Do we get to see the data that was released to the FDA about the vaccines? thx in advance

[uponit7771]

Do we get to see the data that was released to the FDA about the vaccines? thx in advance

EDIT: Why? Trust and verify and transparency aides in trust process

[beachbumbob]

1. you mean "trust us" isn;t good enough?

[uponit7771]

4. +1, especially when vaccine.gov says 3 to 5 yrs for safe vaccine.

[Klaralven]

2. Not all, because some of it is private patient information

For example, specific medical notes about Covid cases.

[uponit7771]

7. Correct, are we able to see breakdowns etc that aren't related to specific patient data

[NurseJackie]

3. Why would it be necessary?

[uponit7771]

5. Trust but verify. EDIT: Trust AND verify

[NurseJackie]

31. The Cold War era Russian proverb "trust but verify" is a clear indication of hostility and distrust...

The Cold War era Russian proverb "trust but verify" is a clear indication of hostility and distrust. Why would that be necessary? What specific reason do you have for not trusting them?

[uponit7771]

34. Maybe but there are plenty in this countries mistrust is well founded.

[NurseJackie]

35. Huh?

34. Didn't post Trust But Verify

Actually you did.

[uponit7771]

36. Edited post, I thought it was to someone down thread

[NurseJackie]

61. Trust *but" verify ... trust *and* verify

It's a distinction without a difference. They both mean the same thing.

When the discussion starts to devolve to this type of meaningless hair-splitting (and post editing) it amounts to little more than distractions and are a clear indication that someone (not me) is arguing from a position of weakness.

What it boils down to is that this thread is a promoting anti-vax sentiment and is trying to engage in fear-mongering in order to create irrational distrust, and justify not getting a Covid vaccine. That's dangerous and irresponsible.

[uponit7771]

62. Reasonable transparency is the right thing to do

[NurseJackie]

63. Irrational suspicion and fear mongering and encouraging anti-vax talking points...

... is NOT the right thing to do. It's irresponsible.

[uponit7771]

65. Correct, only 14% of blacks trusting this vaccine is not irrational suspicion though and its well

... founded and grounded in facts.

A black person asking if we get to see the data from a virus study the FDA sees and getting swarmed makes me think there's two different worlds in outlook of HC in the US.

[NurseJackie]

69. Ridiculous.

Correct, only 14% of blacks trusting this vaccine is not irrational suspicion

Yes it is. You're arguing that because 86% distrust the vaccine, then they "win" the debate... and they're automatically right... simply because 86 is greater than 14? It doesn't mean they're stupid... it simply means they're wrong.

You're arguing that because 86% don't trust the vaccine, then the vaccine is suspicious and should be avoided. What it really means is 86% are wrong. These are dangerous anti-vax talking points. Trying to justify NOT taking the vaccine is irresponsible and dangerous.

[uponit7771]

70. "Yes it is." This is a overtly privileged position to take at minimum and dismissive of racism in US

... medicine in recent history when it comes to people of color.

You're arguing that because 86% don't trust the vaccine, then the vaccine is suspicious and should be avoided

This is false on its face, I've posted no such ... whatever, I got my question answered.

[hlthe2b]

6. No. The FDA WILL and the ACIP (advisory committee for CDC) can demand it

The best we can hope for is an expedited peer-reviewed journal article. FDA will do its job, but in truth there are a lot of subgroups for which we won't know how these vaccines will perform for some time (and that includes children, those with autoimmune disease, pregnant women, and others). That said, raw data is not something the general public SHOULD have available, but only those with the REAL expertise to evaluate it. Sorry, this is not a slam, but we've all seen how facts, data, testimony, can be misunderstood, manipulated, and create outrageous false conspiracy theories. We've trusted in our systems to approve and ensure safety for many many decades. We have to do so now.

Still, I DO believe FDA has NOT been compromised and I do trust those who make recommendations to CDC on the blue-ribbon panel, the ACIP (Advisory Committee on Immunization Practices). That said, we are likely to have unanswered questions on these vaccines (especially longevity and durability of the immune response) for some time to come.

