Human Papillomavirus Bivalent

• Primary (approved) indications
• Active immunization of females to prevent premalignant cervical lesions (cervical intraepithelial neoplasia grades 2 and 3; CIN2/3), adenocarcinoma in situ (AIS), and invasive cervical cancer caused by persistent infection with human papillomavirus (HPV) types 16 and 18.
• Protection against persistent infection and disease associated with HPV-16 and HPV-18 in the indicated age groups.
• Age groups commonly approved
• Typically licensed for females starting at age 9 and up through 25 (some approvals and national programs extend recommendations to older age groups under specific circumstances).
• Clinically accepted/off-label uses
• Use in males is less common for the bivalent product but possible in some regions.
• May provide protection against other HPV-related anogenital precancers driven by HPV-16/18; use according to national guidelines.

• Dose and formulation
• 0.5 mL per dose; intramuscular injection (deltoid muscle preferred). Do not administer intravenously, subcutaneously, or intradermally.
• Routine schedules
• Ages 9–14 years: Two-dose schedule — Dose 1 at month 0; Dose 2 at month 6 (minimum interval 5 months).
• Age 15 years and above: Three-dose schedule — Dose 1 at month 0; Dose 2 at month 1 (or 1–2 months); Dose 3 at month 6.
• Immunocompromised persons
• Should receive a 3-dose schedule regardless of age.
• Missed doses
• If a dose is delayed, administer as soon as possible; do not restart the series.
• Administration notes
• Shake well before use. Inspect for discoloration or particulate matter.

The bivalent HPV vaccine contains recombinant L1 major capsid proteins from HPV types 16 and 18, which self-assemble into non-infectious virus-like particles (VLPs). These VLPs induce a strong humoral immune response by stimulating neutralizing antibody production, which prevents the initial infection of epithelial cells by HPV. The vaccine does not contain live virus and cannot cause infection.

• Absorption/Distribution: Antigens remain locally at the injection site and lymph nodes, triggering immune activation.
• Metabolism/Elimination: VLPs are degraded by normal proteolytic pathways; no renal or hepatic metabolism is involved.
• Onset & duration of protection: Antibody responses develop within weeks; protection persists for years after series completion. No booster is routinely recommended at present.

• Pregnancy: Not recommended during pregnancy. If pregnancy occurs after vaccination has started, remaining doses should be postponed until after pregnancy.
• Lactation: May be administered during breastfeeding if needed; limited data show no significant harm to infants.
• Data limitations: Evidence from registries is limited; routine caution is advised.

• Preventive vaccine — Recombinant virus-like particle (VLP) vaccine.
• Subclass: Bivalent HPV vaccine (targets HPV types 16 and 18).

• Severe allergic reaction to any component of the vaccine.
• Previous severe hypersensitivity reaction to a prior dose of the vaccine.

• Syncope (fainting): Common after vaccination, especially in adolescents; observe for 15 minutes post-injection.
• Anaphylaxis: Emergency treatment should be available.
• Immunocompromised persons: May have reduced immune response.
• Administration: Do not inject intravenously or intradermally.

• Common: Pain, redness, swelling at injection site; fatigue, headache, muscle pain, mild fever, nausea.
• Uncommon/Rare: Severe allergic reactions (anaphylaxis), neurological events such as Guillain-Barré syndrome (very rare).

• No clinically significant interactions identified.
• Can be given with other vaccines at different injection sites.

• WHO recommends a two-dose schedule for individuals starting vaccination at ages 9–14; three doses for immunocompromised or those starting at 15 years and older.
• Booster doses are not currently recommended.

• Store at 2°C to 8°C. Do not freeze.
• Protect from light; keep in original packaging.
• Shake well before use; discard if discolored or contains foreign particles.