Great post, but even he underestimates how obvious an approval decision it was. Vaccines have a strong safety and efficacy history. I think if you replace the

Great post, but even he underestimates how obvious an approval decision it was. Vaccines have a strong safety and efficacy history. I think if you replace the words "not approved" with "banned", the insanity of the vaccine ban is clear. Even though Congress has multiple times given.the FDA commissioner broad powers to approve during a pandemic, they opted to not do it. There needs to be legislation to ensure the next one goes better. Effectively, they need to remove the discretion part from the FDA. My favorite ideas are: (1) automatic EUAs for any vaccine candidates when a disease has over 1 in 1,000 chance of killing a group and the vaccine candidate is from a company who has had a drug approved in the last 10 years. (2) allowing people during pandemic to pay to be in a vaccine trial. I know many people who would have loved to be in a trial, but were not able. (This was the FDA doesn't have to say something is "authorized" so it seems more organizationally feasible.) (3) allowing human challenge studies to happen. (4) 1 gradual rolling study instead of separate studies. Gradually increase the number of people who can be tested, and stop of the safety profile looks bad, but watch all for efficacy outcomes. So vaccinate 10 in week 1, 100 in week 2, 1,000 in week 3, 10,000 in week 4, etc. There has only been 1 ever long term side effect reported (from a polio love virus vaccination of an immunocompromised person), so you really want to see short term effects. (5) also just increase the level of ambition. Trump should have proposed bills in congress to lift the vaccine ban. Biden's goal in his first 100 days is to vaccinate 100M (given that we are supposed to have about 240M doses delivered by then with already approved vaccines. This is a low bar, sort of like saying "I hope we don't just accidentally throw away most of the vaccine". His goal should be 50% vaccinated in the first 30 days or something.