Nacho Libre

Emergency Use Authorization.

tlove482

That efficacy only has 3 weeks of data which isn't much time to contract covid whether you have a vaccine or not.

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BoilerUP

Correct...but when you put those three weeks of data side-by-side with placebo results efficacy is easy enough for a caveman to see.



That being said, I can understand why a decision has been made to stick to what was trial-tested.

rickair7777

Some clinical trials are time-driven, such as chemo-therapy where you want to see how long it works.

The efficacy part of vaccine trials are event-driven... once you get X number of infections in the control group you're good. You just compare that to Y number of infections in the vaccine group to get your efficacy.

The number you need for X is actually pretty low, about 100 will do and the size of the trial group is irrelevant. 100 infections in the control, and 98 infections in the vaccine group is an efficacy fail. 100 control, and 4 vaccine is a resounding success.

Running very large trails (30-60K in the case of covid) does two things. First, it gets your control infections sooner. You *could* do a control group of 100 people, but you'd need to wait for ALL of them to get covid to get your number... despite all the media hype covid is still not that common. You could also hypothetically do a very small "challenge" trial, where you would deliberately expose to covid 100 each placebo and vaccine recipients... obvious ethical issues, but it's been done with non-lethal bugs before. J&J initially sized their stage 3 trial at 60K, but reduced it because of the covid surge... didn't need that many people to get timely results since covid is now more readily "available" than when they planned the trials last summer.

That's efficacy. Trail size is based on pathogen prevalence & contagiousness, and how quickly you need to get X infections in the control group. In the case of covid they wanted the data asap. You can certify the vaccine if efficacy and safety are good at that point.

Other aspects of trials are safety and duration of efficacy. A large trial group gives better confidence in safety. It also ensures that you'll have enough participants who stick with the monitoring programming long enough to get longer-term data on both efficacy duration and safety.

tlove482

In my opinion, a challenge trial is the only real way to figure out true efficacy. How can you say how effective it is unless you know who was exposed to the virus?

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rickair7777

Statistics. If you 100 infections in the placebo group you can safely assume that right about 100 people in the vaccine group would have been exposed and infected in the same time period, all things being equal (which they're not, because of the vaccine).

This assumes random allocation of placebo/vaccine among the volunteers to ensure that both groups are distributed in the same general environment, but that's how they do these trials.

To get 100 exposures and infections in a given size control group while having zero exposures in the vaccine group would be statistically so unlikely as to be impossible for practical purposes. You can study up on the math, or just look at the numerous previous vaccine trails which have resulted in successful products.

rickair7777

CDC states the obvious, that priority groups will overlap...

https://www.reuters.com/article/us-h...-idUSKBN29D21E

deltajuliet

Earlier somebody posted wording suggestive of pilots being 1C. Has there been any further clarification, or has anybody received company guidance, or a letter from their company to take to an immunization center saying they’re essential or something along those lines? Maybe an ALPA email I missed? Or is this entirely in the hands of your locality?

poorflyer

I believe it’s done by state. Near me NY has included public transport in 1b, but NJ is not until a later phase of 1b even though they are accepting registration for some 1b qualified people.

highfarfast

I just wanted to add, don't wait for your company to tell you when to take it if you want it. Just for anecdotal reference, my company has sent out two emails with 'guidance'. Neither really encouraged taking the vaccine. Instead it basically reminded us if we take the vaccine to do it on our own time and to remember to factor in the 48 hour no-fly window mandated by the FAA AND that they don't have staffing to cover people taking time off to do this (the first while pilots were furloughed without pay, the second after the furloughed pilots had started getting P2P but still not really called back to work).

The county were I live, you have to register for the vaccine with a little question and answer survey for them to know where to place you in the que.