[uponit7771]

8. That's too bad, seems like transparency will help with trust and verification

[hlthe2b]

10. Actually no. I edited my previous post to indicate why this is not appropriate.

and, yes, I say this as someone with experience in this area.

[uponit7771]

13. Isn't that a similar excuse Trump used to not tell us about the virus at first?

Transparency should be a priority more than concern of reaction, the more we know the better

[hlthe2b]

18. Then you are apparently not able/willing to trust in our career professionals, who have held firm

That's on you. I know those who have suffered severe career repercussions for refusing to bend to WH pressure. They did so to ENSURE only good policy drives vaccine development and delivery.

You will have the ability to read reports and reporting from those groups that examine the data and the reasoning behind their decisions. You will also likely have free access to the prestigious medical journal articles published on these vaccines since NEJM, JAVMA, the Lancet, BMJ and others have made COVID-related publications available in many cases to non-subscribers. Perhaps if you start reading the reams of articles ALREADY available on issues related to these vaccines and methods of development, you might be able to reassure yourself and to formulate the specific questions you wish your physician to help you answer.

[uponit7771]

19. Again we can trust and verify. why the pushback on the minimum of transparency?

[hlthe2b]

23. Show me one vaccine, one medication, one treatment for which you've obtained RAW data

on their Stage I, II, III clinical trials and how, exactly YOUR ability and training allowed you to interpret it in a way that professional vaccinologists, statisticians, immunologists, and other public health professionals could not. Please. I'm waiting.

I actually do have background in vaccine development and testing, though not on these particular vaccines, but enough to know what you are asking for would be the equivalent of giving you reams and reams of reams of data that you'd have no way of interpreting. You CAN, however, educate yourself on the methods, procedures of testing and the rigorous methodology that FDA and ACIP use to license and make recommendations on their use. It is all out there.

[uponit7771]

29. Strawman noted, not asking for raw data you in injected that. People, why the pushback on the data?

[hlthe2b]

30. that is EXACTLY what you are demanding.

[uponit7771]

38. Don't have "raw" in my OP and if I did so what? This is crazy, ask for data get swarmed must have

... touched a nerve

[hlthe2b]

39. You are asking for that ACTUAL data-- THAT IS RAW data.

Summary data will appear in peer-reviewed journals and FDA will review the raw data to ensure it meshes with those summaries. I'm sorry but your lack of knowledge continues on display. I do sympathize and empathize with your concerns, but you seem to be saying you don't trust the BIDEN administration aided by CAREER CDC, NIH, and FDA professionals to review and make determinations, which they are already in the process of doing

So, if you don't trust Biden et al, any of our procedures, mechanisms, and decades-long process, then, yes, I think you will either need to stay isolated the next 18-24 months, or risk natural infection and its significant complications.

[uponit7771]

42. Again, so what !? Seems like fly crap in pepper whether data is released in whole or in part the ...

... question was do we get to see the data the FDA gets?

Some of it seems like the answer

[hlthe2b]

47. Can you stop posting and then denying what you posted? I see you did with your "trust but verify"

comment upstream as well. Maybe take a break as I think your emotional state is making it tough to articulate your concerns.

[uponit7771]

58. Nah, seems like a rabbit hole position ... raw vs any. Who cares?! Doesn't

... answer the question.

I got my answer

[MineralMan]

9. Maybe, but would you be able to interpret that data yourself?

For most people the answer would be no. Statistical analysis is difficult.

I'll be good with the summarized information that is publicly released. So far, my plan is to get vaccinated just as soon as I can. At age 75, I'm hoping that's early next year.

I have no hesitation in saying that. The vaccines were developed by reliable pharmaceutical companies, who did not bow to Trump's demands to submit them early for approval. He wanted vaccines before the election. He did not get them. The companies were not ready to apply for approval by then.

[uponit7771]

11. Some of it and I know multiple people who can understand the rest

[MineralMan]

14. OK, whatever.

Why would you suspect shenanigans in the interpretation of the testing? That makes no sense. There are three active vaccines that are completing trials. There are others also in trials. It's a competitive business. I can't imagine any of them faking the results from the trials. That would be a losing proposition from the start.

