Saturday, September 30, 2023

What Is Gardasil 9 Vaccine

How Has The Hpv Vaccination Programme Changed

HPV vaccine (Gardasil®9) explained for parents and guardians short clip 1

In July 2018, it was announced that the HPV vaccine would be extended to boys aged 12 to 13 years in England.

This decision was based on advice from the Joint Committee on Vaccination and Immunisation , the independent body that advises UK health departments on immunisation.

Since the 2019 to 2020 school year, both 12- to 13-year-old boys and girls in school Year 8 have been eligible for the HPV vaccine.

A catch-up programme for older boys is not necessary as evidence suggests they’re already benefiting greatly from the indirect protection that’s built up from 10 years of the girls’ HPV vaccination programme.

Age Recommendations For Gardasil 9

The Gardasil 9 vaccine is FDA-approved for use in people ages 9 through 45 years old. The Centers for Disease Control and Prevention the Gardasil 9 vaccine for children ages 11 or 12 years old.

The CDC recommends Gardasil 9 vaccination for most females through age 26 years old and for most males through age 21 years old.*

This age range is recommended so the vaccine can become effective before exposure to the human papillomavirus 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.

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 CDCs vaccine recommendations for adults on their website.

* Sex and gender exist on spectrums. Use of the terms male and female in this article refers to sex assigned at birth.

Information About Gardasil 9

GARDASIL 9 is a shot that is usually given in the arm muscle. GARDASIL 9 may be given as 2 or 3 shots.

  • For persons 9 through 14 years of age, GARDASIL 9 can be given using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second shot should be given 612 months after the first shot. If the second shot is given less than 5 months after the first shot, a third shot should be given at least 4 months after the second shot. For the 3-dose schedule, the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.
  • For persons 15 through 45 years of age, GARDASIL 9 is given using a 3-dose schedule the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.

The appropriate dosing schedule will be determined by your health care professional.

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Who Should Get The Hpv Vaccine

All people ages 9 to 45 can get the HPV vaccine to protect against genital warts and/or different types of HPV that can cause cancer. Its recommended that children get the vaccine at age 11 or 12, so theyre fully protected years before they become sexually active.

But regardless of your age, talk with your nurse or doctor to find out if the HPV vaccine could benefit you.

What Is In The Vaccine


The HPV vaccine used in the New Zealand Immunisation Programme from 2017 is Gardasil® 9. The vaccine contains HPV virus-like particles of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. These particles are proteins from the outer shell of the virus. The VLPs do not contain DNA fragments in a form that could allow them to infect cells or reproduce. The particles mimic the HPV virus so that the immune system makes antibodies against it. These recombinant types of vaccine have been used around the world for over 20 years.

Each 0.5ml dose of the vaccine also contains a small amount of aluminium, which stimulates the immune response. Aluminium has been safely and effectively used in vaccines for more than 70 years. The vaccine also contains tiny amounts of sodium chloride , L-histidine , Polysorbate 80, sodium borate and sterile water.

The vaccine does not contain preservatives, antibiotics or any human or animal materials.

The Medsafe website has further information about Gardasil 9:

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Is Gardasil 9 Safe

Centers for Disease Control and Prevention . Its approved for use in children and adults ages 9 to 45 years old.

Gardasil 9 is an inactive vaccine. This means it cant 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.

Is The Hpv Vaccine Safe

Yes. Because the HPV vaccine is made using only the surface protein from the virus, it can’t cause HPV and, therefore, can’t cause cervical cancer. The vaccine may cause redness and tenderness at the site of injection. The vaccine may also cause a low-grade fever in a small number of recipients.

More than 100 million doses of HPV vaccine have been given to people in the United States, and safety networks have continued to monitor reactions to the HPV vaccine since its licensure. Despite concerns raised by the media and some citizen groups, no cause-effect links have been found between HPV vaccine and adverse events, including blood clots, allergic reactions, strokes, seizures, Guillain-Barré Syndrome , birth defects, miscarriages, infertility or premature ovarian failure, or infant/fetal deaths. While fainting episodes following HPV vaccination have been reported, the rates have not been higher than those following receipt of other vaccines for teens. Because of the possibility of fainting, teens are recommended to remain at the office for about 15-30 minutes after getting immunized.

