3 ms·
There is no safety difference between a EUA and a standard authorization. In fact, the opposite of your assertion is probably true - the safety and efficacy dat
by InTheArena 5y ago
There is no safety difference between a EUA and a standard authorization. In fact, the opposite of your assertion is probably true - the safety and efficacy data of the mRNA vaccines in particular is far far far in excess of what we have had with other things the FDA has approved. If you want to get up in arms, go read about the FDA approving Biogen’s aducanumab, which has serious safety issues, and no proven efficacy. It's a 50k a year hand out from medicare to a pharma company.
The process the vaccines are going now is updating their rolling submissions to cover all the data since the EUA. What the EUA gave them was really the ability to do the paperwork for general, and start scaling the factory before the phase 3 trials where complete.
source:
https://vaccine.unchealthcare.org/science/vaccine-approval/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/ https://vaccine.unchealthcare.org/science/vaccine-approval/w...
There is a great diagram there that shows the processes.