CVR - Coronavirus Vaccines R&D Roadmap

Milestone
4.2.d

Principles for licensure

In progress
High priority

Establish principles, in coordination with global regulators, for using CHIM studies and immunobridging for licensure of broadly protective candidate vaccines

Progress Highlights

Laurens 2025 details how CHIM evidence has supported licensure/WHO decisions (e.g., US FDA approval of CVD 103-HgR cholera vaccine in 2016; WHO prequalification of a typhoid conjugate vaccine in 2017 partly based on CHIM), and may suffice for next-gen or combination products depending on regulator discussions.

Kapulu 2024 describes how, at the Fourth Controlled Human Infection meeting in Mombasa in 2023, CHIMs were discussed as potential tools to generate COPs and to up/down-select vaccine candidates.

The Infection Analytics program of the MusICC consortium is analyzing data from SARS-CoV-2 CHIM studies to identify and validate novel correlates of protection from virus transmission and reduced viral load to support the licensure of novel vaccine platforms.