anal precancer or cancer
certain head and neck cancers
genital warts
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
The effectiveness of Gardasil 9 in preventing HPV-related conditions was found in several clinical trials.
The effectiveness of Gardasil 9 vaccine was tested in females ages 16 through 26 years old. In this study, 6,016 females received Gardasil 9 and 6,017 females received Gardasil. (Gardasil is a now-discontinued vaccine that protected against four strains of HPV.) In the Gardasil 9 group, the vaccine was 96.7% effective at preventing abnormal changes or cancer in the cervix, vulva, or vagina.
study
This study looked at HPV types 31, 33, 45, 52, and 58. These are the HPV types not prevented by the Gardasil vaccine. Only one female who received Gardasil 9 had an abnormal change or cancer in the cervix, vulva, or vagina. In comparison, 30 females who received the Gardasil vaccine (which doesn’t protect against these types of HPV) had abnormal changes or cancer in the cervix, vulva, or vagina.
For more information on the vaccine’s effectiveness, including its effectiveness in males and for other conditions, see the “Gardasil 9 uses” section.
Gardasil 9 uses
Gardasil 9 uses
The Food and Drug Administration (FDA) approves vaccines such as Gardasil 9 to prevent certain conditions.
Gardasil 9 is FDA-approved to prevent several types of cancers that can be caused by the human papillomavirus (HPV). HPV is spread by vaginal, anal, or oral sex with someone who has the virus. Even if a person doesn’t show any symptoms, they may still be infected with HPV.
human papillomavirus (HPV)
According to the Centers for Disease Control and Prevention (CDC), HPV is the most common sexually transmitted infection.
Centers for Disease Control and Prevention (CDC)
There are more than 100 types of HPV that can cause problems such as genital warts or cancer. Gardasil 9 protects against nine types. The vaccine contains proteins that are similar to each of these nine types of HPV.
100 types
genital warts
The types of HPV that cause cancer are different from the types of HPV that cause genital warts. Gardasil 9 protects against HPV-related anal cancer and head and neck cancers in males and females.* It also protects against the following types of HPV-related cancer in females:
head and neck cancers
cervical cancer
vulvar cancer
vaginal cancer
These cancers can be caused by HPV types 16, 18, 31, 33, 45, 52, and 58. After getting the vaccine, you’d be protected from all of these types.
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
The effectiveness of Gardasil 9 vaccine was tested in females* ages 16 through 26 years old. In this study, 6,016 females received Gardasil 9 and 6,017 females received Gardasil. (Gardasil is a now-discontinued vaccine that protected against four strains of HPV.) In the Gardasil 9 group, the vaccine was 96.7% effective at preventing abnormal changes or cancer in the cervix, vulva, or vagina.
study
This study looked at HPV types 31, 33, 45, 52, and 58. These are the HPV types not prevented by the Gardasil vaccine. Only one female who received Gardasil 9 had an abnormal change or cancer in the cervix, vulva, or vagina. In comparison, 30 females who received the Gardasil vaccine (which doesn’t protect against these types of HPV) had abnormal changes or cancer in the cervix, vulva, or vagina.
For two HPV types (16 and 18), clinical studies of Gardasil were used to show the effectiveness of Gardasil 9. The Gardasil vaccine and Gardasil 9 vaccine each protect against these types of HPV. In the Gardasil clinical studies, more than 24,000 people received Gardasil, and a similar number received a placebo (an injection with no vaccine). Gardasil was found to be effective in preventing HPV-related abnormal changes or cancer in the cervix, vulva, or vagina.
clinical studies
Based on results of the studies described above, Gardasil 9 is also considered effective in the following age groups:
males* ages 9 through 45 years
females ages 9 through 15 years
females ages 27 through 45 years
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
Gardasil 9 is approved to prevent genital warts caused by HPV. (HPV is not the only cause of genital warts.)
For this purpose, clinical studies of the now-discontinued Gardasil vaccine were used to show the effectiveness of Gardasil 9. These studies showed the vaccine provided protection against HPV types 6 and 11.
