GARDASIL 9 is a vaccine used for the prevention of cancers and diseases caused by nine types of human papillomavirus (HPV), including the high-risk types responsible for cervical, anal, vulvar, vaginal, and oropharyngeal cancers, as well as genital warts. It is a recombinant vaccine that contains virus-like particles (VLPs) from HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. These VLPs are not infectious and cannot cause HPV infections but stimulate the immune system to produce antibodies, thereby offering protection against these HPV types. GARDASIL 9 is administered via intramuscular injection and is recommended for both males and females.

Pharmaceutical Properties:

• Active Ingredients: GARDASIL 9 contains virus-like particles (VLPs) from the following nine HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58.

• Appearance: The vaccine is a clear, colorless, or slightly opalescent solution in a prefilled syringe.

• Formulation: GARDASIL 9 is formulated as an injectable suspension. Each dose is 0.5 mL and is administered intramuscularly, typically into the deltoid muscle of the upper arm.

• Stability: The vaccine should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and should not be frozen. Once opened, the vaccine should be used immediately or according to the manufacturer's instructions.

• Excipients: GARDASIL 9 contains several stabilizers and buffers to maintain the stability and effectiveness of the vaccine.

Indications for Use:

GARDASIL 9 is indicated for the prevention of HPV-related cancers and diseases in both males and females. Specifically, it is recommended for:

1. Cervical Cancer Prevention: Protection against HPV types 16 and 18, which cause the majority of cervical cancers.

2. Genital Warts Prevention: Protection against HPV types 6 and 11, which cause genital warts.

3. Anal, Vulvar, and Vaginal Cancer Prevention: Protection against HPV types 16, 18, 31, 33, 45, 52, and 58.

4. Oropharyngeal Cancer Prevention: Protection against HPV types 16, 18, 31, 33, 45, 52, and 58, which are implicated in cancers of the throat and mouth.

5. Vaccination Schedule: GARDASIL 9 is recommended for use in both girls and boys starting at ages 9 to 14, with a two-dose schedule. For individuals aged 15 to 26, a three-dose schedule is advised.

Mechanism of Action:

GARDASIL 9 works by stimulating the immune system to produce antibodies against the nine HPV types it targets. The vaccine contains virus-like particles (VLPs) that mimic the structure of the HPV virus but are non-infectious. When the vaccine is administered, the immune system recognizes the VLPs as foreign invaders and produces a protective immune response. This includes the formation of antibodies that can neutralize the actual HPV virus if the individual is later exposed. The immune response is long-lasting and provides protection against HPV infection and its associated cancers and diseases.

Clinical Protocol in Dubai:

1. Patient Selection:

   • GARDASIL 9 is recommended for both males and females, ideally starting the vaccination series between the ages of 9 and 14 years, although it can be administered up to age 26 for those who have not been vaccinated.

   • The vaccine is most effective when administered before any exposure to HPV, making early vaccination ideal.

   • GARDASIL 9 is also recommended for individuals who are at higher risk of HPV-related diseases, including those with compromised immune systems or individuals with a history of genital warts.

2. Dosage and Administration:

   • Routine Schedule (9-14 years): A two-dose schedule is recommended, with the second dose given 6 to 12 months after the first dose.

   • For Older Individuals (15-26 years): A three-dose schedule is recommended, with doses administered at 0, 2, and 6 months.

   • Route of Administration: GARDASIL 9 is administered intramuscularly, typically in the deltoid muscle of the upper arm.

   • Precautions: The vaccine should not be given to individuals who have experienced severe allergic reactions to any component of the vaccine, including yeast. It is also contraindicated for individuals with moderate to severe illness until they recover.

3. Monitoring:

   • After vaccination, individuals should be observed for at least 15 minutes to monitor for any immediate allergic reactions.

   • Common side effects include pain at the injection site, redness, swelling, fever, and dizziness. These are typically mild and resolve on their own.

   • Individuals should report any side effects or symptoms that persist beyond a few days, such as prolonged fever or unusual fatigue.

4. Precautions and Contraindications:

   • Contraindications: GARDASIL 9 should not be administered to individuals who have a known severe allergy to any component of the vaccine, including yeast.

   • Pregnancy: GARDASIL 9 is not recommended during pregnancy, and vaccination should be deferred until after pregnancy if the individual becomes pregnant between doses.

   • Lactation: The vaccine can be administered during breastfeeding, but it is always advisable to consult with a healthcare provider.

Other Characteristics:

• Adverse Effects:

  • The most common adverse effects are mild and localized to the injection site, including pain, swelling, and redness.

  • Systemic side effects, such as fever, headache, dizziness, and nausea, may occur but are typically short-lived.

  • Rarely, more severe side effects, such as anaphylaxis, may occur, but this is extremely uncommon.

• Efficacy:

  • GARDASIL 9 has shown strong efficacy in preventing infections caused by the nine HPV types it targets. It is particularly effective in preventing cervical cancer, anal cancer, and genital warts.

  • The vaccine provides long-lasting immunity, which significantly reduces the risk of developing HPV-related cancers and diseases.

GARDASIL 9 is a critical vaccine for the prevention of HPV-related cancers and diseases. Its broad coverage, including protection against nine HPV types, makes it a key component in public health efforts to reduce the burden of cervical, anal, vulvar, vaginal, and oropharyngeal cancers, as well as genital warts. By vaccinating at an early age, individuals can achieve maximum protection before potential exposure to the virus. As a safe and effective vaccine, GARDASIL 9 is an essential tool in preventing HPV-related diseases and improving overall public health.