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How Is The Hpv Vaccine Given

The HPV vaccine is given as 2 injections into the upper arm spaced at least 6 months apart.

It’s important to have both doses of the vaccine to be properly protected.

If you missed the HPV vaccine offered in school Year 8, you can get it for free up until your 25th birthday.

Men who have sex with men , and trans men and trans women who are eligible for the vaccine, will also need 2 doses of the vaccine given 6 months apart.

MSM who are HIV positive or have a weakened immune system need to have 3 doses of the HPV vaccine.

If you need 3 doses of the vaccine:

  • the 2nd dose should be given at least 1 month after the 1st dose
  • the 3rd dose should be given at least 3 months after the 2nd dose

It’s important to have all vaccine doses to be properly protected.

Immune Responses To Gardasil 9 Using A 2

What to Know About the Gardasil-9 Vaccine

Effectiveness of Gardasil 9 against persistent infection and disease related to vaccine HPV types in 9- through 14-year-old girls and boys who received a 2-dose regimen was inferred from non-inferiority comparison conducted in the PPI population in Study 8 of GMTs following vaccination with Gardasil 9 among 9- through 14-year-old girls and boys who received a 2-dose regimen with those among 16- through 26-year-old girls and women who received a 3-dose regimen . Anti-HPV GMTs at one month after the last dose among 9- through 14-year-old girls and boys who received 2 doses of Gardasil 9 were non-inferior to anti-HPV GMTs among 16- through 26-year-old girls and women who received 3 doses of Gardasil 9 .

One month following the last dose of the assigned regimen, between 97.9% and 100% of subjects across all groups became seropositive for antibodies against the 9 vaccine HPV types .

In the same study, in girls and boys 9 through 14 years old, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than in girls 9 through 14 years old after a 3-dose schedule . The clinical relevance of these findings is unknown.

Duration of immunity of a 2-dose schedule of Gardasil 9 has not been established.

Table 12: Summary of Anti-HPV cLIA Geometric Mean Titers in the PPI Population at One Month After the Last Vaccine Dose Among Subjects Who Received 2 Doses or 3 Doses of Gardasil 9


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Vaccine Safety Studies Of Specific Conditions

  • More than 160 studies have been conducted in multiple countries to look at whether specific adverse events can be linked to HPV vaccine. These studies have shown HPV vaccines have a reassuring safety profile with no confirmed serious adverse events following vaccination.
  • Some studies have focused on specific outcomes such as venous thromboembolism, GuillainBarré syndrome, and diabetes, while other studies have investigated multiple different health problems.

Hpv Vaccination Is Preventing Cancer

HPV infections and cervical precancers have dropped since 2006, when HPV vaccines were first used in the United States.

  • Among teen girls, infections with HPV types that cause most HPV cancers and genital warts have dropped 88 percent.
  • Among young adult women, infections with HPV types that cause most HPV cancers and genital warts have dropped 81 percent.
  • Among vaccinated women, the percentage of cervical precancers caused by the HPV types most often linked to cervical cancer has dropped by 40 percent.

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More Common Side Effects

The more common side effects of Gardasil 9 can include:

  • pain, swelling, or redness at the injection site
  • bruising, bleeding, itching, or a lump at the injection site

Most of these side effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk with your doctor or pharmacist.

Typical Dosing For Gardasil 9


Age 9 to 14 years:

  • This vaccine is typically a 2-dose series for this age group, given as 1 injection at 0 months and at 6 to 12 months.
  • If the second dose is given earlier than 5 months after the first dose, a third dose should be given at least 4 months after the second dose.
  • Children with weakened immune systems should receive 3 doses, given as 1 injection at 0 months, 2 months, and 6 months.

Age 15 to 45 years:

  • This vaccine is a 3-dose series for this age group, given as 1 injection at 0 months, 2 months, and 6 months.

Each injection is given into the shoulder or thigh muscle by a healthcare provider.

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Gardasil 9 For Preventing Genital Warts Caused By Hpv

Gardasil 9 is approved to prevent genital warts caused by HPV.


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.

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.

Who Can Have The Hpv Vaccine Through The Nhs Vaccination Programme

The 1st dose of the HPV vaccine is routinely offered to girls and boys aged 12 and 13 in school Year 8. The 2nd dose is offered 6 to 24 months after the 1st dose.

