Immunobridging as a regulatory strategy: science, standardization, and global equity

“....immunobridging has enormous potential to accelerate vaccine access globally, but it is not a shortcut.”

Ashling Cannon, Editor, Vaccine Insights, speaks with Marion F Gruber, Vice President, Public Health and Regulatory Affairs, IAVI, about the scientific foundations and regulatory dimensions of immunobridging as a licensure strategy for vaccines. They discuss the conditions under which immunological bridges can be considered well-founded, the spectrum of pathogens for which correlates of protection are well or poorly established, and the challenges of generalizability across populations. Gruber also reflects on her published perspective that discussed alternative regulatory pathways for filovirus vaccines, the divergence between regulatory frameworks, and what a well-functioning international immunobridging framework would need to look like to support equitable global vaccine access.

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