Er, yes, I do think I’m saying that we should use something else besides the linked standard.
Object level: Feeling blah for a day and staying in bed doesn’t strike me as “severe” or “horrible”. I’m deeply confused by the fact that you seem to be arguing in favor of standards that would say that staying in bed for a day is “horrible” or “severe”.
I’m not trained in this area, but just for comparison, “Common Terminology Criteria for Adverse Events v3.0” https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf has a “grade 3/severe” category for most types of adverse effects, and includes hypertension requiring two drugs to treat; hypotension requiring more that 24 hours’ treatment; insomnia so bad that it interferes with your ADLs; and a weight gain of 20% or more from baseline. The “fatigue” I experienced would be a 2/moderate at best under their standard (page 11), but more likely a 1 as I had no actual trouble with ADLs.
Meta level: I think you should give serious, possibly overwhelming, consideration to how such data would get reported. Vaccine-hesitant people will hear about the study results through popular media: “30% of recipients reported ‘severe’ side effects!” and will never see or hear what “severe” means in the study’s context. They will assume that “severe” means whatever they think “severe” means. If I were one such person, I would be expecting side effects far worse than I experienced.
This is a bit like saying: “I know that the vaccine is horrible given the general standards, so we should use something else”.
Novavax does manage a low amount of grade 3 side effects.
There’s another question about whether there are long term side effects that also interesting.
Er, yes, I do think I’m saying that we should use something else besides the linked standard.
Object level: Feeling blah for a day and staying in bed doesn’t strike me as “severe” or “horrible”. I’m deeply confused by the fact that you seem to be arguing in favor of standards that would say that staying in bed for a day is “horrible” or “severe”.
I’m not trained in this area, but just for comparison, “Common Terminology Criteria for Adverse Events v3.0” https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf has a “grade 3/severe” category for most types of adverse effects, and includes hypertension requiring two drugs to treat; hypotension requiring more that 24 hours’ treatment; insomnia so bad that it interferes with your ADLs; and a weight gain of 20% or more from baseline. The “fatigue” I experienced would be a 2/moderate at best under their standard (page 11), but more likely a 1 as I had no actual trouble with ADLs.
Meta level: I think you should give serious, possibly overwhelming, consideration to how such data would get reported. Vaccine-hesitant people will hear about the study results through popular media: “30% of recipients reported ‘severe’ side effects!” and will never see or hear what “severe” means in the study’s context. They will assume that “severe” means whatever they think “severe” means. If I were one such person, I would be expecting side effects far worse than I experienced.