FlyFisher09 said:
Doc - You may have commented on this before and I missed it, but do you have any perspective on the Moderna vaccine of which Fauci has claimed hundreds of millions of doses will be available early 2021? Isn't this much faster than originally projected? Do you any insight on your level of confidence in this vaccine clearing phase 3? Thanks!
There were some very good results from the phase 1 trial with the lowest dose producing an antibody response equal to that of a recovered COVID patient. Ideally, the goal of phase 3 is to show that people given the vaccine are less likely to get the virus than people in the control group. Given the antibody response from phase 1, it would be surprising if they don't achieve that goal.
The other concern would be side effects. Phase 1 only showed side effects with the highest dose (10x more than the lowest dose), although that was a group of healthy adults. More side effects may be observed in the larger phase 2 and 3 trials as well as trials of elderly or young patients. The question will be how severe and how common are those side effects. Given the side effects at the high dose were basically irritation and swelling at the injection site after the second dose, even if those side effects were more common in the further trials, emergency use authorization would still be likely.
A couple things changed from the initial claims of maybe the end of 2021 to now. 1) beginning production before phase 3 is complete cuts months off the schedule. 2) success in the phase 1 trial of the Moderna vaccine makes it more likely we do not need to wait for trials of another vaccine. 3) Moderna's vaccine is an mRNA vaccine and should be relatively fast to make.
mRNA vaccines have never been tested before so phase 1 success was a complete unknown back in March.
Also part of what takes so long to make things like the annual flu vaccine is the process to grow the virus used to make it. mRNA vaccine doesn't rely on growing a virus but rather synthesizing mRNA. On a small scale in a lab setting, one can make mRNA in less than an hour. Obviously scaling up to make hundreds of millions of doses will take time, but Moderna's partner is already working on getting multiple facilities ready for production.