Human papillomavirus vaccines developed by Escherichia coli expression system: progress and perspectives from China

Cervical cancer remains a major global public health threat, disproportionately affecting low-income and middle-income countries (LMICs). Prophylactic human papillomavirus (HPV) vaccination is a cornerstone of its prevention but traditional eukaryotic expression systems limit accessibility due to high costs and complex processes. In contrast, China has achieved a pivotal breakthrough by developing HPV vaccines using the Escherichia coli prokaryotic system, which offers rapid scalability, cost-effectiveness and high yield. Building on this foundation, China officially integrated HPV vaccination into its National Immunisation Programme in 2025. This landmark achievement has garnered significant international attention and provides a valuable reference for other LMICs in shaping their immunisation strategies. This review summarises progress on two E. coli –derived HPV vaccines: bivalent Cecolin (HPV16/18) and nonavalent Cecolin9 (HPV6/11/16/18/31/33/45/52/58). Synthesised clinical evidence shows their favourable safety profiles, robust immunogenicity and high protective efficacy—demonstrating robust humoral immunity, high protection against vaccine-type persistent infections and precancerous lesions and consistent tolerability across age groups and dosing schedules. Notably, Cecolin has obtained WHO prequalification and has been introduced into China’s NIP, while Cecolin9 extends coverage to five additional high-risk genotypes (HPV31/33/45/52/58) that account for a substantial proportion of cervical cancers in China. The review also addresses the global implications of these vaccines for cervical cancer elimination particularly in resource-limited settings as well as remaining challenges. In conclusion, China’s E. coli -based HPV vaccine platform provides a cost-effective, scalable model that can inform cervical cancer prevention strategies in other LMICs, supporting the WHO’s global elimination goal.