[uponit7771]

17. You're kidding me right? 14% all blacks dont trust the vaccine because we're all stupid?

Your position sounds privileged at least

Also no one brought up shenanigans but you.

we can trust and verify the data there's nothing wrong with that

This is a very strong reaction to a simple question for the minimum of transparency

[MineralMan]

24. The results of the trials will be published in peer-reviewed journals.

So, they will be available, if you care to read them. They may also be made available for anyone to read, given the broad interest in them. When pdf files containing those results are available, which they are not at this time, I'm sure links will be posted here.

As for current public acceptance of the vaccines, I can't comment on that. I can only say that I will be standing in line at the first possible opportunity. Getting the vaccine seems far more appealing than getting the disease, it seems to me.

My Occam's Razor question is: Why would the companies developing this vaccine lie about its safety and efficacy?

[marble falls]

28. Uponit has a valid point, MM. It's not antivax, it's a reaction that PoC have been led to from ...

... purposefully smallpox infected trade blankets to Tuskegee Syphilis "studies" to the multimillion dollar industry that came from Henrietta Lacks cancer cells.

https://www.washingtonpost.com/opinions/2020/11/24/health-care-system-has-failed-black-americans-no-wonder-many-are-hesitant-about-vaccine/

Opinions
The health-care system has failed Black Americans. No wonder many are hesitant about a vaccine.

[MineralMan]

33. I reject the anti-vaxxer propaganda altogether.

It's bogus conspiracy theory nonsense.

I encourage others to do the same. These vaccines can save countless lives. People can get vaccinated or not. I will get vaccinated, as always, against diseases that could kill me. Others can make their own decisions.

I am not in any position to influence other people on this issue. I can only say what my decision will be. When it comes to medical issues, I listen to medical experts, not random conspiracy theorists.

[uponit7771]

41. Blacks aren't AV we're mostly distrustful of racist authoritarian admins who openly are hostile to..

... non whites.

Transparency helps in mitigating this mistrust, I'm shocked at the feed back on getting with such a simple request.

[MineralMan]

44. The data will be available. Watch for it.

Right now, it's not available. By the time the vaccines are available for widespread, the data will be available for you to examine. So, keep an eye out for it.

[uponit7771]

40. +1, the polling right now is 14% of all blacks strongly don't trust this vaccine. Look at the swarm

... I'm getting on this thread from asking about data.

There's no doubt a disconnect in America when it comes to HC

[marble falls]

48. All things considered had a very good report on this yesterday or the day before ...

I did find this:

https://www.pbs.org/newshour/nation/amid-coronavirus-pandemic-black-mistrust-of-medicine-looms

https://video.wttw.com/video/survey-32-black-adults-would-get-covid-19-vaccine-ltws3w/

https://news.wfsu.org/all-npr-news/2020-11-26/coalition-urges-black-communities-to-embrace-a-covid-19-vaccine

[hlthe2b]

46. There has been an issue with insufficient AA and other minorities inclusion in some PHASE I-III

clinical trials and it is a problem that I agree must be addressed. I believe some vaccine developing companies did a better job than others, but I agree that this must be addressed so that members of these at-risk communities feel comfortable receiving the vaccine. That these individuals were either not sufficiently recruited or did not volunteer in sufficient numbers will be addressed as HCWs and other high-risk groups receive the vaccine and that should quell some of the concern.

Given that many POC are at severe risk of complications, I do hope they will receive the vaccine. But, as with some other groups not yet fully or adequately studied (pregnant women, children, persons with autoimmune disease) and as with all vaccines, more information will be forthcoming. That said, it is clear why messaging is going to be so important and coming from persons credible within each community.

[marble falls]

52. I haven't fought cancer for the last eight years to die of Covid or faunch at using the vaccine ...

... however, we are in extraordinary times and if we didn't look seriously at the different vaccines that are being developed and released in months when vaccines generally take from three to fives years, we'd be short-sighted.

There is a risk. But we are in extraordinary times when solutions need also to be extraordinary and that figures into my calculations. I will be taking it. It's part of my white privilege to have that freedom to make that decision without all the history PoC have to look back on.

