GARDASIL 9 is a crucial vaccine indicated for the prevention of various cancers and precancerous lesions caused by Human Papillomavirus (HPV). This vaccine is approved for use in females and males aged 9 through 45 years, offering protection against diseases associated with nine HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58. Understanding the indications for GARDASIL 9 is vital for making informed decisions about preventative healthcare.
Who Should Consider GARDASIL 9?
GARDASIL 9 is recommended for females aged 9 to 45 to prevent:
- Cancers: Cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
- Precancerous Lesions: Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
- Genital Warts: Genital warts caused by HPV Types 6 and 11.
For males in the same age range (9 to 45 years), GARDASIL 9 is indicated for the prevention of:
- Cancers: Anal, oropharyngeal, and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
- Precancerous Lesions: Anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
- Genital Warts: Genital warts caused by HPV Types 6 and 11.
It’s important to note that the approval for oropharyngeal and head and neck cancer prevention is based on accelerated approval, contingent on further verification of clinical benefit.
What GARDASIL 9 Does Not Protect Against
While GARDASIL 9 offers significant protection, it’s crucial to understand its limitations:
- Non-Covered HPV Types: GARDASIL 9 does not protect against diseases caused by HPV types not included in the vaccine.
- Prior HPV Exposure: The vaccine may not be effective against HPV types to which an individual has already been exposed through sexual activity.
- Non-HPV Related Cancers: Not all cancers of the vulva, vagina, anus, oropharynx, and head and neck are caused by HPV. GARDASIL 9 only protects against those specifically caused by the HPV types it covers.
- Treatment: GARDASIL 9 is a preventative vaccine, not a treatment for existing HPV infections, genital lesions, cancers, or precancerous conditions like cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).
Vaccination with GARDASIL 9 may not guarantee protection for all recipients, highlighting the importance of continued regular health screenings.
Contraindications and Important Safety Information
GARDASIL 9 is contraindicated for individuals with known hypersensitivity, including severe allergic reactions to yeast, or those who have had a severe reaction to a previous dose of GARDASIL 9 or GARDASIL®.
Important Safety Considerations:
- Syncope (Fainting): Fainting can occur after vaccination, sometimes leading to falls and injuries. Therefore, a 15-minute observation period is recommended after administration. Syncope may be accompanied by tonic-clonic movements or seizure-like activity, which is usually transient.
- Pregnancy: The safety and effectiveness of GARDASIL 9 in pregnant women have not been established.
Common Adverse Reactions:
The most common side effects in females include injection-site pain, swelling, erythema (redness), and headache. In males, common reactions are injection-site pain, swelling, and erythema.
The duration of immunity for a 2-dose schedule in younger individuals is still being studied.
Dosage and Administration Guidelines
GARDASIL 9 is administered intramuscularly, typically in the deltoid muscle of the arm or the anterolateral area of the thigh.
Dosage Schedules:
- Individuals 9 through 14 years of age: A 2-dose or 3-dose schedule can be used.
- 2-dose schedule: The second dose is given 6–12 months after the first. If the interval is less than 5 months, a third dose is required at least 4 months after the second dose.
- 3-dose schedule: Administered at 0, 2 months, and 6 months.
- Individuals 15 through 45 years of age: A 3-dose schedule at 0, 2 months, and 6 months is recommended.
For complete and detailed information, it is essential to read the Prescribing Information and Patient Information provided by the manufacturer.
Disclaimer: This article provides general information about GARDASIL 9 and its indications. It is not a substitute for professional medical advice. Always consult with a healthcare provider for personalized medical guidance and decisions regarding HPV vaccination.