In clinical trials, Gardasil was 99% effective at preventing genital warts caused by HPV in females ages 16 through 26 years old. In males ages 16 through 26 years old, the vaccine was about 89% effective in preventing genital warts caused by HPV.
clinical trials
In females ages 27 through 45 years old, Gardasil was between 87.7% and 95.0% effective in preventing genital warts caused by HPV.
In males and females ages 9 through 15 years, studies looked at genital wart infections that occurred after vaccination and lasted for at least 1 year. No cases were observed in this age group after vaccination with Gardasil.
In males ages 27 through 45 years, studies looked at whether Gardasil triggered a response from the immune system that was strong enough to protect against genital warts. Gardasil 9 was found to stimulate a strong immune response in this age group.
immune system
Gardasil 9 is FDA-approved to prevent precancerous growths or abnormal lesions caused by HPV.
HPV can cause abnormal changes in your cervix, vulva, vagina, or anus. Some of these changes are called neoplasia, and they can lead to cancer in some people.
By getting the Gardasil 9 vaccine, you can protect yourself against some of the HPV types that may cause these changes.
Clinical trials showed the effectiveness of the Gardasil 9 vaccine at preventing certain abnormal growths or changes caused by HPV.
Clinical trials
In one study, Gardasil 9 was more than 96% effective at preventing cervical intraepithelial neoplasia (abnormal cell growth in the lining of your cervix) or adenocarcinoma (cancer in your gland cells) caused by HPV types 31, 33, 45, 52 or 58. These are the HPV types whose effects are not prevented by the now-discontinued Gardasil vaccine.
adenocarcinoma
In the study, 5,948 females received the Gardasil 9 vaccine. In this group, there was one case of cervical intraepithelial neoplasia or adenocarcinoma. In comparison, in 5,943 females who received the original Gardasil vaccine, there were 27 cases of cervical intraepithelial neoplasia or adenocarcinoma.
Other studies looked at Gardasil to show the effectiveness of Gardasil 9. This was done because the Gardasil vaccine and Gardasil 9 vaccine both protect against the four types of HPV covered in the studies: 6, 11, 16, and 18.
In these clinical studies, more than 24,000 people received Gardasil, and a similar number received a placebo (an injection with no vaccine). Gardasil was found to be effective in preventing HPV-related precancerous or abnormal lesions caused by those four types of HPV.
clinical studies
Because of these results, Gardasil 9 is considered effective for preventing them as well.
Gardasil 9 is approved for use in children ages 9 years and older. The CDC recommends the Gardasil 9 vaccine for children ages 11 or 12 years old. However, the CDC states that some people may benefit from getting the vaccine as early as age 9.
recommends
Vaccinating children at a young age helps make sure they’re protected against the types of HPV that Gardasil prevents before they become sexually active.
According to the CDC, HPV is the most common sexually transmitted infection. By immunizing your child, they’ll be protected from HPV-related changes in the cervix, vagina, vulva, anus, and head and neck tissues. They’ll also be protected from genital warts caused by the types of HPV prevented by the vaccine.
CDC
Talk with your child’s doctor about their risk for HPV. Together, you can decide when it’s right to give the vaccine to your child.
Gardasil 9 generic or biosimilar
Gardasil 9 is a biologic drug that’s available only as a brand-name vaccine. It’s not currently available in biosimilar form.
Gardasil 9 is considered a biologic because it’s made of proteins that are similar to the human papillomavirus (HPV).
human papillomavirus (HPV)
Drugs made from chemicals can have generic forms, which are exact copies of the active drug in the brand-name drug. Biologics aren’t made from chemicals and can’t be copied exactly. So, instead of generics, biologics have biosimilars.
generic forms
Gardasil 9 side effects
Gardasil 9 can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Gardasil 9. These lists do not include all possible side effects.
For more information on the possible side effects of Gardasil 9, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.
Note: The Food and Drug Association (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Gardasil 9, you can do so through MedWatch.
