An Expert Report on Cecolin®: A Bivalent HPV Vaccine Produced in Escherichia coli

I. Product Identification and Composition

This section provides a comprehensive identification of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli), detailing its nomenclature, manufacturer, formulation, and physical characteristics. This foundational information is essential for regulatory assessment, programmatic planning, and comparative analysis against other available human papillomavirus (HPV) vaccines.

1.1. Nomenclature and Regulatory Identity

The vaccine is marketed under the brand name Cecolin®.[1] Its formal scientific name,

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli), precisely describes its core attributes: it is produced using recombinant DNA technology, it is bivalent (targeting two HPV types), it specifically protects against HPV types 16 and 18, and its production host is the bacterium Escherichia coli.[1]

The explicit inclusion of the production system, (Escherichia coli), in its formal name is a significant differentiator. This is not merely a technical footnote but a strategic declaration of its underlying manufacturing technology. It immediately distinguishes Cecolin® from other globally recognized HPV vaccines. For instance, Cervarix®, another bivalent vaccine also targeting HPV-16 and -18, is produced in an insect cell-baculovirus expression system and utilizes a different adjuvant system (AS04).[4] Similarly, the Gardasil® line of vaccines (quadrivalent and nonavalent) is produced in the yeast

Saccharomyces cerevisiae.[6] This distinction in production platform is fundamental to understanding Cecolin's unique value proposition related to manufacturing scalability and cost-effectiveness, which will be explored in subsequent sections.

1.2. Manufacturer and Development