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uponit7771

(90,225 posts)
Mon Nov 16, 2020, 04:42 PM Nov 2020

Anyone else looking at the Modera and Pfizer Vaccine pressers? They're not very controlled at all

Last edited Mon Nov 16, 2020, 05:53 PM - Edit history (1)

... and claiming efficacy based on what did not happen to an uncontrolled group doesn't give me confidence.

That's like saying a person doesn't get bit by pink gators cause they're republican, sending them out in public and then no pink gators bite them and claim voting republican is 100% effective against pink gators.

Any one else see any specific data in the pressers to show there was a controlled process for infections vs random?

thx in advance

EDIT: There are greater controlled infection studies called Human Challenges here - LINK that allow for a group of people to be infected voluntarily.



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Anyone else looking at the Modera and Pfizer Vaccine pressers? They're not very controlled at all (Original Post) uponit7771 Nov 2020 OP
There's no other way to do human studies for Phoenix61 Nov 2020 #1
Yes they can, give my family 5 million if I die or get disabled & free education I'll think about uponit7771 Nov 2020 #6
No, they can't. Turin_C3PO Nov 2020 #13
Not if they volunteer, 14,000 for human challenge (link inside) uponit7771 Nov 2020 #38
No ethical doctor would deliberately infect Phoenix61 Nov 2020 #14
No, they're doing human challenge studies here and in Europe. 14,000 already signed up here (link) uponit7771 Nov 2020 #39
No, they aren't. Phoenix61 Nov 2020 #48
I remember this story about the doctor who let a mosquito bite him & got Yellow Fever and died liberal_mama Nov 2020 #33
Yes, they were well-controlled. MineralMan Nov 2020 #2
The person speaking about Moderna on CNN claimed there was no controlled infection process ... uponit7771 Nov 2020 #3
No study can challenge subjects by deliberately exposing them to the virus. MineralMan Nov 2020 #7
They are about to do a human challenge trial in the UK ... rog Nov 2020 #31
+1, I think the number in the US is up to 14,000 already. Give them extra if they live or not uponit7771 Nov 2020 #36
Yes they can if the people volunteered link inside uponit7771 Nov 2020 #35
That was a really good article ... rog Nov 2020 #46
"both placebo group and the non placebo group both got sick but they got sick at different levels" Orangepeel Nov 2020 #15
"Usually, they will try to statistically control for other factors" True, I'm thinking they would've uponit7771 Nov 2020 #40
What you call a "controlled infection process" is very rare, and not what "control" means in tests muriel_volestrangler Nov 2020 #22
Correct, but there are 14,000 volunteers so far for human challenge. Seems like this vaccine would uponit7771 Nov 2020 #37
This - the normal kind of test - achieves different things muriel_volestrangler Nov 2020 #45
Agreed -- risk analysis or anything to strengthen claims would be nice JT45242 Nov 2020 #4
+1, "engaged in equally risky behavior." after hearing the women on CNN my jaw dropped cause the uponit7771 Nov 2020 #5
+1 Laelth Nov 2020 #8
Dexamethasone, while disagreeable to take due to moonscape Nov 2020 #20
I'm listening to the Moderna doctor and I can't believe what I'm hearing !! He's basically saying uponit7771 Nov 2020 #11
It means vaccine prevented covid in 95 % of people who got the vaccine. LisaL Nov 2020 #18
We'd have to assume the risk behavior etc etc among the two groups are equal enough ... uponit7771 Nov 2020 #28
So, yeah, they were "so wide swathed socio economically" muriel_volestrangler Nov 2020 #24
Absolutely, that's way the hell too narrow for medical vaccine. OMG, thats prelim data for further uponit7771 Nov 2020 #29
It's the number the FDA decided on a long time ago muriel_volestrangler Nov 2020 #47
It doesn't mean that at all. Disaffected Nov 2020 #30
That would assume the risk behavior etc among the groups is wide enough. I can see how this is ... uponit7771 Nov 2020 #41
People were randomly split into two groups. LisaL Nov 2020 #9
The pressers don't show delta's between the two groups that are socio economic etc uponit7771 Nov 2020 #17
Nobody would do clinical trial like that. LisaL Nov 2020 #19
Do you believe they should intentionally infect people with a deadly disease instead? Statistical Nov 2020 #10
Only if the people volunteered like have been done in human challenge studies (link inside) uponit7771 Nov 2020 #32
Many experts I respect Turin_C3PO Nov 2020 #12
+1 lunasun Nov 2020 #16
All the experts I respect are waiting on peer reviewed data which we don't have, just a presser uponit7771 Nov 2020 #21
For how long does one have immunity? I think I read moonscape Nov 2020 #23
I sincerely doubt that. LisaL Nov 2020 #25
You doubt what? Laurie Garrett, author moonscape Nov 2020 #27
The "good" news genxlib Nov 2020 #26
Hmmm, true but wouldn't that push both groups to go into higher NPI levels? Vaccine or not uponit7771 Nov 2020 #34
That is sort of the idea genxlib Nov 2020 #42
Right, I think my issue is the filing for EUA based off the 95 people so far but if it was 500 to uponit7771 Nov 2020 #43
Agreed genxlib Nov 2020 #44
That's a whole other issue with me, we can do what Thailand, Australia, S Korea or a number of other uponit7771 Nov 2020 #50
You are wrong, do more research! nt USALiberal Nov 2020 #49

