Vacina contra HPV (Papilomavírus Humano)

Adolescentes de 9 a 14 anos (duas doses), adultos até 26 anos (três doses), alguns adultos até 45 anos por orientação médica.

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).