T
tareload
Guest
My only issue was the suggestion that there was no clinical data collected in humans, and that the FDA was moving ahead only with data collected it mice. The human data, as limited as it is, has been publicly available since June.
First paragraph I quoted from US today article:
The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.
There is no human data for the BA.5 booster.
See the presentation you linked to. At this point why would any company need to use EUA to approve a booster?
Here let me help:
The companies say clinical trials for the BA.4/BA.5 vaccines will begin next month; they need clinical data both for full approval of the vaccines—their recent submissions are only for emergency use authorization—and to help develop future updates. Presumably they will measure recipients’ antibody levels, but not the vaccine’s efficacy against infection or severe disease. Such trials are very expensive and were not done for the BA.1 shot either.