Phoenix61

(16,950 posts)
1. There's no other way to do human studies for
Mon Nov 16, 2020, 04:44 PM
Nov 2020

a vaccine. It’s not like they can intentionally expose them to the virus.

uponit7771

(90,225 posts)
6. Yes they can, give my family 5 million if I die or get disabled & free education I'll think about
Mon Nov 16, 2020, 04:56 PM
Nov 2020

... doing it myself.

Phoenix61

(16,950 posts)
14. No ethical doctor would deliberately infect
Mon Nov 16, 2020, 05:03 PM
Nov 2020

someone with a disease. Any research from such an experiment wouldn’t be accepted.

Phoenix61

(16,950 posts)
48. No, they aren't.
Mon Nov 16, 2020, 06:25 PM
Nov 2020

“There are no public plans for such a study in the U.S., but politicians and volunteers are pushing for one. More than 14,000 willing study participants have organized an advocacy group, and 35 members of Congress recently asked regulators to consider human challenge trials. Across the Atlantic, some European companies are working to launch challenge studies, and the World Health Organization recently released a working document outlining criteria for an ethically acceptable design.”

liberal_mama

(1,495 posts)
33. I remember this story about the doctor who let a mosquito bite him & got Yellow Fever and died
Mon Nov 16, 2020, 05:29 PM
Nov 2020

Jesse Lazear (1866-1900), American physician and U.S. Army Yellow Fever Commission member, traveled to Cuba in 1900 to study the disease. Lazear was convinced that the best available evidence suggested a living host for yellow fever. Determined to uncover the source of the illness, Commission members decided to test the theory of mosquito transmission. Lazear hatched mosquito eggs and let the mosquitoes feed on patients infected with yellow fever at a Havana hospital. The mosquitoes were then allowed to feed on study volunteers, and they fell ill with yellow fever. These experiments validated the theory that mosquitoes (specifically, the Aedes aegypti variety) were the transmission vector of yellow fever. The researchers went on to rule out a bacterium as the disease agent. They determined that an infectious particle too small to be filtered with a standard bacterial filter was the source of the disease: the first human virus ever discovered. (German scientists had identified the virus that caused foot-and-mouth disease in animals in 1898.) The two men Lazear exposed to yellow fever via the experiment’s mosquitoes recovered. Lazear himself, however, was not so lucky. It is likely that he allowed himself to be bitten as part of the experiment. Lazear contracted yellow fever and died in September 1900, at age 34.

https://www.historyofvaccines.org/content/jesse-lazear

uponit7771

(90,225 posts)
3. The person speaking about Moderna on CNN claimed there was no controlled infection process ...
Mon Nov 16, 2020, 04:52 PM
Nov 2020

... that they just send people out in the public to get the virus after being vaccinated and that's it.

Also, the doctor speaking on the subject said both placebo group and the non placebo group both got sick but they got sick at different levels.

Can you outline the control for the infection process? I don't see them in the pressers I could be missing them totally.

Thx in advance

MineralMan

(146,190 posts)
7. No study can challenge subjects by deliberately exposing them to the virus.
Mon Nov 16, 2020, 04:56 PM
Nov 2020

All you can do is see how the treated and control groups do with typical natural exposure. No physician would deliberately expose someone to the COVID-19 virus. At least no physician not part of Hitler's regime.

The control group did not receive the vaccine. The test group did. Neither group knew whether they had received the vaccine or not. That is a classic controlled study. That is how vaccine research is done.

rog

(647 posts)
31. They are about to do a human challenge trial in the UK ...
Mon Nov 16, 2020, 05:23 PM
Nov 2020

... per Richard Engel, in his special on Covid-19 last night on MSNBC.