MedWatch
The more common side effects of Gardasil 9 can include:
pain, swelling, or redness at the injection site (see “Side effect details” below)
bruising, bleeding, itching, or a lump at the injection site
headache
fever
diarrhea
dizziness
feeling tired
nausea
sore throat
abdominal (belly) pain
Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects from Gardasil 9 aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms, described in more detail under “Side effect details” below, can include the following:
allergic reaction
fainting
Side effects that occurred in children were very similar to those seen in adults. The most common side effects in children include:
pain, swelling and redness at the injection site
fever
headache
nausea
dizziness
mouth pain
You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.
As with most drugs, some people can have an allergic reaction after taking Gardasil 9. Symptoms of a mild allergic reaction can include:
skin rash
itchiness
flushing (warmth and redness in your skin)
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
swelling under your skin, typically in your eyelids, lips, hands, or feet
swelling of your tongue, mouth, or throat
trouble breathing
rash or hives
Gardasil 9 contains yeast. If you have a severe allergy to yeast, you should not get the Gardasil 9 vaccine.
Call your doctor right away if you have a severe allergic reaction to Gardasil 9. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.
After you get the Gardasil 9 vaccine, you may have some pain, swelling, or redness at the injection site.
Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” below refers to sex assigned at birth.
Sex and gender
In females
In clinical trials in females ages 9 through 15 years old receiving their first dose of Gardasil 9, 71.7% had injection site pain. Swelling at the injection site occurred in about 14% of females receiving a Gardasil 9 vaccine for the first time. Redness at the injection site occurred in about 7% of females receiving their first dose of the Gardasil 9 vaccine.
clinical trials
With the second and third doses, the percentage of people having injection site pain was about the same as with the first dose. However, redness and swelling at the injection site seemed to happen more often with each dose.
Females ages 16 through 26 years old had similar rates of injection site reactions (including pain, redness, and swelling) as females ages 9 through 15 years old.
In males
In clinical studies, males receiving Gardasil 9 reported similar rates of injection site reactions as females. This includes injection site pain, redness, and swelling.
clinical studies
When given with other vaccines
Swelling at the injection site was more common in people getting Gardasil 9 at the same time as Menactra (meningococcal vaccine) and Adacel (which protects against tetanus, diphtheria, and whooping cough).
diphtheria
whooping cough
Swelling occurred in 14.4% of people who received Menactra, Adacel, and Gardasil 9. This is compared to 9.4% of people who only received Gardasil 9.
After getting the Gardasil 9 vaccine, you may experience dizziness. You may even faint. If you’re standing up when you faint, you can fall and get hurt.
It’s important to tell your doctor or pharmacist if you feel dizzy after getting the Gardasil 9 vaccine. They can help you elevate your feet and lie down so that if you do pass out, you won’t get hurt.
Your doctor or pharmacist may monitor you for 15 minutes after your vaccine to make sure you feel all right.
In some cases, it’s possible to have seizure-like movements after getting the Gardasil 9 vaccine. It’s not clear why this happens. Usually, this involves jerking motions that only last for a short period. Often, lying down and elevating your feet is all that’s needed to make the jerking motions stop.
If you faint with your first dose of Gardasil 9, tell your doctor or pharmacist when receiving your next dose. This way, they can have you lie down and elevate your legs while you get your dose. This could help prevent you from fainting again.
Gardasil 9 safety
Gardasil 9 has gone through years of testing to determine that it’s a safe and effective vaccine. Even since Gardasil 9 became available, studies continue to monitor the safety of the vaccine.
According to the Centers for Disease Control and Prevention (CDC), side effects haven’t occurred more often than expected. The only exception is fainting, which can sometimes be prevented if the person lies down and raises their feet while getting the vaccine.
Centers for Disease Control and Prevention (CDC)
About 28 million doses of Gardasil 9 were given in the United States from 2014 to 2017. During that time, the Food and Drug Administration (FDA) and CDC received about 7,200 reports of side effects. (The reports come from the vaccine’s manufacturer, healthcare professionals, and the public.) Only 3% of those side effects were considered serious. Serious side effects include those which lead to hospitalization or serious injury. You can learn more about these side effects on the CDC’s website.
