Regarding dosing of the COVID genetic vaccines (mRNA, recombinant adenovirus) versus the more traditional vaccines (including Novavax). There are some inconvenient truths here.
First, the current genetic vaccines (Sanofi, J&J, Pfizer, Moderna) did not undergo the time tested assessments of dose ranging and dose timing clinical studies, to the best of my knowledge. I have direct first person report of how the dose was selected for Moderna (confidential source), and it was basically a SWAG by committee consensus. Personally, for what it is worth, it is my opinion that the current mRNA vaccines selected a dose that was too high, too far up on the sigmoidal dose response curve - so that we may have excess adverse events. Dose selection with vaccines is usually about careful balancing of adverse events with potency/efficacy/effectiveness, with a bias towards safety.
(Correction, proper dose ranging was done for Pfizer, limited sample size)
Second big inconvenient truth is that the spike protein is the actual active agent, in terms of eliciting an immune response. And in the case of the traditional vaccines, the dose of spike protein is defined relatively precisely. With the genetic vaccines, it is not (to the best of my knowledge). I know of no data wherein the mean, median, range etc of total amount of spike protein produced in a patient after administration of the COVID genetic vaccine has been defined. Usually, the FDA is quite persnickety about such things, but I am not aware of this key variable having been determined. Therefore, the range and severety of adverse events potentially attributable to the level of expressed spike protein may reflect patient to patient differences in genetic transfer efficiency and subsequent spike expression. #Science #Data #honestyisthebestpolicy #Transparency #evidencebasedmedicine
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