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AI-Generated response:

How effective is Gardasil for women over 30?

Answer generated on June 4, 2024

The AI-generated responses are for illustration purposes only and should not be used for medical purposes.

Gardasil 9 is effective for women over 30, but the benefits may be smaller compared to younger age groups due to the likelihood of prior HPV exposure.

Safety and efficacy data specifically for this age group are moderate in quality.[1]

  • Gardasil 9 has been approved for use in adults up to age 45, including women over 30, based on clinical trials showing efficacy in preventing HPV-related diseases.[1]

  • The vaccine is effective against nine HPV types which are responsible for various cancers and genital warts.[2-3]

  • Immunogenicity data show high seroconversion rates for HPV types covered by the vaccine in adults aged 27 through 45 years.[1]

  • The Advisory Committee on Immunization Practices (ACIP) supports shared clinical decision-making for vaccination in adults aged 27 through 45, recognizing potential benefits for those not previously vaccinated or at risk for new HPV infection.[1]

  • The vaccine's efficacy in older adults is supported by trials demonstrating significant protection against persistent HPV infections and related diseases.[1]

Additional info

The decision to vaccinate women over 30 should consider individual risk factors for new HPV infections, such as new sexual partners or lack of previous exposure to the vaccine's HPV types. While the overall benefit of vaccination in this age group may be reduced compared to younger individuals, it still offers protection against HPV types not previously encountered. Clinicians should engage in shared decision-making with their patients, discussing the potential benefits and limitations based on individual sexual history and previous HPV exposure. This approach aligns with the ACIP's recommendations for adults aged 27 through 45 years.

References

Reference 1

1.

Meites E, Szilagyi PG, Chesson HW, et al. MMWR. Morbidity and Mortality Weekly Report. 2019;68(32):698-702. doi:10.15585/mmwr.mm6832a3. Copyright License: CC BY

Publish date: August 5, 2019.

At the June 2019 ACIP meeting, two policy issues were considered: 1) harmonization of catch-up vaccination for all persons through age 26 years, and 2) vaccination of adults aged >26 years. Two Evidence to Recommendations documents were developed (https://www.cdc.gov/vaccines/acip/recs/grade/HPV-harmonization-etr.html) (https://www.cdc.gov/vaccines/acip/recs/grade/HPV-adults-etr.html) and presented along with proposed recommendations; after a public comment period, ACIP members voted unanimously to harmonize catch-up vaccination recommendations across genders for all persons through age 26 years. ACIP members also voted 10–4 in favor of shared clinical decision-making for adults aged 27 through 45 years, recognizing that some persons who are not adequately vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range. Vaccine efficacy and safety. Data were considered from 11 clinical trials of 9vHPV, 4vHPV, and/or 2vHPV in adults aged 27 through 45 years, along with supplemental bridging immunogenicity data. In per-protocol analyses from three trials, 4vHPV and 2vHPV demonstrated significant efficacy against a combined endpoint of persistent vaccine-type HPV infections, anogenital warts, and cervical intraepithelial neoplasia (CIN) grade 1 (low-grade lesions) or worse. In nine trials, seroconversion rates to vaccine-type HPV after 3 doses of any HPV vaccine were 93.6%–100% at 7 months after the first dose. Overall evidence on benefits was GRADE evidence level 2, for moderate-quality evidence. In nine trials, few serious adverse events and no vaccine-related deaths were reported. Overall evidence on harms was also GRADE evidence level 2, for moderate-quality evidence. In the efficacy trial that was the basis for 9vHPV licensure for adults through age 45 years, per-protocol efficacy of 4vHPV among women aged 24 through 45 years was 88.7% (95% confidence interval [CI] = 78.1–94.8), and intention-to-treat efficacy was 47.2% (95% CI = 33.5–58.

Reference 2

2.

Elsevier ClinicalKey Drug Monograph

Content last updated: March 1, 2024.

Mechanism Of Action To evaluate efficacy against HPV types 31, 33, 45, 52, and 58, the vaccine was administered to 7,099 girls and women age 16 to 26 years. In this study primary efficacy was determined based on a composite clinical endpoint of cervical, vulvar, vaginal cancers and neoplasia. An analysis of the data starting 7 months post-dose found the vaccine to be effective in preventing HPV type 31-, 33-, 45-, 52-, and 58-related persistent infections and diseases, as observed through a reduction in the incidence of Pap test abnormalities, cervical and external genital biopsy, and definitive therapy. For HPV 6, 11, 16, and 18, immunogenicity was determined by comparing the vaccine induced geometric mean titers (GMTs) with those induced by the HPV quadrivalent vaccine (Gardasil quadrivalent). At 7 months post-dose, Gardasil 9 was found to be non-inferior to Gardasil quadrivalent, with 99.7% of girls and women (age 9 to 26 years) becoming seropositive for each of the 4 HPV types. Results from these two studies were subsequently used to infer vaccine efficacy in boys and girls age 9 to 15 years. This was accomplished through a non-inferiority comparison of the GMTs in boys and girls age 9 to 15 years with those observed in females age 16 to 26 years. One study evaluated the immune response to Gardasil 9 in 921 girls and women (ages 12 to 26 years) who had recently received (within a 1 year period) 3 Gardasil quadrivalent injections. Data from this study found the anti-HPV 31, 33, 45, 52, and 58 GMTs induced by Gardasil 9 to be 25% to 63% of those that were observed in Gardasil 9 recipients who had not previously received Gardasil quadrivalent. The clinical relevance if these results are unknown. Efficacy of Gardasil 9 in preventing infections/diseases from HPV types 31, 33, 45, 52, and 58 in individuals previously vaccinated with Gardasil quadrivalent has not been evaluated. The duration of immunity after vaccination with the Gardasil 9 series has not been established.

Reference 3

3.

Elsevier ClinicalKey Derived Clinical Overview

• The availability of HPV vaccination is expected to alter the landscape of anal cancer management. The currently available vaccine, Gardasil 9, is effective against nine subtypes of the HPV. Current guidelines recommend vaccination for all children ages 11 to 12 yr, girls and women ages 13 to 26 yr, boys and men ages 13 to 21 yr, and high-risk men ages 22 to 26 yr. An expanded indication now allows men and women ages 27 to 45 yr to undergo catchup HPV vaccination. • In a recent randomized trial, 4459 participants with biopsy-proven high-grade squamous intraepithelial lesions (HSIL) underwentrandomization to active therapy or surveillance.Treatments included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod and was continued until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 mo; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer. With a median follow-up of 25.8 mo, the rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57%.

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