28 million doses
CDC’s website
There have been some reports of death in people who have received a Gardasil 9 vaccine. However, reports of death mean that the person died after getting the vaccine, but not necessarily that the death was due to the vaccine itself. None of the deaths reported were found to have been caused by the Gardasil 9 vaccine.
reports
According to the CDC, from December 2014 through December 2017, there were seven reports of death after a Gardasil 9 vaccine. During this time, about 28 million doses of Gardasil 9 were administered.
CDC
After a review of each individual case of death, the CDC determined that there was no link between the deaths that occurred and the Gardasil 9 vaccines.
Vaccine safety monitoring occurs with each vaccine that is released onto the market. There is a vaccine reporting system in place to collect information about any side effects that you may experience from a vaccine. This system is called Vaccine Adverse Event Reporting System (VAERS) and is accessible to patients, pharmacists, and doctors. If you experience a side effect that you believe is from a vaccine, you should report it to VAERS through the website.
Vaccine Adverse Event Reporting System (VAERS)
VAERS is run by the CDC and the FDA. These organizations can look into any reported cases more in depth and determine how often a reaction may occur. If a lot of adverse reactions are reported, changes may be made to a vaccine, or warning labels may be added.
As with drugs, call 911 if you have a side effect from a vaccine that feels life threatening or if you think you’re having a medical emergency.
If you have questions about the safety of Gardasil 9, talk with your doctor or pharmacist. They can help explain the benefits of vaccines, and help you understand any risks.
Gardasil 9 for boys and men
Gardasil 9 is best known for preventing cervical cancer in females.* However, human papillomavirus (HPV), the virus that Gardasil protects against, can also affect males.*
human papillomavirus (HPV)
HPV can cause anal and certain head and neck cancers as well as genital warts in males or females.
anal
head and neck
genital warts
In males, Gardasil 9 is approved to prevent certain types of anal, head, and neck cancers, and genital warts that can be caused by HPV.
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
Gardasil 9 dosage
The Gardasil 9 dosage your doctor prescribes will depend on several factors. These include:
your age
other risk factors you may have
The following information describes vaccine schedules that are commonly used or recommended. However, be sure to get Gardasil 9 as your doctor recommends for you. Your doctor will determine the best time to get the vaccine and the best schedule to fit your needs.
Typically, your doctor or pharmacist will give you the vaccine. They will also tell you when to come back for your next dose or doses. It’s important to complete the entire vaccine series to get the most protection from it.
The Gardasil 9 vaccine is FDA-approved for use in people ages 9 through 45 years old. The Centers for Disease Control and Prevention (CDC) recommends the Gardasil 9 vaccine for children ages 11 or 12 years old.
recommends
The CDC recommends Gardasil 9 vaccination for most females through age 26 years old and for most males through age 21 years old.*
recommends
This age range is recommended so the vaccine can become effective before exposure to the human papillomavirus (HPV) could occur through sexual contact. Also, younger children tend to build up an immunity to HPV better than adults, which can help prevent possible infection even more.
human papillomavirus (HPV)
After age 21 for males or age 26 for females, the Gardasil 9 vaccine may still be recommended by your doctor, depending on if you have new sexual partners or are at a higher risk of getting HPV. Gardasil 9 is approved for people up to 45 years of age. It is not approved in adults older than 45 years of age.
You can find more details about the CDC’s vaccine recommendations for children and adults on their website.
children
adults
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
Gardasil 9 is available as a 0.5-mL injectable solution in either a vial or a prefilled syringe. It will be given either at your doctor’s office or at your pharmacy. You will not give a Gardasil 9 injection to yourself.
Gardasil 9 is recommended to prevent certain cancers caused by HPV such as cervical, vulvar, vaginal, anal, and head and neck cancers. The recommended dosage for adults ages 18 to 45 years old is a 0.5-mL injection into the muscle, usually in your upper arm.
cervical
vulvar
vaginal
anal
head and neck
It’s recommended that you receive three doses of Gardasil 9. After you receive one dose, you get a second dose 2 months later and a final dose 6 months after the first dose.
