Slyver, I hear you saying they are the same vax. Even if true, that’s irrelevant to the issue about getting FDA approval.

The vax that just received FDA approval, identified as Comirnaty, is ‘new’ and not manufactured in the US and therefore, the FDA approved it based on a less extensive paper trail regarding safety and adverse effects than the vax that was given the EUA and manufactured in the US and has a pretty sketchy safety record.

The FDA specifically did NOT appprove the vax that was manufactured in the US and had the EUA. So, even if they are essentially the same vax, the legal distinction is extremely important. If there were no serious safety issues with the US version of the vax, why go to the the trouble of manufacturing the same vax under a new name in another country? Because it appears the FDA is well aware of the serious safety concerns associated with the vax and doesn’t want to issue an approval for it. But, the FDA is willing to issue an approval for a rebranded Comirnaty vax because they will likely make sure it’s not available in the US and so when safety issues do start to arise, the FDA will have a factual basis to distance itself from backlash for giving approval to an unsafe vax that was manufactured in another country.

A little legal fuckery goes a long way. Yes, I am a lawyer.

Slyver, I hear you saying they are the same vax. Even if true, that’s irrelevant to the issue about getting FDA approval.

The vax that just received FDA approval, identified as Comirnaty, is ‘new’ and not manufactured in the US and therefore, the FDA approved it based on a less extensive paper trail regarding safety and adverse effects than the vax that was given the EUA and manufactured in the US and has a pretty sketchy safety record.

The FDA specifically did NOT appprove the vax that was manufactured in the US and had the EUA. So, even if they are essentially the same vax, the legal distinction is extremely important. If there were no serious safety issues with the US version of the vax, why go to the the trouble of manufacturing the same vax under a new name in another country? Because it appears the FDA is well aware of the serious safety concerns associated with the vax and doesn’t want to issue an approval for it. But, the FDA is willing to issue an approval for a rebranded Comirnaty vax because they will make sure it’s not available in the US and when the safety issues start to arise, the FDA will have a factual basis to distance itself from backlash for giving its approval to an unsafe vax.

A little legal fuckery goes a long way. Yes, I am a lawyer.

Slyver, I hear you saying they are the same vax. Even if true, that’s irrelevant to the issue surrounding FDA approval The vax given FDA approval, identified as Comirnaty, is not manufactured in the US and therefore, the FDA was legally able approve it based on a more limited review of the adverse effects than the vax that was manufactured in the US that was given EUA. The FDA specifically did NOT appprove the vax that has the EUA. And that legal distinction, even if they are essentially the same vax, is important because if there were no serious safety issues with the vax, why fo through the the trouble of manufacturing the same vax with a new name in another country? Because the FDA is aware of the serious safety concerns associated with the EUA vax and doesn’t want to issue an approval for it but the FDA is willing to issue an approval for the rebranded Comirnaty vax because when the safety issues start to arise, the FDA will claim plausible deniability.

A little legal fuckery goes a long way. Yes, I am a lawyer.