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

[Yo_Mama_Been_Loggin]

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

[unblock]

1. horrible headline. msn editor needs to go back to math class.

[lunasun]

2. What has it been in recent annual flu shots does anyone know ? I wonder if the vaccine also

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. A few nights ago on CNN with Elizabeth Cohen, Dr. Fauci said,

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

[uponit7771]

5. Looking at the history of plague vaccines I will not be the first to take one. This is crazy, one..

... 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.

[Initech]

7. Holy crap, history really is repeating itself!

[uponit7771]

23. Yes, that "dip" was high NPI the "second wave" was a vaccine that was great at fighting bacteria fro

... 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]

19. I am waiting for the full list of centers for the Moderna vaccine trials

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]

24. Be careful, the last 3 plague vaccines either paralyzed people (link) or were useless and caused ...

... 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]

30. Everyone has to make their own decisions

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

[world wide wally]

4. What exactly is 50% more than nothing?

[Voltaire2]

6. The placebo effect is not nothing.

It is generally quite significant.

I know this seems counterintuitive but look it up.

[Initech]

8. Last I checked, zero divided by zero is still zero.

Unless I have my math wrong, which I don't.

[Ms. Toad]

10. The placebo effect is non-zero. n/t

[Steelrolled]

20. I think it is more significant in trials for drugs

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.

[Voltaire2]

26. Nope. It is pervasive.

[DrToast]

29. The placebo group often receives another vaccine

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

[DrToast]

17. You compare disease in those vaccinated to those non-vaccinated (placebo)

[Voltaire2]

27. Placebo is not non-vaccinated.

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.

[DrToast]

28. If you don't receive a vaccine, you are non-vaccinated

[Voltaire2]

31. Except that a significant response will be detected from the placebo group

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

[ecstatic]

34. That's interesting. Thanks for sharing.

The human brain is incredible when used correctly. Lol

[DrToast]

38. Why are you trying to argue points I'm not making

Are you replying to the wrong person?

[Voltaire2]

39. You appeared to be supporting the claim originally made that placebo has zero effect.

[Ms. Toad]

9. Halfway there.

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]

11. The chatter of symptom reduction vaccines was worrisome.

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

[Ms. Toad]

12. For something that has pretty standard symptoms,

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]

13. All true about the far too varied symptoms and asymptote cases.

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

[Steelrolled]

21. Wouldn't that be factored out in the statistics?

[Ms. Toad]

22. There are so many variations,

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.

[Steelrolled]

32. I'm not sure either, it would depend on the size of the

effect, but 30000 is quite a few people.

[Ms. Toad]

40. This disease is unlike any other science has encountered before,

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]

14. It's not hard to discern it

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]

15. If you are happy with that standard, have at it.

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.

[DrToast]

16. You'd rather get the full blown disease?

[Ms. Toad]

18. No, but the risk of a new vaccine - potentially created to employ different strategies

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]

25. +1, the uselessness of the 1918 Kansas flu "vaccine" is part of the cause of the uptick or

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

[Steelrolled]

33. Medicine has advanced a little since 1918.

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]

35. We still don't have a vaccine for aides or the cold but we have a vaccine for corona virus all of

... 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.

[Steelrolled]

36. Don't blame you.

[Steelrolled]

37. I found a useful source for vaccine trial information written for the general public.

https://www.cdc.gov/vaccines/hcp/conversations/ensuring-safe-vaccines.html