Re: They said this
Good presentation. Data is good but depends on expanded data set being accepted by FDA.
A few data points to consider. Antibody titers reveal a lot. The mothers titers have a sharp peak, and decline, and this determines the amount transferred to child, and therefore the post birth outcomes. The transferred Ig has a half life that determines efficacy out after day 60 . This is where the observed efficacy and timing of the vaccination relative to birth shows a ‘logical story’ to explain different outcomes in the data. I think this supports the approval language be used to tightly control the vaccination window. Functional immunogenicity data explaining /supported by mechanism of action will be helpful for FDA to approve with ph4 follow up using modified vaccine timing limits.
I think a better data set than first pass and greater than fifty fifty FDA likes it.