I have rethought my initial “WOW WOW WOW” response to the blank Package Insert. What goes into a Package Insert arises from a prolonged negotiation with the regulatory agency (FDA in the US) from the licensure trials as well as the peer-reviewed literature. Every graph, every table, every comma, every WORD. Only the verbiage in the PI can be used for sales and promotion. Since these therapies are all available under EUA, this process has not taken place yet.
I have not had first hand experience handling the drug products for a trial, but kinda recall something in the cobwebs from discussions with colleagues that the Package Insert information is blank, as a placeholder for future labelling.
Excellent analysis and info!