> Because the change is small, an updated vaccine doesn’t need Phase III trials and/or regularity approval. So, this whole process should take a max of 6 weeks. This appears to be incorrect, Moderna says it needs 60 days to just get into trials ( https://twitter.com/megtirrell/status/1464225637590310938 ) . The FDA has not said what the approval process will look like, but its safe to say it will be non-zero
> It would take six weeks for researchers to go from “plugging new variants into the vaccine” to “make a new vaccine ready to go into people,” he said, but that does not account for the time it would take to have a drug approved. Weissman compared the process to the way the vaccines for the seasonal influenza are modified each time it circumnavigates the globe.
https://www.theguardian.com/society/2021/nov/26/biontech-say... BioNTech says it could tweak Covid vaccine in 100 days if needed
> BioNTech says it could produce and ship an updated version of its vaccine within 100 days if the new Covid variant detected in southern Africa is found to evade existing immunity.