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Yo_Mama_Been_Loggin

(107,576 posts)
Tue Jun 30, 2020, 08:05 PM Jun 2020

FDA will require a covid-19 vaccine be at least 50 percent more effective than a placebo

The Food and Drug Administration said Tuesday that to win regulatory approval, any covid-19 vaccine will have to prevent disease, or decrease its severity, in at least 50 percent of the people who receive it.

The agency also said it would require drug companies to monitor the vaccine’s performance after approval for any emerging safety problems.

The agency issued guidance to vaccine developers in conjunction with testimony by FDA Commissioner Stephen Hahn and other health officials before the Senate Health, Education, Labor and Pensions Committee on how schools and businesses can safely reopen amid the pandemic.

The standards spelled out apply to full approvals. But many people believe a vaccine initially would be made available through a much lower standard for temporary approvals, through what’s called an emergency use authorization. The guidance said any decision on an emergency authorization would be made “on a case-by-case basis considering the target population, the characteristics of the product” and the available evidence, including clinical trial data on safety and effectiveness.

https://www.msn.com/en-us/health/health-news/fda-will-require-a-covid-19-vaccine-be-at-least-50-percent-more-effective-than-a-placebo/ar-BB169W8D?li=BBnb7Kz

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FDA will require a covid-19 vaccine be at least 50 percent more effective than a placebo (Original Post) Yo_Mama_Been_Loggin Jun 2020 OP
horrible headline. msn editor needs to go back to math class. unblock Jun 2020 #1
What has it been in recent annual flu shots does anyone know ? I wonder if the vaccine also lunasun Jun 2020 #2
A few nights ago on CNN with Elizabeth Cohen, Dr. Fauci said, marie999 Jun 2020 #3
Looking at the history of plague vaccines I will not be the first to take one. This is crazy, one.. uponit7771 Jun 2020 #5
Holy crap, history really is repeating itself! Initech Jun 2020 #7
Yes, that "dip" was high NPI the "second wave" was a vaccine that was great at fighting bacteria fro uponit7771 Jul 2020 #23
I am waiting for the full list of centers for the Moderna vaccine trials Steelrolled Jun 2020 #19
Be careful, the last 3 plague vaccines either paralyzed people (link) or were useless and caused ... uponit7771 Jul 2020 #24
Everyone has to make their own decisions Steelrolled Jul 2020 #30
What exactly is 50% more than nothing? world wide wally Jun 2020 #4
The placebo effect is not nothing. Voltaire2 Jun 2020 #6
Last I checked, zero divided by zero is still zero. Initech Jun 2020 #8
The placebo effect is non-zero. n/t Ms. Toad Jun 2020 #10
I think it is more significant in trials for drugs Steelrolled Jun 2020 #20
Nope. It is pervasive. Voltaire2 Jul 2020 #26
The placebo group often receives another vaccine DrToast Jul 2020 #29
You compare disease in those vaccinated to those non-vaccinated (placebo) DrToast Jun 2020 #17
Placebo is not non-vaccinated. Voltaire2 Jul 2020 #27
If you don't receive a vaccine, you are non-vaccinated DrToast Jul 2020 #28
Except that a significant response will be detected from the placebo group Voltaire2 Jul 2020 #31
That's interesting. Thanks for sharing. ecstatic Jul 2020 #34
Why are you trying to argue points I'm not making DrToast Jul 2020 #38
You appeared to be supporting the claim originally made that placebo has zero effect. Voltaire2 Jul 2020 #39
Halfway there. Ms. Toad Jun 2020 #9
The chatter of symptom reduction vaccines was worrisome. herding cats Jun 2020 #11
For something that has pretty standard symptoms, Ms. Toad Jun 2020 #12
All true about the far too varied symptoms and asymptote cases. herding cats Jun 2020 #13
Wouldn't that be factored out in the statistics? Steelrolled Jun 2020 #21
There are so many variations, Ms. Toad Jul 2020 #22
I'm not sure either, it would depend on the size of the Steelrolled Jul 2020 #32
This disease is unlike any other science has encountered before, Ms. Toad Jul 2020 #40
It's not hard to discern it DrToast Jun 2020 #14
If you are happy with that standard, have at it. Ms. Toad Jun 2020 #15
You'd rather get the full blown disease? DrToast Jun 2020 #16
No, but the risk of a new vaccine - potentially created to employ different strategies Ms. Toad Jun 2020 #18
+1, the uselessness of the 1918 Kansas flu "vaccine" is part of the cause of the uptick or uponit7771 Jul 2020 #25
Medicine has advanced a little since 1918. Steelrolled Jul 2020 #33
We still don't have a vaccine for aides or the cold but we have a vaccine for corona virus all of uponit7771 Jul 2020 #35
Don't blame you. Steelrolled Jul 2020 #36
I found a useful source for vaccine trial information written for the general public. Steelrolled Jul 2020 #37