Gardasil 9 is effective at preventing genital warts that may be caused by HPV. By receiving the Gardasil 9 vaccine, some genital warts can be prevented. The dosage for adults ages 18 to 45 years old is a 0.5-mL injection into the muscle.
It’s recommended that you receive three doses of Gardasil 9. After you receive one dose, you get a second dose 2 months later and a final dose 6 months after the first dose.
The HPV virus can cause changes to your cervix, vulva, vagina, or anus. Changes are often referred to as dysplasia (the growth of abnormal cells that can eventually develop into cancer in some people).
dysplasia
The Gardasil 9 vaccine can help prevent some of these abnormal growths. The approved dosage for adults ages 18 to 45 years old is a 0.5-mL injection into the muscle, usually in your upper arm.
It’s recommended that you receive three doses of Gardasil 9. After you receive one dose, you get a second dose 2 months later and a final dose 6 months after the first dose.
In children ages 9 to 14 years old, Gardasil 9 can be given as either a two-dose or three-dose series.
If it’s given as a two-dose series, a child will get the first vaccine and then a second vaccine 6 to 12 months later. In a three-dose series, after the first dose, the child gets a second dose 2 months later and a third dose 6 months after the first dose.
Your doctor or pharmacist can help you decide whether a two-dose or three-dose series is better for your child.
Children ages 15 to 17 years old should get the three-dose series. After their first dose, they get a second dose 2 months later and a third dose 6 months after the first dose.
If you miss a dose of the Gardasil 9 vaccine, schedule an appointment to get it as soon as you can. You will not need to restart the series. However, you should continue the series where you left off. This is the best way to make sure you’re getting the most protection from HPV.
How Gardasil 9 is given
You should get Gardasil 9 according to your doctor or healthcare professional’s instructions.
The Gardasil 9 vaccine is given by your doctor or pharmacist as either a two-shot or three-shot series.
Whether you get two or three shots depends on your age, the time between each vaccination, and your doctor’s recommendation. The vaccine is given as a shot that goes into your muscle, usually in your upper arm.
The Gardasil 9 vaccine is FDA-approved for use in people ages 9 through 45 years old.
The Centers for Disease Control and Prevention (CDC) recommends the Gardasil 9 vaccine for children ages 11 or 12 years old. This helps make sure the person is protected from HPV before becoming sexually active. However, the CDC states that some people may benefit from the vaccine from the ages of 9 through 26 years old.
recommends
If you’re 26 to 45 years old, Gardasil may still be recommended. This depends on whether you’ve gotten the vaccine before and your risk factors, such as engaging in unprotected sex (sex without a barrier method such as a condom).
Talk with your doctor or pharmacist about getting the Gardasil 9 vaccine if you’re 26 to 45 years old. They can help you decide if the vaccine is right for you.
Gardasil 9 is currently not recommended for use in adults over the age of 45 years old.
Gardasil 9 and alcohol
There are no known interactions between Gardasil 9 and alcohol.
Talk with your doctor if you have questions about whether it’s safe for you to drink alcohol before or after getting the Gardasil 9 vaccine.
Gardasil 9 interactions
Gardasil 9 can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Below is a list of medications and treatments that can interact with Gardasil 9. This list does not contain all medications or treatments that could interact with Gardasil 9.
Before taking Gardasil 9, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any immune-suppressing treatments you’re having, and any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about interactions that may affect you, ask your doctor or pharmacist.
Getting the Gardasil 9 vaccine while you’re taking medications or having treatments that weaken your immune system may make the vaccine not work as well. This is because Gardasil 9 works by stimulating your immune system. That way, if you come into contact with human papillomavirus (HPV), your body can fight it off.
human papillomavirus (HPV)
If you’re taking medications or having treatments that weaken your immune system when you get Gardasil 9, you won’t build as much immunity toward HPV. This means the vaccine may not be as effective.