I didn't search far, but here is some print info that may be helpful.

https://www.nature.com/articles/d41586-020-02821-4

Dozens to be deliberately infected with coronavirus in UK ‘human challenge’ trials

Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of vaccines that could end the pandemic.

Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the virus SARS-CoV-2 that could be used in future vaccine trials. But the prospect of deliberately infecting people — even those at low risk of severe disease — with SARS-CoV-2, a deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory.


.rog.

Orangepeel

(13,933 posts)
15. "both placebo group and the non placebo group both got sick but they got sick at different levels"
Mon Nov 16, 2020, 05:03 PM
Nov 2020

the control group is the group that got the placebo.

If the sample size is large enough, it is randomly determined whether someone got the vaccine or the placebo, and people didn't know which they got, it is assumed that other factors evened out and the difference in rates of sickness between the groups was due to the vaccine.

Usually, they will try to statistically control for other factors, but that's the basic story of how experiments are done.

uponit7771

(90,225 posts)
40. "Usually, they will try to statistically control for other factors" True, I'm thinking they would've
Mon Nov 16, 2020, 05:48 PM
Nov 2020

... put these controls in the pressers after asking for an EUA.

We'll see

muriel_volestrangler

(101,149 posts)
22. What you call a "controlled infection process" is very rare, and not what "control" means in tests
Mon Nov 16, 2020, 05:07 PM
Nov 2020

I suspect you're thinking of a "challenge" process:

Human challenge studies provide a faster way to test vaccines because you don't have to wait for people to be exposed to an illness naturally.

Researchers would first use controlled doses of the pandemic virus to discover what is the smallest amount that can cause Covid infection in volunteers aged 18 to 30.

These human guinea pigs, who will be infected with the virus through the nose and monitored around the clock, have the lowest risk of harm due to their young age and good health.

Next, scientists could test if a Covid vaccine prevents infection.

https://www.bbc.co.uk/news/health-54612293

Very rare to do this with a disease that has serious consequences, as the article notes.

"just send people out in the public to get the virus after being vaccinated and that's it" is normal for phase 3 trials. You vaccinate some, give some a placebo, and see how many of each get infected in normal life. The "control group" is the ones with the placebo; you compare their rate of infection (for whom you have done nothing) with thoser who got the real vaccine.

uponit7771

(90,225 posts)
37. Correct, but there are 14,000 volunteers so far for human challenge. Seems like this vaccine would
Mon Nov 16, 2020, 05:39 PM
Nov 2020

... be a good candidate for such if the peer reviewed data looks good.

muriel_volestrangler

(101,149 posts)
45. This - the normal kind of test - achieves different things
Mon Nov 16, 2020, 06:15 PM
Nov 2020

This gives an idea of the actual protection you're concerned with - catching it via real world scenarios. They have to closely monitor people in challenge trials; the number of volunteers doesn't matter, it's the capacity and budget for running it.

JT45242

(2,173 posts)
4. Agreed -- risk analysis or anything to strengthen claims would be nice
Mon Nov 16, 2020, 04:53 PM
Nov 2020

Both companies could easily have supplied a biotracker or phone app to monitor data like

1) number of times they left their property
2) amount of time spent outside of the home
3) required logs of how many people that participants interacted with by day

The drug companies appear to be operating on the impression that all participants engaged in equally risky behavior.

I did a lot of studies for Proctor and Gamble and we had to log everything about the product -- for example, we weighed diapers, filled out Likert sheets on every diaper used as to leaks, marks on skin, etc. It would seem that with a vaccine that they could get some actual data on these people.

Of course, this is all prelim data ... good for a quick stock boost but let's see if it works in reality.

I am not in a rush to get in line for the FIRST CORONAVIRUS VACCINE TO EVER WORK...

I am hopeful that a vaccine that would not require tens of billions of cryogenic storage upgrades for trucks, hospitals, pharmacies, etc will work. I would just like a lot more published data before I feel like this is actually working.

Not that big Pharma would ever put profits before probably conducting safety trials...

uponit7771

(90,225 posts)
5. +1, "engaged in equally risky behavior." after hearing the women on CNN my jaw dropped cause the
Mon Nov 16, 2020, 04:54 PM
Nov 2020

... non risky behavior could be outlined by tons of social economic factors that expose different people to the virus at different rates etc.

