RE: Population-level impact of the bivalent, quadrivalent, and candidate nonavalent human papillomavirus vaccines: A comparative model-based analysis

摘要

In a recent article in the Journal, Van de Velde et al. (1) assume that human papillo-maviras (HPV) vaccines "prevent infection but do not alter the natural history of disease in individuals already infected by a vaccine type." We question whether this assumption is correct. In 2006, the US Food and Drug Administration (FDA) expressed concerns about "the potential for Gardasil to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine-relevant EEPV types at baseline" (2). The increase in high-grade cervical disease rates among a subgroup of vaccinated girls and women noted by the FDA was not statistically significant. However, a subsequent ecological study of approximately 2.9 million Australian girls and women (3) documented that the introduction of Gardasil was associated with statistically significant increases in high-grade cervical disease rates among women aged more than 21 years but with statistically significant decreases in high-grade cervical disease rates among girls and women aged less than 18 years.