Examples of immune-suppressing medications or treatments include those used to treat cancer, such as:
radiation therapy
5-flurorouracil (Efudex)
6-mercaptopurine (Purinethol)
cyclophosphamide
dacarbazine
azathioprine (Imuran)
etoposide
Corticosteroids, when used in very high doses, are also immune suppressing medications. Examples of corticosteroids include prednisone and methylprednisolone (Medrol).
If you’re taking any of these medications or treatments, talk with your doctor or pharmacist about the best time to get your Gardasil 9 vaccine. They can help you decide if you should wait to get the vaccine or if it’s safe for you to get it while taking these medications or treatments.
There aren’t any herbs or supplements that have been specifically reported to interact with Gardasil 9. However, you should still check with your doctor or pharmacist to make sure it’s safe to take these products while getting the Gardasil 9 vaccine.
Gardasil 9 cost
As with all medications, the cost of Gardasil 9 can vary. The actual price you’ll pay depends on your insurance plan and your location.
Your insurance plan may require you to get prior authorization before approving coverage for Gardasil 9. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Gardasil 9.
If you’re not sure if you’ll need to get prior authorization for Gardasil 9, contact your insurance company.
If you need help understanding your insurance coverage, help is available. Merck Sharp & Dohme Corp., the manufacturer of Gardasil 9, offers the Merck Access Program. To learn more, call 855-210-1965 or visit the program website.
program website
If you need financial support to pay for Gardasil 9, Merck Sharp & Dohme Corp. offers the Merck Patient Assistance Program. For more information and to find out if you’re eligible for support, call 800-727-5400 or visit the program website.
program website
Alternatives to Gardasil 9
Gardasil 9 is currently the only vaccine approved in the United States to protect againstcertain diseases caused by human papillomavirus (HPV).
human papillomavirus (HPV)
In the past, another vaccine called Cervarix was used to prevent two types of HPV (compared to the nine types that Gardasil 9 protects against). There was also an older version of Gardasil that protected against four types of HPV. Both of these vaccines have been discontinued and are unavailable in the United States. This is because Gardasil 9 is very effective, protects against the largest number of types of HPV, and can protect both men and women from HPV-related diseases.
How Gardasil 9 works
Human papillomavirus (HPV) is a sexually transmitted virus. It’s spread by vaginal, anal, or oral sex with someone who’s infected with the virus. HPV can cause several conditions, including cervical, vulvar, vaginal, anal, and head and neck cancers, and genital warts.
Human papillomavirus (HPV)
cervical
vulvar
vaginal
anal
head and neck
genital warts
Gardasil 9 is a vaccine that works by activating your immune system against HPV. Your immune system’s main job is to identify and fight off germs. However, the first time your body sees a new germ, it may not fight it as quickly. Getting a vaccine helps to prepare your immune system in case you come into contact with that specific bacteria or virus later.
In the case of Gardasil 9, the vaccine gets your body ready to fight off HPV in case you’re exposed to it. Gardasil 9 is made of proteins that are similar to parts of the HPV virus. It doesn’t contain any actual HPV virus, so it can’t make you sick.
The proteins that look like HPV trigger your immune system, and your body builds up an immunity to those proteins. Therefore, if you’re exposed to any of the nine types of HPV the vaccine protects against, your body will already know how to fight the virus. This makes it much less likely that you’ll develop genital warts or cervical, vulvar, vaginal, anal, or head and neck cancer caused by HPV. It also lowers your risk of getting anal intraepithelial neoplasia (abnormal cell growth in the lining of your anus).
Typically, your body starts building up an immunity about 2 weeks after you get a vaccine. Therefore, Gardasil 9 will start working in your body within a couple weeks of getting the vaccine. In clinical studies, people who received Gardasil 9 had evidence of immune system cells that fight HPV by 1 month after their last dose.
clinical studies
It’s important to complete the vaccine series of two to three doses. Although the vaccine starts to build immunity in your body after one dose, the second (and in some cases, third) doses build up your immunity even more. You’ll be the most protected by getting the two-dose or three-dose series that’s recommended by your doctor or pharmacist.