Laelth

(32,017 posts)
8. +1
Mon Nov 16, 2020, 04:58 PM
Nov 2020

Frankly, I am far more interested in effective treatments than I am a vaccine. So far, Dexamethasone is the only proven-effective treatment we have, and that stuff is really dangerous.

-Laelth

moonscape

(4,664 posts)
20. Dexamethasone, while disagreeable to take due to
Mon Nov 16, 2020, 05:06 PM
Nov 2020

side effects, is not dangerous. It's a common drug in chemo cocktails for the cancer I have, and I've never heard of someone having lasting bad effects from it. I'm in forums about my cancer, nearly every person had it as part of their induction therapy without an issue beyond it's not fun to have sleepless nights, altered mood, etc.

We had to take high doses of it for months (sometimes 6) and as covid therapy it would be very short duration.

uponit7771

(90,225 posts)
11. I'm listening to the Moderna doctor and I can't believe what I'm hearing !! He's basically saying
Mon Nov 16, 2020, 05:01 PM
Nov 2020

Last edited Mon Nov 16, 2020, 05:45 PM - Edit history (1)

... 95 people got the virus but only 5 were from the vaccine group.

WTF !?!!

That doesn't mean shit unless the 30,000 were so wide swathed socio economically etc for instance for that not to be factor.

EDIT: Looks like this is prelim data, they're going to come out with a lot more to be peer reviewed before requesting an EUA, just wish they would expose the risk analysis etc etc data in the presser .... I don't see it.

LisaL

(44,962 posts)
18. It means vaccine prevented covid in 95 % of people who got the vaccine.
Mon Nov 16, 2020, 05:05 PM
Nov 2020

Thus vaccine is 95 % effective.
By the way if you don't want the vaccine, I don't think anyone is going to make you get it.

uponit7771

(90,225 posts)
28. We'd have to assume the risk behavior etc etc among the two groups are equal enough ...
Mon Nov 16, 2020, 05:19 PM
Nov 2020

... not to be a factor.

Its good news for further study but I don't see it being enough data for EUA for fast distribution for a NEW vaccine, seems like that's pretty risky.

muriel_volestrangler

(101,149 posts)
24. So, yeah, they were "so wide swathed socio economically"
Mon Nov 16, 2020, 05:11 PM
Nov 2020

Is that so hard to believe when you have 30,000 people?

uponit7771

(90,225 posts)
29. Absolutely, that's way the hell too narrow for medical vaccine. OMG, thats prelim data for further
Mon Nov 16, 2020, 05:21 PM
Nov 2020

... study but not for EUA for a new vaccine to go to hundreds of millions of people.

muriel_volestrangler

(101,149 posts)
47. It's the number the FDA decided on a long time ago
Mon Nov 16, 2020, 06:25 PM
Nov 2020
Four candidate vaccines selected by Operation Warp Speed now are in efficacy trials, which are comparing the incidence of COVID-19 disease in at least 30,000 participants who blindly receive either a vaccine or a placebo. They are designed to end when they have about 150 cases of symptomatic disease, but independent monitoring boards will tell investigators whether a vaccine looks like it’s working at 50 cases and again at 100 cases. FDA guidance issued in June says the agency will consider issuing an EUA for a vaccine if it shows at least 50% efficacy at any of these analyses.

https://www.sciencemag.org/news/2020/10/there-s-only-one-chance-do-right-fda-panel-wrestles-covid-19-vaccine-issues

Disaffected

(4,503 posts)
30. It doesn't mean that at all.
Mon Nov 16, 2020, 05:22 PM
Nov 2020

Please refer to MineralMan's post (#7) for an explanation of how it works.

They key is the large number of test subjects chosen. The assumption (valid) is that the various individual factors such as age, health status, economic status etc. will average out over such a large number of participants.

The 95% means that of those 30,000 who participated (vaccine receivers and controls), 95% of those who contracted the virus were in the control group and 5% were in the vaccine receiver group - a most excellent outcome by any measure.

Even better, they are claiming that, of those who contracted the virus, none were considered to be cases of serious illness (100% efficacy for that measure).

uponit7771

(90,225 posts)
41. That would assume the risk behavior etc among the groups is wide enough. I can see how this is ...
Mon Nov 16, 2020, 05:49 PM
Nov 2020

... promising I don't see how these companies would ask for EUA for it though.

