Initially, 21 male rats were dosed with 100ug mRNA but some adverse clinical signs after 24 hours meant they reduced the dose to 50ug. One of the 21 rats started declining with irregular respiration and after 30 hours was piloerect, hunched and hypersensitive to noise stimulus. The animal had to be humanely killed and the diagnostic necropsy showed a finding in the liver. The levels of LNPs in this rat are not documented alongside the other results so it would be interesting to know what they were like. All of the animals in this 100ug group had a reduction in bodyweight and didn’t eat their food. No adverse effects were noted in any males in the 50ug group.
And based on this data FDA gave full approval to the Pfizer vaccine under the brand name of Comirnaty.
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