Gardasil 9 and pregnancy
It’s not known if Gardasil 9 is safe to get during pregnancy. In clinical trials, pregnant females* were told to wait and get their vaccine after pregnancy.
clinical trials
If you’re pregnant or planning to become pregnant, talk with your doctor about the best time to receive the Gardasil 9 vaccine.
People who get the Gardasil 9 vaccine while pregnant can enroll in the Merck pregnancy registry by calling 800-986-8999. Pregnancy registries are important because they provide information that helps determine the safety of drugs and vaccines during pregnancy.
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
A long-term pregnancy study was done on the Gardasil vaccine. This is a now-discontinued vaccine that protected against four strains of HPV, while the Gardasil 9 vaccine protects against nine strains. Data is currently being collected on pregnant females* who receive the Gardasil 9 vaccine.
study
The study did not find an increased risk of miscarriage or major birth defects when Gardasil was given during pregnancy.
In the 5-year study, about 6.8% of pregnant females who got the vaccine had miscarriages. In the general population, miscarriages occur in about 15% to 20% of pregnancies.
15% to 20%
This study also looked at major birth defects, which occurred in about 2.4% of children born to mothers who received Gardasil while pregnant. In the general population, major birth defects occur in 2% to 4% of children.
2% to 4%
Gardasil 9 was looked at in animal studies where female rats were given the vaccine before mating or during pregnancy. In all cases, the fetuses were not harmed or affected by the vaccine. However, this result in animals may not show what happens in pregnant women.
animal studies
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
Gardasil 9 and birth control
It’s not known if the Gardasil 9 vaccine is safe to get during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving the Gardasil 9 series.
Gardasil 9 and breastfeeding
Not enough studies have been done to determine if Gardasil 9 is safe to receive while breastfeeding. It’s not known if Gardasil 9 can pass into breast milk. There is no animal data to determine if Gardasil 9 can pass into breast milk or harm a breastfeeding child.
If you are breastfeeding, talk with your doctor or pharmacist about the best time to get your Gardasil 9 vaccine.
Common questions about Gardasil 9
Here are answers to some frequently asked questions about Gardasil 9.
Yes, Gardasil 9 is considered safe and effective by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). It’s approved for use in children and adults ages 9 to 45 years old.
Food and Drug Administration (FDA)
Centers for Disease Control and Prevention (CDC)
Gardasil 9 is an inactive vaccine. This means it can’t cause HPV to occur in people who get the vaccine.
The most common side effects that can occur from a Gardasil 9 vaccine include pain, redness, or swelling at the injection site, headache, and fever. These side effects are very similar to side effects you may experience from other inactive vaccines.
Possibly. If you’ve already received the Gardasil vaccine, talk with your doctor about whether you should get Gardasil 9. There are currently no recommendations by the Advisory Committee on Immunization Practices on whether or not people who got the full Gardasil series should also get Gardasil 9.
Advisory Committee on Immunization Practices
Your doctor or pharmacist can help you decide if you should get the vaccine, depending on your age and risk factors.
Yes, you can receive the Gardasil 9 vaccine series even if you have HPV. There are more than 100 types of HPV, and Gardasil 9 protects against certain diseases caused bynine types. These nine types are the most common causes of HPV-related cancers or genital warts.
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If you have HPV, the vaccine will still help protect you from other types of HPV that you may become exposed to.
Yes, you can get other vaccines (inactive or live vaccines) at the same time as your Gardasil 9 vaccine. However, you may have a higher risk of swelling at the injection site if you get multiple vaccines at once.
In clinical trials, side effects were similar in people who got the Gardasil 9 vaccine only, and in those who received Gardasil 9 along with Menactra (meningococcal vaccine) and Adacel (which protects against tetanus, diphtheria, and whooping cough).
clinical trials
diphtheria
whooping cough
However, swelling at the injection site was more common in people getting the three vaccines together. Swelling occurred in 14.4% of people who received Menactra, Adacel, and Gardasil 9. This is compared to 9.4% of people who only received Gardasil 9.
No, Gardasil 9 is not a live vaccine. There is no live virus in the vaccine. Gardasil 9 is considered an inactive vaccine, meaning you can’t get HPV or any disease related to HPV from the vaccine.
