Forums >Health and Nutrition>The COVID-19 Wild West Thread
My understanding is that none of these vaccines have released peer reviewed data simply because they're not at that point yet, not because of anything nefarious. Basically with the help of warp speed and other government backed initiatives around the world, all of these drug companies have been able to "de risk" the research and go way faster than would be normally possible, essentially going straight from phase 1 to phase 3 which a drug co would never do if it had to assume the financial risk on its own. Typically it takes 10 years and a billion dollars to bing a vaccine to market.
That podcast I posted above is long but it does a decent job explaining it a way that I, a non scientist, found accessible.
Runners run
Those little viruses will be checking their watches.
So there is a shred of reason to the 10pm closing. Our governor also used his press conference to beg the feds to pass a relief bill. I think he is trying to keep them open until a relief bill passes. I suspect if/when a relief bill passes, bars & restaurants go to carry out only the next day.
Good Bad & The Monkey
So you know you're getting the vaccine and not placebo? (You probably explained this further back.)
Oh yea. I had side effects you don't get from injected saline.
What are the side effects like? sick for a week? muscle aches? metallic taste in your mouth? Itchy skin?
There are two doses. After the first, I had some aches in my arm the first day, then went to bed for the night. I slept almost 15 hours and all the next day I could barely stay awake. But I had a 50k the following day, so I drank some espresso, drove to the race / hotel. Boy, I've never slept that well before a race. Anyhow, the next day, two days after the vaccine, I could barely stay awake and I could barely run. So I waked 30 miles. I had some achiness for several days after that, different than what I would expect from all that walking.
After the second dose, I expected to be sleepy. Instead, I developed a 9 out of 10 crushing headache, fever that went as high as 102.7 despite 600 mg ibuprofen, major arm swelling for several days, and just achiness. I also had a persistent weakness that impacted running and energy for about two weeks.
I understand that these side effects are fairly common, although mine have been worse that most. That is, lots of folks get fever but usually not as high as mine was. If that is true, the side effects may also limit vaccine uptake.
I'm running somewhere tomorrow. It's going to be beautiful. I can't wait.
Poor baby
Sure, and vaccines can get an EUA before peer review.
But a data safety monitoring board is different than peer review. For every randomized controlled trial, especially of a new drug, treatment, vaccine, etc, you bring in an external review board that periodically looks at the data. Their job is to determine if it is ethical for the trial to continue. Reasons it may not be ethical to continue include:
- if beyond a shadow of statistical doubt it appears that the drug will be better than placebo, then it is no longer ethical to withhold the drug for the duration of the planned trial.
- if beyond a shadow of statistical doubt it appears that the drug will be NO better than placebo, then it is no longer ethical to give the drug for the duration of the planned trial.
- if beyond a shadow of statistical doubt it appears that the drug is less safe than the placebo, then it is no longer ethical to give the drug.
The major remdesivir trial was halted early by its data safety and monitoring board because the analysis revealed that there was not going to be an improvement in rates of death BUT there were improvements in hospitalization duration. Those initial findings from the halted trail have been borne out in real world experience that has followed.
My understanding is that none of these vaccines have released peer reviewed data simply because they're not at that point yet, not because of anything nefarious..
RIP Milkman
This is not true regarding confidence intervals. If the vaccine was 50% effective, you may have a point, but at 95% effective with this sample size AND two different vaccine trials showing almost nearly identical effectiveness, there is absolutely no doubt that the vaccine is going to be very effective. Will it be exactly 95%? Probably not. But even if it's 80% effective, this is phenomenal news and clearly we are on the path towards inoculation. Please do not fear monger and say nonsense things like this is just to boost stock prices. Even in a wild wild west thread, this is irresponsible coming from an MD.
Pfizer initially announced last week and Moderna on Monday. Regardless, the news is incredibly premature. We are only three months into their Phase 3 trials, only fewer than 100 cases out of tens of thousands inoculated vaccine or placebo. The confidence intervals around the estimates of effectiveness are still way too wide to make anything of this news.
Pfizer initially announced last week and Moderna on Monday.
Regardless, the news is incredibly premature. We are only three months into their Phase 3 trials, only fewer than 100 cases out of tens of thousands inoculated vaccine or placebo. The confidence intervals around the estimates of effectiveness are still way too wide to make anything of this news.
5K: 16:37 (11/20) | 10K: 34:49 (10/19) | HM: 1:14:57 (5/22) | FM: 2:36:31 (12/19)
Sure, and vaccines can get an EUA before peer review. But a data safety monitoring board is different than peer review. For every randomized controlled trial, especially of a new drug, treatment, vaccine, etc, you bring in an external review board that periodically looks at the data. Their job is to determine if it is ethical for the trial to continue. Reasons it may not be ethical to continue include:
So then it's safe to assume both of these drugs are getting periodic review of their data by an external review boards, right?
#artbydmcbride
Aren't they also reviewing side effects, as well as 'effectiveness'?
Yep. They really have to if they are to conduct a randomized controlled trial. FDA requires it.
Yes.
Fever to 102.7 is not considered a dangerous side effect.
Yes. Fever to 102.7 is not considered a dangerous side effect.
But it does make you 0.3 away from being Hot Blooded.Check it and see.
Nor should it be, at least according to Dr. Paul Offit on that podcast I referenced above.
undue monkey
The base sizes of the test and control group are not the same as the base sizes of cases to analyze. We have no idea how many of the 44,000 were exposed. We have no idea if those who were exposed to COVID and protected by the vaccine are representative of all risk factors in the larger population. This is great news for sure, but a lot of work is left to be done.
Right. But it is still uncomfortable AF
Yea, this.
We don't know if 22k were exposed or 5 were exposed in the vaccine group. If only 5 were exposed and those 5 are the same as the 5 who got sick, then the vaccine has 0% effectiveness.
Over time, as data accrues, we will know better.
Correct. That would potentially take years to solve, and perhaps never, which is why those who have any potential side effect risk should not take the vaccine right away. Once you break down the samples into small enough sizes to cover every possible risk factor in the population, credibility becomes nearly impossible. My point was more around the fact that Trent was announcing that the confidence intervals are wide for overall effectiveness and this was just a ploy to boost stock prices is not correct.