Real-world data support HPV vaccine efficacy in off-label age groups

A prospective analysis demonstrates the effectiveness of HPV vaccination in reducing progression to biopsy-confirmed precancerous lesions and HPV persistence in a cohort of South Korean women in off-label age groups.

“[Our study shows that] HPV vaccination significantly reduced both persistent HPV infection and histologic progression in Korean women aged 27–39 years, [confirming its] protective effects in women aged 27–40 years,” noted a group of researchers from The Catholic University of Korea in their poster presentation at ESMO Gyn 2025.

On multivariate logistic regression analysis, vaccination status alone did not significantly reduce HPV persistence in the entire matched cohort. [ESMO Gyn 2025, abstract 13P]

However, on subgroup analysis, there was a significant reduction in HPV persistence among vaccinated women aged 27–39 years (odds ratio [OR], 0.40, 95 percent confidence interval [CI], 0.16–0.97; p=0.043). No significant benefit was observed in the cohort of women aged ≥40 years (OR, 1.91, 95 percent CI, 0.78–4.71; p=0.15).

With regard to histologic progression, a 5-year cumulative incidence analysis showed fewer events among women aged ≥27 years who were vaccinated as opposed to those who were not (n=13 vs 61; p=0.044). This protective effect was substantiated on Cox proportional hazards regression analysis, which yielded a hazard ratio of 0.23 (95 percent CI, 0.08–0.67; p=0.007).

Increasing public awareness

In women, cervical cancer remains the fourth most common cancer globally. “As public awareness of HPV-related cervical cancers has increased, more Korean women are choosing to receive HPV vaccination beyond the recommended age of 26 years,” the researchers explained.

However, there is insufficient data on the real-world efficacy of HPV vaccination in the older population, they pointed out.

The researchers sought to evaluate the effectiveness of HPV vaccination in off-label age groups using real-world data. A multicentre cohort study was conducted using data from the Korea HPV Cohort Study, a national research project conducted under the supervision of the Korea Disease Control and Prevention Agency across eight hospitals from 2010 to 2021.

Eligible participants were Korean women aged ≥20 years who were HPV DNA-positive, irrespective of genotype, and had atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion (SIL) on cytology. The analysis included 1,427 women who were stratified according to HPV vaccination status and age group (≤26 vs ≥27 years).

In 1,231 women aged ≥27 years, 1:1 propensity score matching (PSM) was applied to reduce confounding. Following PSM, the matched cohort comprised 562 participants, half of whom were vaccinated.

The primary outcomes were persistent HPV infection and biopsy-confirmed histologic progression. Follow-up included HPV DNA tests and cytology at 6-month intervals. Colposcopy-directed biopsy was done for high-grade SIL or worse.

Going beyond currently approved age range

Taken together, the findings expand the established efficacy of HPV vaccination, which has conventionally focused on women aged <27 years, and highlight the potential benefits of HPV vaccination among women in older age groups, the investigators noted.

“These findings may inform future recommendations to expand HPV vaccination to older populations beyond the currently approved age range, with further research needed to validate these results across diverse populations and clarify long-term efficacy and safety in older age groups,” they said.

“[The study also provides] evidence-based insights to guide future vaccination policies,” the researchers added.