Select Safety Information For Gardasil 9
GARDASIL ®9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® .
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.
The most common local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common local and systemic reactions in males were injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been established.
How Do You Catch Hpv
HPV is transmitted from one person to another by genital contact. Although this most often occurs during sexual intercourse, it can also occur during oral or anal sex or through genital-to-genital contact in the absence of sexual intercourse.
HPV infections are unique. First, most people never know they were infected. Unlike a cold in which symptoms develop a few days after exposure to the virus, HPV infections are typically not symptomatic. Second, HPV infections can last for long periods of time. The average length of infection is about eight months however, for about 1 of every 10 women, the infection lasts longer than two years. It is in this group of women that there is an increased risk of developing cervical cancer. Cervical cancer often doesnt occur until 20 years after the initial infection.
How Possible Is Thomas’ Request To Reevaluate Contraception Same
So it is not true that Covid vaccines are manufactured using fetal cell lines, nor do they contain any aborted cells.
Rather, the vaccines contain messenger RNA genetic material that instructs our cells to make proteins, which then train the immune system to fight off the coronavirus. They also include fatty substances called lipids that help RNA cross our cell membranes, as well as salt, sugar, and a few substances that help stabilize the other ingredients.
In defending its vaccine mandate, lawyers for New York also noted that laboratory-grown stem cells, which derive from cells collected from a fetus nearly 50 years ago, were also used for testing the rubella vaccine.
Writing for the three dissenters, himself and Justices Samuel Alito and Neil Gorsuch, Thomas nevertheless cited the misleading claim.
The majority of justicesdeclined Thursday to take up the legal challenge brought by health care workers who oppose the states vaccine mandate on religious grounds.
When the requirement was first imposed last August as a way to help prevent the spread of the latest Covid variant, it allowed exceptions based on medical reasons or religious objections. But the religious exemption was later removed. New York Gov. Kathy Hochul, a Democrat and a Roman Catholic, said that she was not aware of any sanctioned religious objection from any organized religion and that religious leaders including the pope were encouraging people to get vaccinated.
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What Are The Benefits Of The Hpv Vaccines
In women who have never been infected with HPV, the vaccines prevent almost 100% of cases of cervical cancer caused by the HPV types covered by the vaccines.
The HPV9 vaccine also prevents about:
- 78% of cases of anal cancers in men caused by the two main types of HPV
- 90% to 100% of cases of genital warts in men and women caused by 2 other types of HPV
Who Should Get The Vaccine
Gardasil® and Gardasil®9
Gardasil® and Gardasil®9 are approved for use in females aged 9-45 and males aged 9-26.
These vaccines require 3 doses to be given over the course of 6 months . For healthy, immunocompetent, non-HIV infected individuals 9 to less than 15 years age, two doses of the vaccine at least 6 months apart may be given.
- Recommendations for use, which come from the National Advisory Committee on Immunization , were initially released in February 2007, and updated in January 2012, 2015, 2016, and 2017 as new evidence emerged. NACI recommends Gardasil® and Gardasil®9 in females and males 9 to less than 27 years of age, including women who have had previous Pap test abnormalities, cervical cancer or individuals who have previously had genital warts. NACI also recommends that these vaccines may be administered to individuals 27 years of age and older at ongoing risk of exposure to HPV. HPV is a sexually transmitted infection, and ideally, the vaccine should be administered before sexual debut in order to ensure maximum benefit.
For more details on the NACI Statement, see “Update on Human Papillomavirus Vaccines”.
Cervarix®
Cervarix® is approved for use in females aged 9 to 45. At this time Cervarix® has not been approved for use in males in Canada.
The vaccine requires 3 doses to be given over the course of 6 months . For healthy, immunocompetent, non-HIV infected females 9 to less than 15 years age, two doses of the vaccine at least 6 months apart may be given.
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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.
Can I Get Gardasil 9 If I Have Hpv
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.
If you have HPV, the vaccine will still help protect you from other types of HPV that you may become exposed to.
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What Are The Side Effects
Many people have no side effects from the vaccines. For those that do, common side effects may include soreness, redness and swelling where the vaccine was given. Fever, fatigue, headache, and muscle or joint ache may also occur. As with other vaccines, fainting has occurred following HPV vaccination. Fainting can occur with any medical procedure – not just the HPV vaccine and people recover quickly.
