- What's crazy here is that FDA finally has a great head who actually tries to speed things up using Bayesian data modeling and understands drugs quite well (Marty
Makary) and does everything to make drug approval process cheaper and more efficient without compromising safety.
Unfortunately it seems like this decision was overwritten by his boss for political a win.
by jaybrendansmith
3 subcomments
- This technology is going to cure cancer someday. Too bad we won't get to use it. The FDA just killed 'future you'.
- https://archive.ph/sGvJW
by cosmicgadget
2 subcomments
- > In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.
> The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.”
Are they implying that a placebo should be the comparator?
- currently endorsed production technology is not responsive enough to produce an effective vaccine in time for unexpected viral antigen shift.
we need to cut the required lead time down to weeks, rather than months.
we also need to stand up a surveilance network again.
by clumsysmurf
1 subcomments
- Unfortunate, just recently I read
"Influenza vaccination is associated with significantly lower odds of myocardial infarction (MI), according to a large meta-analysis published late last week in BMC Public Health."
https://www.cidrap.umn.edu/influenza-vaccines/new-analysis-l...
- yes, lets find more ways to kill people besides bringing back the measles. God what a race to the bottom for this administration..
by Domenic_S
3 subcomments
- [flagged]
- [flagged]
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