lunasun

(21,646 posts)
2. What has it been in recent annual flu shots does anyone know ? I wonder if the vaccine also
Tue Jun 30, 2020, 08:48 PM
Jun 2020

would lessen severity of the illness like they claim with flu shots -even if you get sick it’s not as bad
Anyway is it ever gonna be near 100% ?

 

marie999

(3,334 posts)
3. A few nights ago on CNN with Elizabeth Cohen, Dr. Fauci said,
Tue Jun 30, 2020, 08:49 PM
Jun 2020

that a vaccine that is 70-75% effective and that probably only 70-75% of people will take it will not be enough.

uponit7771

(90,296 posts)
5. Looking at the history of plague vaccines I will not be the first to take one. This is crazy, one..
Tue Jun 30, 2020, 09:03 PM
Jun 2020

... of the reasons there was a resurgence of Kansas Flue in 1918 was people thought that rushed vaccine at that time worked but it didn't.

uponit7771

(90,296 posts)
23. Yes, that "dip" was high NPI the "second wave" was a vaccine that was great at fighting bacteria fro
Wed Jul 1, 2020, 12:14 AM
Jul 2020

... from the virus not the virus itself and gave people a false sense of hope.

I don't see this being different, 9 women can't make a baby in a month so I don't see how anything the vaccines are going to be wide use time tested safe in such short time.

After this vaccine there should be no cold medicines on the shelf if this is the case.

 

Steelrolled

(2,022 posts)
19. I am waiting for the full list of centers for the Moderna vaccine trials
Tue Jun 30, 2020, 11:36 PM
Jun 2020

There are to be 90, but I only know of one site that was announced/leaked. If there is a site near me, I'll volunteer.

uponit7771

(90,296 posts)
24. Be careful, the last 3 plague vaccines either paralyzed people (link) or were useless and caused ...
Wed Jul 1, 2020, 12:33 AM
Jul 2020

... more death due to false sense of security.

Polio, 76 swine flu, 1918 Kansas Flu ... all bust

9 women can't make a baby in one month so non time tested vaccines aren't safe

 

Steelrolled

(2,022 posts)
30. Everyone has to make their own decisions
Wed Jul 1, 2020, 09:06 AM
Jul 2020

of risks in life. As a civilization we can't move forward without it.

Voltaire2

(12,848 posts)
6. The placebo effect is not nothing.
Tue Jun 30, 2020, 09:55 PM
Jun 2020

It is generally quite significant.

I know this seems counterintuitive but look it up.

 

Steelrolled

(2,022 posts)
20. I think it is more significant in trials for drugs
Tue Jun 30, 2020, 11:44 PM
Jun 2020

to improve your quality of life where they are dependent upon surveys for the effectiveness (e.g. rate your joint pain 1-10). In the case of COVID-19, it is more black and white, even though participants might be more inclined to ignore a mild case of COVID-19 "knowing" they have the vaccine.

One thing I wondered about, a common side effect of the vaccine is some soreness around the injection site. I would think that would not occur with the placebo, and thus some people will almost know they have the real thing.

DrToast

(6,414 posts)
29. The placebo group often receives another vaccine
Wed Jul 1, 2020, 09:02 AM
Jul 2020

Something that will mimic the physical effects (sore arm), but not the vaccine they’re testing.

Voltaire2

(12,848 posts)
27. Placebo is not non-vaccinated.
Wed Jul 1, 2020, 05:12 AM
Jul 2020

The placebo group gets vaccinated with, for example a saline solution.

The placebo group does not know that they did not get a real vaccine.

Voltaire2

(12,848 posts)
31. Except that a significant response will be detected from the placebo group
Wed Jul 1, 2020, 09:17 AM
Jul 2020

compared to a no treatment control group. There is a well documented difference. Efficacy has to be better than placebo to demonstrate real value.