If you miss either of your HPV vaccine doses, speak to your school immunisation team or GP surgery and make an appointment to have the missed dose as soon as possible.

It’s important to have both doses of the vaccine to be fully protected.

If youre eligible and miss the HPV vaccine offered in Year 8 at school, its available for free on the NHS up until your 25th birthday for:

  • girls born after 1 September 1991
  • boys born after 1 September 2006

Read more about HPV vaccination safety and the possible side effects.

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Safety And Effectiveness Of Gardasil

The HPV vaccine issafe and effective in women above the recommended age of 45. Insurance coverage is not available to women over 45 because it is not considered cost-effective to give everyone the vaccine. Based on effectiveness studies, women over 45 who have had few lifetime sexual partners or been in a few long-term relationships are likely to benefit just as much as younger women. Older women may derive less benefit from Gardasil vaccination compared to younger women.

What Are The Side Effects Of Gardasil 9

HPV vaccine (Gardasil®9) explained for parents and guardians short clip 3

With any medication, there are risks and benefits. Even if the medication is working, you may experience some unwanted side effects.

Contact your doctor immediately if you experience any of the following:

  • Serious allergic reactions: hives, rash, shaking, itching, nausea, flushing, dizziness, shortness of breath, chest pain

The following side effects may get better over time as your body gets used to the medication. Let your doctor know immediately if you continue to experience these symptoms or if they worsen over time.

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How Gardasil 9 Is Given

You should get Gardasil 9 according to your doctor or healthcare professionals 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 doctors recommendation. The vaccine is given as a shot that goes into your muscle, usually in your upper arm.

What Is Gardasil 9

Gardasil 9 is a vaccine thats used to prevent certain diseases caused by human papillomavirus .

HPV is a virus that can cause very serious conditions such as cervical, vulvar, vaginal, , 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.

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.

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How Effective Is The Hpv Vaccine

The HPV vaccine is one of the most effective vaccines you can get. Studies show that the HPV vaccine works extremely well to prevent high-risk HPV and the problems it can cause. If you get all recommended shots of the HPV vaccine before you have sex, it can lower your chances of getting genital warts and cancer caused by HPV by up to 99%.

The HPV vaccine works best when you get it years before you have any sexual contact with another person. Thats why its recommended to get vaccinated at ages 11-12. But even if youve already had sex or know youve had HPV, its still a good idea to get the HPV vaccine. There are several strains of HPV that can cause cancer and genital warts, and the vaccine can protect you from any strains you havent been exposed to yet.

What Research Is Being Done On Strategies To Prevent Hpv Infection


If a single dose of HPV vaccine were effective, that would be an important advance. A large observational study using national data from women across Australia found that one dose of HPV vaccine was as effective as two or three doses in preventing high-grade cervical lesions . An analysis of data from a community-based clinical trial of Cervarix in Costa Rica, found that even one dose of the vaccine caused the body to produce approximately nine times more antibodies against HPV than the body produces in response to a natural HPV infection, and those antibody levels persisted for 11 years . In addition, the rates of HPV infection remained low for at least 10 years .

Two NCI-led clinical trials have been launched in Costa Rica to confirm and extend these findings. The ESCUDDO study, a randomized double-blind controlled trial involving 20,000 girls ages 1216 years, is testing whether one dose of either Cervarix or Gardasil 9 is as effective as two doses at preventing persistent cervical infection with HPV. PRIMAVERA-ESCUDDO, a non-randomized open-label trial, will provide earlier and complementary results to ESCUDDO about the immunogenicity of one dose of Cervarix in girls ages 914 years compared with three doses of Gardasil in women ages 1825 years.

Selected References
  • Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. New England Journal of Medicine 2002 347:16451651.

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    Gardasil 9 For Boys And Men

    Gardasil 9 is best known for preventing cervical cancer in females.* However, human papillomavirus , the virus that Gardasil protects against, can also affect males.*

    HPV can cause and certain head and neck cancers as well as genital warts in males or females.

    * Sex and gender exist on spectrums. Use of the terms male and female in this article refers to sex assigned at birth.

    The Gardasil 9 dosage your doctor prescribes will depend on several factors. These include:

    • 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. Its important to complete the entire vaccine series to get the most protection from it.

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