I encourage them to be vaccinated but I do understand how they need to weigh a whole lot more into their decision about it.

[hlthe2b]

53. Actually, the elderly with chronic health complications AND cancer were studied in large numbers

especially in the Pfizer and Moderna trials. But, with cancer, a consult with your oncologist will be necessary first, especially if you are actively receiving chemotherapy or immune-supressing medications.

[marble falls]

56. I use VA. I get exceptional treatment. Even some 'odd' ones, but VA has been the best thing ...

... it's a great model for a single payer system.

[beachbumbob]

12. eye brow raising issue is we hear now that we have to learn to deal with the vaccine side effects

also, what vaccines require 2 shots and spaced over time vs one and done? I tell you I ran into a huge issuewith the Shigrax shingles vaccine which is a 2 shot vaccine as the supplies were inadequate and I could not get my 2nd shot with in the specified time period without leaving the area and going out of network for the cost

[uponit7771]

15. +1, I've heard the side effects are not nice at all

[hlthe2b]

16. As one dealing directly with patient DISEASE side effects and death on near daily basis, this is not

the issue I would suggest you have uppermost in your mind.

[uponit7771]

20. NPI vs vaccine for some is a choice for others it's an imperative

... some people can't afford to have two days three days sick out of the job versus wearing a mask and staying away from other humans

[NurseJackie]

22. I imagine that being on a respirator would be a terrible inconvenience for them as well.

[uponit7771]

25. The minimum CDC recommendations have kept many people off of respirators.

[NurseJackie]

27. Clearly the "minimum" isn't good enough, is it?

[uponit7771]

32. Yes they are, when they're followed. Hundreds of other countries that have done the minimum have ...

... controlled CV19 the countries with no sentinel programs or crazy stupid racist leaders have not.

Are we now arguing that following CDC recommended NPI's don't work ?!

Seems like this simple question is going sideways quick

[NurseJackie]

43. Ridiculous. Nobody said that.

Are we now arguing that following CDC recommended NPI's don't work ?!

Ridiculous. Nobody said that.

The number speak for themselves, don't they?

Hundreds of other countries that have done the minimum have ... controlled CV19 the countries with no sentinel programs or crazy stupid racist leaders have not.

No, that's not correct. I know that New Zealand had had great success, but NOT by having "done the minimum". The went above and beyond with very strict controls and shutdowns and quarantines and travel restrictions.

That's one example I know about. Can you please list just a few of the "hundreds of other countries" that have "done the minimum" and subsequently "controlled CV19"? I'm interested in knowing more.

Seems like this simple question is going sideways quick

Oh, it wasn't a "simple question" ... it was a loaded question that's borderline anti-vax in the way it's trying to question the wisdom of getting the vaccine; or promote "masks and distancing" as a suitable alternative; or justify why people shouldn't get the vaccine; or create distrust based on reasons of race.

Seriously... what good purpose does any of this serve?

All I'm trying to say (and I'm being honest with you) is that this really isn't helping anything. The whole premise of this OP wasn't well-considered. Either it was a true lapse in judgement, or there's something else going on.

[uponit7771]

45. "clearly minimum isn't good enough" isn't an intimation that minimum CDC NPI not "good enough"!?

Cone on people I'm not OPing to argue a position its a freakin question.

This thread has been swarmed with some stupid shit, I can see the privilege dripping off some folk who inherently trust this admin, its organizations and the HC systems in America.

[NurseJackie]

49. You didn't answer my question...

You said:

Hundreds of other countries that have done the minimum have ... controlled CV19 the countries with no sentinel programs or crazy stupid racist leaders have not.

I responded:
No, that's not correct. I know that New Zealand had had great success, but NOT by having "done the minimum". They went above and beyond with very strict controls and shutdowns and quarantines and travel restrictions.

That's one example I know about. Can you please list just a few of the "hundreds of other countries" that have "done the minimum" and subsequently "controlled CV19"? I'm interested in knowing more.

You're making a very specific claim. Can you provide for me the names of the countries that have controlled Covid by doing the minimum.

