加快国产宫颈癌疫苗上市的监管考量

Regulatory considerations about accelerating the approval of domestic HPV vaccines

宫颈癌是目前唯一病因明确、可以早期预防和治疗并有望根治的癌症,高危型人乳头瘤病毒(HPV)的持续感染是导致宫颈癌发生的必要因素。研究表明,WHO先后认可HPV 12个月持续感染、6个月持续感染可作为新HPV疫苗注册临床试验设计的替代终点,这一替代终点属于经过验证的替代终点,可直接用于新HPV疫苗临床试验。本文论证了我国应用这一替代终点加速新HPV疫苗研发上市的限制因素,并提出相应监管建议。

Cervical cancer is currently the only cancer that has a clear cause,can be prevented and treated early,and is expected to be completely cured.The persistent infection of high-risk human papillomavirus is a necessary factor leading to the occurrence of cervical cancer.Studies have shown that the WHO has recognized that 12-month persistent infection and 6-month persistent infection of HPV can be used as a surrogate endpoint for the new HPV vaccine registration clinical trial design.This surrogate endpoint is a validated surrogate endpoint and can be directly used in the clinical trials of new HPV vaccines.This article demonstrated the limiting factors in China for application of this surrogate endpoint to accelerate the development and approval of new HPV vaccines,and proposed corresponding regulatory recommendations.