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Decisions as to whether or not to pursue regulatory approval for, example, expanded coverage of the HPV vaccine to men, or older age groups, is very commonly informed by cost-benefit calculations. I've worked on those projects, seen presentations by my colleagues, etc. There was a good two years of my life where this was what I worked on (mostly strain replacement post-vaccination).

It's a level of evidence that's generated (usually) prior to ACIP, and it is presented to them, while there is not necessarily a bright line threshold.

https://pmc.ncbi.nlm.nih.gov/articles/PMC7652907/



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