This thread has been swarmed with some stupid shit, I can see the privilege dripping off some folk who inherently trust this admin, its organizations and the HC systems in America.

No, the pushback is quite reasonable to the arguments being made which try to justify this "anti-vax" posturing... and to the "don't trust big-pharma" paranoia.

[uponit7771]

57. That is the minimum !!!

. I know that New Zealand had had great success, but NOT by having "done the minimum". They went above and beyond with very strict controls and shutdowns and quarantines and travel restrictions

That is the minimum !!!

Fauci said US had NOT done the minimum, Trump never even federated the response

[NurseJackie]

59. Please answer my question. Which countries "did the minimum" and now have covid controlled?

Please answer my question. Which countries "did the minimum" and now have covid controlled?

You said there were "hundreds". Which ones? To the best of my knowledge, the countries that have been most successful have done much more than "the minimum".

It's perfectly reasonable to ask for examples countries that did the minimum and were able to control Covid. If there were "hundreds" as claimed, then naming a few of them shouldn't be a problem.

FYI: A quick google search tells me the following:

According to the U.N, there are 195 countries in the world today (plus two non-member countries with permanent observer states, the Holy See (The Vatican) and the State of Palestine. So, as of Nov 15, 2020, there are a grand total of 195 sovereign states in the world.

... there aren't even "hundreds" of countries on the planet. So I think the original claim was probably over-exaggerated. Can we agree on that?

[uponit7771]

64. Link to NYT table for countries have done the minimum and controlled the virus inside

https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html

The minimum is what New Zealand did in the beginning to control the virus, its incorrect to claim what NZ did "over and above."

I think the intimation in your question "the minimum is not working is it" is empirically wrong based on world wide data and what "the minimum" is defined to be.

The US gov has NOT done the minimum, Trump released high level NPIs too early and Fauci (below) said we didn't reach an adequate enough baseline.

Anthony Fauci says U.S. did not reach a low enough coronavirus baseline before reopening


https://www.bostonherald.com/2020/08/05/anthony-fauci-says-u-s-did-not-reach-a-low-enough-coronavirus-baseline-before-reopening/

I think doing the minimum on an individual level and a federated level is better than taking a vaccine that has not gone through the full testing regime that is described in Vaccine.gov

What say you?

tia

[NurseJackie]

67. I agree with Fauci. I disagree with you.

I don't buy-in to irrational fears or anti-vax conspiracy theories and fear-mongering. That's what I say.

I don't see hundreds of countries that you claimed.

[uponit7771]

71. I amended to say "plenty", you're wanting to fight I just asked a question. Thx for your input

[hlthe2b]

26. And that is YOUR decision to make if you feel so strongly .

Not sure what you mean by NPI, but certainly masks, social distancing, working from home, and avoiding contact for the next few years may well protect you if you are scrupulous in following these basic recommendations and are truly able to avoid ALL levels of exposure--impractical for most of us..

[hlthe2b]

37. I'm curious if you mistakenly believe you were only at risk for shingles, if you were in contact

with someone else with active varicella infection and thus the vaccine might have been unnecessary, if--, as with COVID-19, you'd merely stayed isolated, rather than receive the vaccine? If so, you are very mistaken.

Yet, you did take that vaccine, knowing it had some discomfort associated side-effects.

[MineralMan]

21. There are reported side effects for every vaccine.

Most people don't experience those side effects. The reported side effects of the current Covid vaccines are relatively mild in nature, and last only a short time. Most people don't have even those effects.

As for two-shot vaccines, yes, there are a number of them, as anyone who has young children can verify. The reason for that is that the first shot does not stimulate an adequate immune system response to create a strong immunity. The second shot, often called a "booster shot" stimulates a stronger response and establishes a longer-lasting immunity.

As for the supply issue with the second, timed vaccination, you should discuss that with the provider who will give you the vaccination. Systems will be in place to ensure reliable availability for the second injection, no doubt, whoever your provider might be.

We'll be learning more about these things as the program becomes established.

[BlueIdaho]

50. What do you call a vaccine with zero side effects?

A placebo.

