4 ms·
Based on a podcast I heard this week FDA approval also looks at quality assurance of mass manufacturing, storage, supply chains, etc. It’s not just about effica
by jpster 5y ago
Based on a podcast I heard this week FDA approval also looks at quality assurance of mass manufacturing, storage, supply chains, etc. It’s not just about efficacy and safety of the formulation, itself, but whether they can be assured at scale. It takes time to check all those boxes.
- Throwawayaerlei 5y agoThat's required to get an Emergency Use Authorization (EUA), is supposed to be why Novavax is behind schedule due to other cell culture based manufacturers soaking up resources, and why Emergent BioSolutions has never gotten approval for their Baltimore plant to make Janssen doses. Was in fact shut down, AZ/Oxford production at it canceled, etc. As I understand it the rolling reviews for mRNA vaccine approval are purely a matter of time to prove for real the length of efficacy of them, that's part of the risk/benefit analysis. Can only be done a day at a time....