It is important to stay in the clinic for 15 minutes after getting any vaccine because there is a very rare possibility, between one in 100,000 and one in a million, of a life-threatening allergic reaction called anaphylaxis. This may include hives, difficulty breathing, or swelling of the throat, tongue or lips. Should this reaction occur, your health care provider is prepared to treat it. Emergency treatment includes administration of epinephrine and transfer by ambulance to the nearest emergency department. If symptoms develop after you leave the clinic, call 9-1-1 or the local emergency number.
It is important to always report serious or unexpected reactions to your health care provider.
National Advisory Committee On Immunization Recommendations
In February 2007, based on sound scientific consideration, the National Advisory Committee on Immunization issued recommendations for the use of Gardasil® for females ages nine to 26. In January 2012, NACI issued an update on human papillomavirus vaccines, which included recommendations in light of the expanded use of Gardasil® for males ages nine to 26 and females ages 27 to 45, as well as the approval of Cervarix® for females. In 2015, NACI issued updated recommendations on the HPV immunization schedule, including recommendations for either a 2- or 3- dose schedule in healthy, immunocompetent, non-HIV infected individuals 9-14 years of age, based on new evidence about the efficacy of HPV vaccines in this population. In 2016, NACI issued recommendations on the new vaccine, Gardasil®9, authorized for use in Canada. In 2017, NACI provided evidence-based recommendations on a 2-dose schedule for the most recently approved HPV vaccine, and summarized evidence and resulting recommendations on HPV immunization in immunocompromised populations.
Currently, all HPV vaccines are recommended by NACI for:
- girls and women 9 to less than 27 years of age, including those who have had previous Pap test abnormalities, cervical cancer or genital warts, and may be administered to women 27 years of age and older at ongoing risk of exposure to HPV
HPV vaccination prior to onset of sexual activity and exposure to HPV is recommended to maximize the benefit of the vaccine.
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Who Should Not Get An Hpv Vaccine Or Who Should Wait
Pregnant women should not get any HPV vaccine at this time, even though they appear to be safe for both mother and the unborn baby. If a woman who is pregnant does get an HPV vaccine, its not a reason to consider ending the pregnancy. Women who started a vaccine series before they learned they were pregnant should complete the series after the pregnancy.
Make sure the health care provider knows about any severe allergies. The following should not get an HPV vaccine:
- Those with a severe allergy to yeast should not receive Gardasil or Gardasil 9.
- Anyone who has ever had a life-threatening allergic reaction to anything else contained in the vaccines
- Anyone who has had a serious reaction to an earlier dose of HPV vaccine
Vaccination Of Specific Populations
Pregnancy and breastfeeding
HPV vaccines are not recommended for use in pregnancy because data on HPV vaccination in pregnancy are limited. HPV vaccine, however, has not been causally associated with adverse outcomes of pregnancy or adverse events to the developing fetus. In the absence of data, it is recommended that initiation of the HPV vaccine series should be delayed until after completion of the pregnancy. If a woman is found to be pregnant after initiating the vaccination series, completion of the series should be delayed until after pregnancy. No intervention is required if vaccine has been administered during pregnancy.
Vaccine recipients and health care providers are encouraged to report any exposure to HPV4 or HPV9 vaccine during pregnancy to the vaccine manufacturer at 1-800-567-2594. Exposure to HPV2 vaccine during pregnancy should be reported to the vaccine manufacturer at 1-800-387-7374.
There are limited data on the effects on breastfed infants from HPV vaccination of their mothers however, there have been no reported adverse events thought to be vaccine-related. Therefore, HPV vaccine may be administered to breastfeeding women.
Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional information about vaccination of women who are pregnant or breastfeeding.
Immunocompromised persons
Refer to Immunization of Immunocompromised Persons in Part 3 for additional information about vaccination of people who are immunocompromised.
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Can Men Get Vaccinated With Gardasil9
Yes. In boys and men ages 9 to 45, GARDASIL®9 helps protect against infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and the following diseases caused by HPV:
- Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Genital warts caused by types 6 and 11
- Abnormal and precancerous anal lesions caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58
For more information about GARDASIL®9, talk to your healthcare professional.
