GARDASIL® 9 (Slovakian)

GARDASIL® 9 Product Overview

GARDASIL® 9 is a recombinant vaccine designed to prevent diseases caused by Human Papillomavirus (HPV), particularly types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Approved for use in individuals aged 9 through 45 years, it targets both genders for protection against HPV-related diseases, including cervical, vulvar, vaginal, and anal cancers, as well as genital warts.

GARDASIL® 9 Key Features and Benefits

This vaccine provides broad protection against multiple HPV strains, reducing the risk of associated diseases significantly. The inclusion of nine HPV types ensures a wider scope of efficacy compared to earlier vaccines.

• 9 HPV types covered, providing extensive protection.
• Prevents cervical, vulvar, vaginal, anal, and oropharyngeal cancers.
• Also effective against genital warts caused by HPV types 6 and 11.
• Administered as a suspension for intramuscular injection in a 0.5 mL dose.

GARDASIL® 9 Indications for Use

The vaccine is indicated for boys and men as well as girls and women from 9 to 45 years of age to prevent the following:

• Cancers: Cervical, vulvar, vaginal, anal, and head/neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
• Genital warts caused by HPV types 6 and 11.
• Precancerous lesions: CIN (Cervical Intraepithelial Neoplasia) grades 1, 2, and 3; VIN (Vulvar Intraepithelial Neoplasia); and AIN (Anal Intraepithelial Neoplasia).

GARDASIL® 9 Dosage and Administration

Administered intramuscularly, the dosing schedule varies based on the recipient’s age:

• Ages 9-14 years: 2-dose schedule (0, 6-12 months) or 3-dose schedule (0, 2, 6 months).
• Ages 15-45 years: 3-dose schedule (0, 2, 6 months).
• Shake well before use to ensure a white, cloudy suspension.

GARDASIL® 9 Efficacy and Clinical Studies

Clinical studies show high efficacy in preventing diseases associated with vaccine-covered HPV types:

• CIN 2/3 and AIS: 98.2% efficacy in preventing cervical lesions in women aged 16-26.
• Genital warts: 99% efficacy against HPV types 6 and 11.
• Demonstrates robust immune response in both genders across all eligible age groups.

GARDASIL® 9 Safety Information and Side Effects

The vaccine has a well-established safety profile. Common side effects are generally mild to moderate and include:

• Injection-site reactions: Pain (89.9%), swelling (40%), erythema (34%).
• Systemic reactions: Headache (14.6%), fever, and dizziness.
• Severe allergic reactions: Rare but require immediate medical attention.

GARDASIL® 9 Precautions and Limitations of Use

Despite its efficacy, there are limitations:

• Does not eliminate the need for regular cancer screenings.
• Does not protect against HPV types not covered by the vaccine.
• May not provide protection for individuals already exposed to certain HPV types.

GARDASIL® 9 Storage and Handling

Proper storage and handling are critical for maintaining vaccine potency:

• Store at 2°C to 8°C and protect from light.
• Do not freeze; frozen vaccines should not be used.
• Inspect vials or syringes for particulate matter or discoloration before use.

GARDASIL® 9 Manufacturer Details

GARDASIL® 9 is manufactured by Merck Sharp & Dohme LLC, a globally recognized leader in pharmaceuticals and vaccines.

• Manufacturer contact: 1-800-986-8999 (for vaccine inquiries).

GARDASIL® 9 FAQs

What is GARDASIL® 9?

GARDASIL® 9 is a vaccine that prevents diseases caused by nine HPV types, including cancers and genital warts.

Who should receive GARDASIL® 9?

It is recommended for males and females aged 9 to 45 years.

What is the dosing schedule?

For individuals aged 9-14, a 2-dose or 3-dose schedule is available. For those aged 15-45, a 3-dose schedule is required.

Are there any contraindications?

Yes, it should not be administered to individuals with severe allergic reactions to yeast or any vaccine component.

Can GARDASIL® 9 be given during pregnancy?

Although studies show no increased risk of adverse outcomes, vaccination is typically deferred until after pregnancy.