HPV Vaccine

Подростки 9–14 лет (две дозы), взрослые до 26 лет (три дозы), отдельные взрослые до 45 лет по назначению врача.

Severe allergic reaction to previous dose or any component (including yeast — Gardasil 9). Pregnancy (defer until after delivery — no teratogenicity demonstrated but recommended to postpone). Moderate to severe acute illness (defer). No contraindication in immunocompromised — 3-dose schedule recommended.

Very common: injection site pain (78–90%), swelling (24%), erythema (22%). Common: headache (12–14%), fever (5%), nausea, dizziness. Syncope: relatively common in adolescents — observe 15 minutes post-vaccination (seated or supine). CIOMS/WHO Global Advisory Committee: no confirmed causal association with autoimmune conditions, chronic fatigue, CRPS, or premature ovarian insufficiency.

Age 9–14 years: 2 doses IM at 0 and 6–12 months (or single dose per WHO SAGE 2022 for girls 9–20y). Age ≥15 years: 3 doses IM at 0, 2, 6 months. Immunocompromised (any age): 3 doses. Dose: 0.5 mL IM in deltoid muscle. Minimum intervals: dose 1→2: 4 weeks; dose 2→3: 12 weeks; dose 1→3: 5 months.

Gardasil 9: near 100% efficacy against vaccine-type persistent infection and precancerous lesions (CIN2+, VIN2+, VaIN2+, AIN2+). Single-dose: KEN SHE trial (Kenya): 97.5% efficacy against persistent HPV 16/18 at 18 months. Real-world impact: 87% reduction in cervical cancer (Scotland birth cohort), 90% reduction in genital warts (Australia). Estimated to prevent 90% of cervical cancers if administered pre-exposure.

Store at +2°C to +8°C. Do not freeze (aluminum adjuvant damaged). Protect from light. Ready-to-use prefilled syringe. Shelf life: 36 months.

Can be co-administered with MenACWY, MenB, Tdap, hepatitis B, influenza, and COVID-19 vaccines at different injection sites without interference. No known drug interactions. Immunosuppressive therapy may reduce immune response — vaccinate when possible, consider 3-dose schedule.

Pregnancy: Not recommended — defer until after delivery.

HPV vaccination (Gardasil 9) is not recommended during pregnancy as a precautionary measure due to limited data.

• If pregnancy is discovered after initiating the vaccine series, defer remaining doses until after delivery.

• No teratogenicity has been demonstrated in clinical trials or post-marketing surveillance (pregnancy registry data for quadrivalent Gardasil).

• Inadvertent vaccination during pregnancy is NOT an indication for termination.

• No special monitoring needed if vaccinated inadvertently.

Breastfeeding: Safe.

HPV vaccine (Gardasil 9) is safe during breastfeeding. It is a recombinant, non-infectious vaccine. Breastfeeding women can be vaccinated without restriction. No modification to breastfeeding schedule required.

Pediatric use:

• Routine vaccination: 9–14 years of age (gender-neutral, WHO recommendation).

• Schedule by age:

  • 9–14 years: 2 doses at 0 and 6–12 months.
  • ≥15 years: 3 doses at 0, 2, 6 months.
  • WHO SAGE (2022): single-dose regimen for girls 9–20 years is equally effective.

• Minimum interval between doses: 5 months (2-dose schedule), 4 weeks/12 weeks/5 months (3-dose schedule).

• Syncope: observe adolescents for 15 minutes post-vaccination (common in this age group).

• Immunocompromised children (including HIV-positive): 3-dose schedule recommended regardless of age.

Geriatric use:

• Catch-up vaccination is available up to 45 years (FDA-approved) through shared clinical decision-making for 27–45 years.

• Efficacy in adults >26 years is lower than in younger age groups (fewer HPV-naïve individuals).

• Not routinely recommended for adults ≥46 years.

• Older adults who are HPV-naïve may still benefit from vaccination if at risk.

Vaccination does not treat existing HPV infection — preventive only. Most effective before sexual debut. Cervical screening must continue regardless of vaccination status (non-vaccine HPV types can still cause cancer). Male vaccination equally important for herd immunity, prevention of HPV-related male cancers, and elimination of reservoir. Single-dose evidence growing (Costa Rica, India, Kenya trials).