LisaL

(44,962 posts)
9. People were randomly split into two groups.
Mon Nov 16, 2020, 05:00 PM
Nov 2020

One group got placebo (control group), the other got the vaccine.
So, yes, they had a control group.
I am assuming the two groups were similar to each other such as age, race, gender and so on.

uponit7771

(90,225 posts)
17. The pressers don't show delta's between the two groups that are socio economic etc
Mon Nov 16, 2020, 05:04 PM
Nov 2020

... and yes, that needs to be factored in.

One group are front line workers for instance the other group not so much, that would explain the difference in infection rate too.

Statistical

(19,264 posts)
10. Do you believe they should intentionally infect people with a deadly disease instead?
Mon Nov 16, 2020, 05:00 PM
Nov 2020

They have a vaccinated group and a control group. Double blind. Nobody knows if they are vaccinated or not. The vaccinated group has a statistically lower rate of infection than the control group.

Short of being a murdering sociopath how would you recommend they conduct the trial?

uponit7771

(90,225 posts)
32. Only if the people volunteered like have been done in human challenge studies (link inside)
Mon Nov 16, 2020, 05:27 PM
Nov 2020
https://www.nbcnews.com/health/health-news/why-have-14-000-people-volunteered-be-infected-coronavirus-n1203931

We'll see, just heard the Moderna tech say they're looking forward to paneled peer review on the rest of their data.

That's were EUA's get held back

uponit7771

(90,225 posts)
21. All the experts I respect are waiting on peer reviewed data which we don't have, just a presser
Mon Nov 16, 2020, 05:06 PM
Nov 2020

... showing an random / uncontrolled infection process between two groups.

moonscape

(4,664 posts)
23. For how long does one have immunity? I think I read
Mon Nov 16, 2020, 05:10 PM
Nov 2020

the study hadn't addressed further out than 7 days.

moonscape

(4,664 posts)
27. You doubt what? Laurie Garrett, author
Mon Nov 16, 2020, 05:17 PM
Nov 2020

of _The Coming Plague_ and a science journalist contributer on MSNBC said this when the study came out. I don't know if there has been more data on this in the last weeks.

If you doubt it's only 7 days, sure. The point isn't that it's only 7 days, but that how long the immunity from the vaccine is at this point isn't known.

Just one of the still-open questions.

genxlib

(5,506 posts)
26. The "good" news
Mon Nov 16, 2020, 05:17 PM
Nov 2020

Is that they should get a lot more data in the next couple of weeks. With COVID rampant in the community, the number of cases in the study group will go up. And that will clarify the effectiveness more.

It isn't good news that we have a lot of infection out there but it will definitely help to tell if the vaccine is working.

uponit7771

(90,225 posts)
34. Hmmm, true but wouldn't that push both groups to go into higher NPI levels? Vaccine or not
Mon Nov 16, 2020, 05:31 PM
Nov 2020

... I wouldn't want to look to getting CV19 not knowing if I'm in the placebo group or not.

We'll see, I just wish they released more standard data on the two groups.

genxlib

(5,506 posts)
42. That is sort of the idea
Mon Nov 16, 2020, 05:58 PM
Nov 2020

Neither group is looking to get it.

But like all of us, they are exposed to some degree as they go about their life. More community spread means more chance of exposure.

The idea is that both groups will get exposed. The non-vaccinated group will catch it while the vaccinated group won't.

Currently they have under 100 positives. The 95% number comes from how many of those are in the non-vaccinated group. The statistical assurance of that methodology gets better as the numbers go up. If they end up with 500 positives and they are still coming from the no-vaccine group at a 95% rate then the number is certainly more believable.

uponit7771

(90,225 posts)
43. Right, I think my issue is the filing for EUA based off the 95 people so far but if it was 500 to
Mon Nov 16, 2020, 06:01 PM
Nov 2020

... 1000 then that's a pretty big result.

Still needs to be time tested but would look more promising imho

genxlib

(5,506 posts)
44. Agreed
Mon Nov 16, 2020, 06:09 PM
Nov 2020

The only good thing is with a high end result of 95%, even if the statistical confidence is low, it could still represent a high enough value to make it effective. ie +/- 20% error margin still makes it 75% effective which was what they were looking for going in.

It is kind of the nature of being an emergency that will require it to be authorized with limited data

uponit7771

(90,225 posts)
50. That's a whole other issue with me, we can do what Thailand, Australia, S Korea or a number of other
Mon Nov 16, 2020, 06:59 PM
Nov 2020

... countries are doing that have effectively controlled CV19 and not "rush" a new vaccine bypassing time testing for side effects.

I'll still sit on the sideline waiting for a while, I Am Legend comes to mind

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