Before Taking This Medicine
To make sure Gardasil 9 vaccine is safe for you, tell your doctor if you have ever had:
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an allergy to yeast, polysorbate 80, or to other vaccines
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a weak immune system or
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treatment with cancer medicine, steroids, or other drugs that can weaken your immune system.
Tell your doctor if you are pregnant or plan to become pregnant. If you get pregnant before you receive all needed doses of this vaccine, you may need to wait until after your baby is born to finish the series of shots.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of human papillomavirus vaccine on the baby.
It may not be safe to breastfeed while using human papillomavirus vaccine. Ask your doctor about any risk.
Gardasil 9 vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.
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How Does The Hpv Vaccine Work
Gardasil has been the HPV vaccine used in the NHS vaccination programme since 2012.
Sometime during the 2021 to 2022 academic year, the HPV vaccine used in the NHS programme will switch to Gardasil 9.
Gardasil 9 protects against 9 types of HPV: 6, 11, 16, 18, 31, 33, 45, 52 and 58. Between them, types 16 and 18 are the cause of most cervical cancers in the UK . Types 31, 33, 45, 52 and 58 cause an additional 15% of cervical cancers.
These types of HPV also cause most anal cancers, and some genital and head and neck cancers.
HPV types 6 and 11 cause around 90% of genital warts, so using Gardasil 9 helps protect girls and boys against both cancer and genital warts.
HPV vaccination does not protect against other infections spread during sex, such as chlamydia, and it will not stop girls getting pregnant, so it’s still very important to practise safe sex.
Gardasil 9 And Children
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.
Vaccinating children at a young age helps make sure theyre 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, theyll be protected from HPV-related changes in the cervix, vagina, vulva, anus, and head and neck tissues. Theyll also be protected from genital warts caused by the types of HPV prevented by the vaccine.
Talk with your childs doctor about their risk for HPV. Together, you can decide when its right to give the vaccine to your child.
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Who Owns The Patent For Gardasil
Mercks Gardasil-4, the first VLP based vaccine, was patented in the U.S. in 1998 and introduced in the market in 2006 . Between the first patent approval and 2010, 81 HPV vaccine related patents were granted in the U.S. with Merck leading the way with 24 granted patents .
What Gardasil vaccine was discontinued?
The quadrivalent HPV vaccine targeted HPV 16 and 18 as well as 6 and 11, which cause most cases of genital warts the last available doses in the United States expired in May 2017 it has been replaced by Gardasil 9.
My Healthcare Professional Ran Out Of Gardasil9 And Had Me Pick Up My Vaccine At The Pharmacy Is This Okay
Yes. The doctors office may not carry GARDASIL®9 or it may have just run out. If your healthcare professional does not have GARDASIL®9, he or she may write you a prescription so that you can pick up your vaccine at a pharmacy and then come back to be vaccinated. The vaccine should be given as soon as possible after being taken out of the fridge.
When your healthcare professional writes you a prescription for GARDASIL®9, be sure to get specific directions about picking up and storing the vaccine.
For more information about GARDASIL®9, talk to your healthcare professional.
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Gardasil 9 For Preventing Cervical Vulvar Vaginal Anal And Head And Neck Cancers Caused By Hpv
Gardasil 9 is FDA-approved to prevent several types of cancers that can be caused by the human papillomavirus . HPV is spread by vaginal, anal, or oral sex with someone who has the virus. Even if a person doesnt show any symptoms, they may still be infected with HPV.
According to the , HPV is the most common sexually transmitted infection.
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.
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:
- 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, youd 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.
Effectiveness
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. In the Gardasil 9 group, the vaccine was 96.7% effective at preventing abnormal changes or cancer in the cervix, vulva, or vagina.
How Long Does The Hpv Vaccine Protect For
Studies have shown that the vaccine protects against HPV infection for at least 10 years, although experts expect protection to last for much longer.
But because the HPV vaccine does not protect against all types of HPV that can cause cervical cancer, it’s important that all women who receive the HPV vaccine also have regular cervical screening once they reach the age of 25.
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How Long Will The Vaccine Prevent Hpv Infection
How long a vaccine will protect people is never known when the vaccine is first introduced. Current research shows that the vaccine is effective, and theres no sign that the protection decreases with time. Research will continue to look at how long protection against HPV lasts, and if booster shots will be needed.