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by blindriver3
2 hours ago
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No, they included only data from a study of 50+ year olds using a lower dose. But 65+ year olds don't use the lower dose flu shot. They ONLY use the higher dose for 65+ so why would the review go forward without this data? Why review a drug where we don't know how effective they are vs the standard treatment for the main group of adults (65+) that need it the most? > Moderna acknowledged that FDA scientists had previously suggested that the company use a recommended high-dose flu vaccine in trial participants 65 and older. But the agency ultimately signed off on the trial design with the uniform standard dose, calling it “acceptable.” Moderna, meanwhile, agreed to add a comparison of a high-dose vaccine to some older participants and provide the FDA with additional analysis. FDA previously suggested to use the higher dose vaccine as comparison for 65+ but for some reason they backed off it. Who knows why, but Prasad did the right thing. And Moderna added the data and now everyone is happy. Are you saying that multi-billion dollar drug companies should just get a rubber stamp? What Prasad demanded was spot on, which is make sure that the trials include the group of patients that need it the most against the standard, high-dose flu vaccine. Again, explain to me why this is wrong? |
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