The drug exists, but not the legally distinct product that received FDA approval. FDA mentioned this in their statement, so it's not playing semantics. They need to provide a complete list of ingredients, a list of risks (at least Myocarditis and Thrombosis), receive acceptance from FDA on those, and then package and ship.

I don't know if there is less liability immunity with the approved version if/when available. Long-term trials, including for pregnancy effects will be "complete" 2025, and 2027. I put that in quotes, because they halved the current trial.

The drug exists, but not the legally distinct product that received FDA approval. They need to provide a complete list of ingredients, a list of risks (at least Myocarditis and Thrombosis), receive acceptance from FDA on those, and then package and ship.

I don't know if there is less liability immunity with the approved version if/when available.