Sept. 6, 2025 - Epoch Times
02:25
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| Time | Text |
|---|---|
| The information that was presented now in retrospect appears to have been incomplete. | |
| So Marianne Damasy, working with others, evaluated in particular two of the signals that were present in the data, but not entirely clear in the presentations at that ACIP meeting having to do with the new RSV monoclonal antibody product that we collectively ended up endorsing for virtually all newborns, much like the hepatitis B vaccine. | |
| But we had a couple of, we had two precisely dissenters in that vote, who voted not to uh recommend, one of which was the same Retz of Levy. | |
| And there were the particular issue that raised Retsif's uh, you can almost think of it as spidey sense, his intuitive sense that something wasn't right, was uh data having to do with deaths in clinical trials. | |
| Deaths is a rare event in this case, fortunately, post-inoculation with these monoclonal antibodies, which are not vaccines. | |
| Uh there was an imbalance in deaths with more deaths, slightly more in the inoculated group compared to the control group. | |
| Furthermore, that trend of statistically not significant, but still numerically split with the same trend was present in the studies involving the other marketed monoclonal antibody product. | |
| Uh I think that that what this death signal teaches, and and I suspect I I we've had some informal discussions. | |
| I think that there's support for this. | |
| When we have death data like that, uh the ACP is going to need to require that we get our hands on the primary clinical records associated with those events so we can make our own assessment of whether those were related or unrelated. |
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