The “9” in Gardasil 9 stands for the nine types of HPV that the vaccine protects against. There are more than 100 types of HPV. However, the nine types that Gardasil 9 protects against are the ones that cause the majority of HPV-related cancers in both males and females.* Gardasil 9 protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
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* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Sex and gender
Gardasil 9 precautions
Before taking Gardasil 9, talk with your doctor about your health history. Gardasil 9 may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
Yeast allergy. If you have a severe allergy to yeast, you shouldn’t receive the Gardasil 9 vaccine. The vaccine contains yeast, and if you have a severe allergy, you can develop a serious reaction such as trouble breathing. If you have a yeast allergy, it’s very important to talk with your doctor or pharmacist before getting the vaccine.
Fainting. If you have fainted from past vaccinations, Gardasil 9 might also cause you to faint. If you have a history of fainting, tell your doctor or pharmacist. They may have you lie down and elevate your feet while you get the vaccine. This can help prevent you from feeling dizzy or fainting. It can also help to prevent any injuries that can occur from falling after fainting.
Allergic reactions. If you have received Gardasil or Gardasil 9 in the past and had an allergic reaction to the past dose, talk with your doctor or pharmacist about getting the next dose. Depending on what your allergic reaction was, they may recommend that you not get any more doses of the vaccine.
Pregnancy. It’s not known if Gardasil 9 can affect a fetus. If you’re pregnant or planning to become pregnant, talk with your doctor or pharmacist about the best time to get a Gardasil 9 vaccine. For more information, see the “Gardasil 9 and pregnancy” section above.
Gardasil 9 and pregnancy
Breastfeeding. It’s not known if Gardasil 9 is harmful to a breastfeeding baby or if the vaccine can pass into breast milk. If you are breastfeeding, talk with your doctor or pharmacist about the best time to get your Gardasil 9 vaccine. For more information, see the “Gardasil 9 and breastfeeding” section above.
Gardasil 9 and breastfeeding
Note: For more information about the potential negative effects of Gardasil 9, see the “Gardasil side effects” section above.
Gardasil side effects
Professional information for Gardasil 9
The following information is provided for clinicians and other healthcare professionals.
Gardasil 9 is indicated in girls and women ages 9 through 45 years old to prevent:
cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
cervical cancer
vulvar cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
vulvar cancer
vaginal cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
vaginal cancer
anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
anal cancer
head and neck cancers, including oropharyngeal cancer, caused by HPV types 16, 18, 31, 33, 45, 52, 58
head and neck cancers
genital warts caused by HPV types 6 and 11
genital warts
cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 and cervical adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58
vulvar intraepithelial neoplasia (VIN) grades 2 and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58
vaginal intraepithelial neoplasia (VaIN) grades 2 and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58
anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58
Gardasil 9 is indicated in boys and men ages 9 through 45 years old to prevent:
anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
genital warts caused by HPV types 6 and 11
anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58
The exact way that Gardasil 9 protects against certain strains of HPV is unknown. However, it’s believed that after getting the vaccine, patients develop a humoral immune response that protects against dysplasia, genital warts, and the diseases related to the nine types of HPV that are covered by the vaccine.
Because Gardasil 9 is a vaccine, there is no information on the pharmacokinetics and metabolism of it.
Gardasil 9 is contraindicated for use in patients with an allergy to Gardasil 9. There is yeast in the vaccine, so if a patient has a severe yeast allergy, they should also not receive the Gardasil 9 vaccine.
Gardasil 9 should be stored in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). The vaccine should be protected from light and should never be frozen. After Gardasil 9 is taken out of the refrigerator, it should be given as soon as possible. The vaccine should not be out of the refrigerator for longer than 72 hours.
Gardasil 9 can also be in temperatures between 32°F and 36°F (0°C to 2°C) for up to 72 hours as well. However, it’s recommended that Gardasil 9 stay refrigerated at a temperature of 36°F to 46°F (2°C to 8°C) until the vaccine is administered.
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