3 ms·
> Probably referring to the fact the majority had fairly noticeable side effects especially with the second dose. Did anyone look at the actual data? [1, Table
by ethbro 6y ago
> Probably referring to the fact the majority had fairly noticeable side effects especially with the second dose.
Did anyone look at the actual data? [1, Table S1-S3]
At the 100 μg 2nd dose, the most frequent moderate symptoms were fatigue (40%, "some interference with activity"), chills (26.7%, "some interference with activity"), and headache (26.7%, "repeated use of non-narcotic pain reliever > 24 hours or some interference with activity"), with no severe events reported.
In other words, pretty much what you'd expect if you asked your immune system to floor it. I wouldn't characterize these as concerning.
In all probability, we won't see sufficiently numerous cohorts until Phase II is published, Phase III is in process. Remember, this was n=15 for most arms.
> One person taking the highest dose had a 103+ fever with the second...
That's why they standardized on the 100 μg dose for Phase III [2], as a result of Phase I/II safety profile and efficacy.
[1] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2022483/suppl_file/nejmoa2022483_appendix.pdf https://www.nejm.org/doi/suppl/10.1056/NEJMoa2022483/suppl_f...
[2] https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273 https://investors.modernatx.com/news-releases/news-release-d...