>>13843239That isn't typically how the standard is set. Medicines like this are not held to a standard of necessarily of developing some mechanism, but is monitored through safety data which comes in the application. It is not acceptable to say a drug is safe just because "i don't know of a side effect."
As for a direct question about LNP my understanding is that manufacturers, Moderna and Pfizer, developed their own delivery package for the mRNA. I don't know how much of that is proprietary, but processes are all likely to be. You could speculate on how other lipids behave in the blood stream, but that may not be very accurate depending on how it is made. SM-102 is one lipid in moderna that got some heat, but which toxicity is traced by to the chloroform it is kept in solution. One would correctly anticipate that tight controls are required to ensure solvents and other hazardous materials do not end up in drugs. There is no guarantee on these controls beyond their validation, whatever that includes, and the success of that validation. One example, from a completely different field, is failure to maintain public water profiles because of contaminants during fluoridation, where arsenic and other chemicals are outside of safety margins, particularly when measured near fluoridation site. The point is that even important, well monitored, supposedly well understood, process activities can have unanticipated consequences. More backrooms and less transparency only hurts the situation. The Pfizer Ventavia leak is a big concern when it comes to this.
