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FDA just posted the BioNTech/Pfizer vaccine data here.
Lots of good stuff.
https://www.fda.gov/media/144245/download
example: Looks like one dose may induce meaningful protection around day 10.
Lots of good stuff.
https://www.fda.gov/media/144245/download
example: Looks like one dose may induce meaningful protection around day 10.
Looks like the vaccine works across subgroups regardless of comorbidity.
* I wouldn't worry about the cancer subgroup, way too small and confidence intervals too large to say much at all.
* I wouldn't worry about the cancer subgroup, way too small and confidence intervals too large to say much at all.
No difference in efficacy across age and sex as subgroups. Notably, worked in >65 population.
There were 2 deaths in the vaccine group and 4 in the placebo group. No deaths were related to COVID infection. Deaths consistent with the baseline rate for the population studied.
But, no overall survival benefit to vaccination. @VPrasadMDMPH reject right? I kid, I kid.
But, no overall survival benefit to vaccination. @VPrasadMDMPH reject right? I kid, I kid.
Only 3 significant adverse events were judged as related to the vaccine.
1) Shoulder injury where vaccine was administered
2) Lymph node swelling (representing immune system response)
3) One patient with prior cardiac disease had a ventricular arrhythmia following vaccine admin.
1) Shoulder injury where vaccine was administered
2) Lymph node swelling (representing immune system response)
3) One patient with prior cardiac disease had a ventricular arrhythmia following vaccine admin.
Note that these significant adverse events related to vaccine only occurred in 3 out of 21,823 patients (0.01%) and 2 of them I wouldn't really even count (shoulder injury?). Not bad!
No evidence of informative censoring (ie increased withdrawal or loss to follow up in vaccine group).
What does the vaccine cause?
Pain. But hey, no pain no gain baby.
Pain. But hey, no pain no gain baby.
And 16% of participants (this table <55 yo) had fever after vaccination. Nearly all fevers were mild.
It's like you tell the CAR-T patients, that's how you know it's working!
It's like you tell the CAR-T patients, that's how you know it's working!
The vaccine cause cause fatigue, headache, muscle, and joint pain. The general trend is that these symptoms are worse on the second injection, consistent with immune memory responding more briskly/robustly.
The strongest significant adverse event signal against the vaccine was 8 episodes of appendicitis in vaccine group vs 4 in placebo. But this was just statistical noise, I double checked (p=0.38).
A few friends have asked me if I think the vaccine will be safe in pregnancy.
Pregnant patients were excluded from the trial, but 23 patients became pregnant during the course of the trial or were otherwise not screened out. No safety issues yet (though obvi underpowered)
Pregnant patients were excluded from the trial, but 23 patients became pregnant during the course of the trial or were otherwise not screened out. No safety issues yet (though obvi underpowered)
Overall the vaccine looks amazing. Big win for science. Looking forward to what mRNA vaccines will do not just for COVID, but infectious disease in general.