[MineralMan]

51. Oddly enough, there can be side effects even with placebos.

In a controlled vaccine trial, subjects don't know whether they receive the vaccine or a placebo. Some recipients of placebos report "side effects." Those are compared with the side effects of the vaccine recipients, and the numbers of both are reported.

[BlueIdaho]

54. The famous "Placebo Effect"

The brain is amazing...

[MineralMan]

55. Yes. It's definitely real.

[Orangepeel]

60. I want experts to review it

every yahoo with an Internet connection who thinks they are an expert... not so much

[uponit7771]

66. After experts reviews it reasonable transparency on the data is the right thing to do

[MineralMan]

68. And that is exactly what will happen.

Once the FDA's scrutiny is finished, we'll see publication of data and the analyses of data.

You want something now that will be released soon, and long before the average person will even have access to the vaccine.

Healthcare workers, first responders, and people in elder care facilities will get it first. Then other vulnerable groups. Then, finally, it will be available to everyone - sometime next year.

In the meantime, data and analyses of that data will appear and you'll be able to examine it if you wish to do so.

At this moment, that data is not generally available, however.

[uponit7771]

72. "You want something now that will be released soon" This is false on its face, sup with the ...

... hostility MM?!

Damn, its a question and person gets swarmed ... this is fucked up.

I don't know what nerve I touched outside the Anti Vax but I don't see how hostility to reasonable transparency helps ... ***RATIONAL***... skepticism

https://www.reliasmedia.com/blogs/1-hospital-report/post/147266-new-survey-reveals-covid-19-vaccine-hesitancy-in-black-latino-communities

“Transparency seems key to trust-building. When Black Americans have greater information about how the vaccine works and how it was developed, they have greater willingness to take the vaccine,” the survey authors noted. “Therefore effective messaging should be open, honest, and comprehensive.”

[MineralMan]

73. Your OP was based on the assumption that the data would not

be made available. It will, but it's not yet time for that.

Here's my prediction: Once it is made available, you will not examine that data.

There's still not a long-term plan for distribution of the vaccines yet. There will be one, though, and we'll all get to see it when it's ready. Until then, we can either speculate about how "unfair" it will be, or we can wait to see what it actually is.

The peer-reviewed papers on the various vaccines will appear first in professional journals, all of which will charge to to read it. Soon after that, though, science writers will summarize that data for public consumption.

Those summaries will be available to everyone. I recommend them as your source, frankly.

Disclaimer: Since I write about neuroscience research, I pay for access to journal sites, so I can read articles as they appear without paying for individual articles. It's not cheap, but I no longer have a University library connection that gives me free access. Will I go look at the first journal articles about these vaccines? I will not. I will wait for someone who specializes in summarizing such articles to write summaries. I could read the original journal articles, but that's a time-consuming thing.

There's no secrecy involved. There will be transparency, once the official data is put into publishable form. It's not yet in that form. Submissions have been made in the requests for emergency approval by the FDA, but those are specialized submissions. You will have access to much more than that before you have to decide whether to receive the vaccine or not. There's no secret plan to keep you from getting whatever information you think is sufficient.

You're just unhappy you don't have access to it now. Patience is a virtue. The processes that normally apply will all be followed. But, here's the kicker: What is released soon will only be the results of the Stage 3 trials, most of which were limited to about 30,000 subjects in a controlled trial.

The real trial will be measured by the data generated by a large-scale release of the vaccine. In some ways, we'll all be subjects of that trial, if we take the vaccine. Those who don't will be the control group. Your choice.

[uponit7771]

76. "Your OP was based on the assumption that the data would not be made available" No it wasn't, I ...

... asked a question that was it.

I also got some more info on the AV approach, it must be a mostly white thing ... I think that's were I stepped on a land mine.

Blacks aren't AV we're just skeptical of racist bastards who are openly hostile to us like Trump and RayGun and a good portion of the kGOP.

[MineralMan]

75. Here's a just-released article in The New Scientist

That's a UK publication that is highly respected. You might want to have a read of it:

https://www.newscientist.com/article/2261805-everything-you-need-to-know-about-the-pfizer-biontech-covid-19-vaccine/

[uponit7771]

77. THX !!!