Ms. Toad

(33,970 posts)
9. Halfway there.
Tue Jun 30, 2020, 10:05 PM
Jun 2020

I'll take one that is 50% more effective than a placebo in preventing COVID 19, but not one that is 50% more effective in reducing symptoms. The symptoms vary too much for me to accept that as a reason to belive the vaccine is effective.

herding cats

(19,557 posts)
11. The chatter of symptom reduction vaccines was worrisome.
Tue Jun 30, 2020, 10:10 PM
Jun 2020

An actual vaccine which is 50% more effective than a placebo is something I'd endorse.

Ms. Toad

(33,970 posts)
12. For something that has pretty standard symptoms,
Tue Jun 30, 2020, 10:15 PM
Jun 2020

I'd accept a reduciton in symptoms.

But the range of symptoms is far too broad for this disease. 50% reduction of symptoms for what might have been completely asymptomatic? nope.

herding cats

(19,557 posts)
13. All true about the far too varied symptoms and asymptote cases.
Tue Jun 30, 2020, 10:20 PM
Jun 2020

When I saw those being brandied about I was a hard no. They're, to my eyes, basically snake oil.

Ms. Toad

(33,970 posts)
22. There are so many variations,
Wed Jul 1, 2020, 12:00 AM
Jul 2020

I'm not sure it would. This disease has changed significantly. The east coast version has symptoms significantly different than the west coast, than Italy, than China. It would be hard to control for the particular mix of symptoms - since the goal isn't to treat existing symptoms. It is to prevent acquiring the disease in the first place.

So unlike treatment placebos, you can't pre-presort exposure to equivalentl groups to ensure the mixes are equivalent.

Ms. Toad

(33,970 posts)
40. This disease is unlike any other science has encountered before,
Wed Jul 1, 2020, 12:38 PM
Jul 2020

in terms of the range of symptoms, and the variation in severity. That has been my impression - and it was confirmed by Dr. Fauci. So I'm just not confident enough to risk my health on the premise that the normal statistics apply, since it is more like 50 disease, rather than a single disease.

While there are differences in disease spread among the variations, that seems less volatile than the symptoms.

DrToast

(6,414 posts)
14. It's not hard to discern it
Tue Jun 30, 2020, 10:24 PM
Jun 2020

You’ve got a vaccine group and a control group.

If the vaccine group has significantly less hospitalizations than the control group, then you know the vaccine works.

The vaccine we end up with may not prevent infection. That doesn’t mean there can’t be a useful vaccine.

Ms. Toad

(33,970 posts)
15. If you are happy with that standard, have at it.
Tue Jun 30, 2020, 10:30 PM
Jun 2020

I've just stated what my standards are, and for this particular disease I'm willling to take a vaccine with a 50% reduction in disease incidence, but not with a 50% reduction in symptoms (expecially since even mild or asymptomatic symptoms can cause permanent disease). For most diseases a 50% reduction in disease incidence is not high enough for me, but this is an extraordinarily deadly/disabling disease.

Ms. Toad

(33,970 posts)
18. No, but the risk of a new vaccine - potentially created to employ different strategies
Tue Jun 30, 2020, 11:03 PM
Jun 2020

for creating immunity than current vaccines is unknown. I need it to be more than reduces symptoms from perhaps nothing by 50% to make it worth risking the long-term consequences we will likely be unable to predict at the time we need to make the decision to take it or not.

You are free to make a different decision.

uponit7771

(90,296 posts)
25. +1, the uselessness of the 1918 Kansas flu "vaccine" is part of the cause of the uptick or
Wed Jul 1, 2020, 12:36 AM
Jul 2020

... the "second wave" that acurred at the time.

 

Steelrolled

(2,022 posts)
33. Medicine has advanced a little since 1918.
Wed Jul 1, 2020, 09:25 AM
Jul 2020

Sort of like air travel safety and a thousand other things. And those advances are based both on understanding fundamentals, and learning from mistakes. I'll participate in the Moderna trial if I can.

uponit7771

(90,296 posts)
35. We still don't have a vaccine for aides or the cold but we have a vaccine for corona virus all of
Wed Jul 1, 2020, 09:57 AM
Jul 2020

... sudden?

nah, I'll wait ... long time no way I feel safe after the last 3 - 4 horrid tails of quick vaccines during election years.

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