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What's going on with covid vaccines for kids under 5? (1 Viewer)

Will you get your under 5 year old vaccinated?


  • Total voters
    31

Doug B

Footballguy
The email address of that link is https://www.fda.gov/media/159195/download . However, there is no page https://www.fda.gov/media . Again, might be nothing, might be a strange website organization thing on the FDA's end ... but at the moment I am suspicious.
All right ... I can find many files on the FDA's site in the format https://www.fda.gov/media/[six digit number]/download . I cannot find via search this particular file, the Vaccines and Related Biological Products Advisory Committee Meeting of June 15, 2022. Been looking here to no avail.

 

Max Power

Footballguy
I need to know what that -370 precisely means.
My basic understanding: the smaller the confidence interval, the more confident people are in the data.

The CI dropped below zero in this situation due to the amount of kids who tested positive before the third dose. At that point they can no longer use them and have to factor them on the negative side of the spectrum. 

That 75% was from the remaining children who weren't excluded from a positive test earlier in the study.

 

Doug B

Footballguy
The email address of that link is https://www.fda.gov/media/159195/download . However, there is no page https://www.fda.gov/media . Again, might be nothing, might be a strange website organization thing on the FDA's end ... but at the moment I am suspicious.
All right ... I can find many files on the FDA's site in the format https://www.fda.gov/media/[six digit number]/download . I cannot find via search this particular file, the Vaccines and Related Biological Products Advisory Committee Meeting of June 15, 2022. Been looking here to no avail.
For the moment, the FDA information linked seems legit. Now off to get a read on that confidence interval stuff. Probably address that later.

 

Max Power

Footballguy
For the moment, the FDA information linked seems legit. Now off to get a read on that confidence interval stuff. Probably address that later.
The other blog I saw with the info was linked the same way, I'm not sure how to find it on the FDA website, but I remember fighting the same battle trying to find a "media" page on their site last year.

 

Terminalxylem

Footballguy
I need to know what that -370 precisely means.
Given the findings, it means there is a 95% chance true vaccine efficacy falls between -370 and 99.6%. The wide interval suggests there weren’t many data points (infections) in their studied population.

IOW, in the trial they found the vaccine was 75% effective at preventing covid more than a week after receiving a third dose. But accounting for statistical uncertainty in the data (due to low case counts - there were only 2), the vaccine recipients might actually be 3.7X more likely to be infected, to roughly 1X less likely.

So no meaningful conclusion can be drawn in that subgroup, kids aged 6-23 months. The trial is underpowered to reach a conclusion one way or the other.

 

Terminalxylem

Footballguy
So a negative confidence interval means 'statistically no more effective than placebo'?
No different than the comparator, which I believe was a placebo in this study (I haven’t read the methods, could be shot vs. no shot, which isn’t exactly placebo).

 

Max Power

Footballguy
WSJ ran a piece asking what is going on here...

Why the Rush for Toddler Vaccines? - WSJ

Covid was clearly a health emergency for adults in 2020. By contrast, the urgency now feels political.

‘This is a very historic milestone, a monumental step forward,” President Biden declared last week after the Food and Drug Administration authorized Pfizer and Moderna vaccines for toddlers. “The United States is now the first country in the world to offer safe and effective Covid-19 vaccines for children as young as 6 months old.”

In fact, we don’t know if the vaccines are safe and effective. The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency. The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation.

...

The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick. But the FDA conspicuously lowered its standards to approve Covid vaccines for toddlers.

...

More troubling, vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo. Pfizer claimed most severe cases weren’t “clinically significant,” whatever that means, but this was all the more reason that the FDA should have required a longer follow-up before authorizing the vaccine.

Also worrisome: Most kids who developed multiple infections during the trial were vaccinated. This warranted more investigation, since experimental vaccines for other diseases sometimes increase susceptibility to infection.

 

LawFitz

Footballguy
Dare I ask how "open vaers" is different from the actual vaers system?


Open VAERS is a data aggregator and presenter of the VAERS raw stats in a more elegant format, which is much easier to use, especially for the novice public. The actual VAERS system is terribly clunky and esoteric, making access to and analysis of the raw data exceedingly difficult for even seasoned users of their site. Open VAERS does the work for you.

 

The Commish

Footballguy
Open VAERS is a data aggregator and presenter of the VAERS raw stats in a more elegant format, which is much easier to use, especially for the novice public. The actual VAERS system is terribly clunky and esoteric, making access to and analysis of the raw data exceedingly difficult for even seasoned users of their site. Open VAERS does the work for you.
Thanks....I don't have a particular problem with vaers....it's not all that complicated.  I'll just throw out there, nothing on this "open vaers" site tells you what's behind their numbers and what criteria they used to create them.  Take it all FWIW.....which seems to be another person's/group's view of what vaers is.  I still recommend going to vaers directly if you're going to insist on going to any of this stuff at all.  

 

LawFitz

Footballguy
nothing on this "open vaers" site tells you what's behind their numbers and what criteria they used to create them. 


https://openvaers.com/faq

Is your Data exactly the same as HHS? Do you edit?

We do not change, modify or vet data. We take the downloads, upload them to our server and put a different face on them so they are easier to browse and get quick accurate info from. There are mistakes in the data (impossible dates are usually the most obvious), clearly, but we leave it as we get it.

 
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The Commish

Footballguy
nothing on this "open vaers" site tells you what's behind their numbers and what criteria they used to create them. 


https://openvaers.com/faq

Is your Data exactly the same as HHS? Do you edit?

We do not change, modify or vet data. We take the downloads, upload them to our server and put a different face on them so they are easier to browse and get quick accurate info from. There are mistakes in the data (impossible dates are usually the most obvious), clearly, but we leave it as we get it.
They are telling you what I just told you :shrug:  

But thanks for validating...that comment you quoted is exactly why I wrote what I did after reading the FAQ myself.

 

Dickies

Footballguy
Open VAERS is a data aggregator and presenter of the VAERS raw stats in a more elegant format, which is much easier to use, especially for the novice public. The actual VAERS system is terribly clunky and esoteric, making access to and analysis of the raw data exceedingly difficult for even seasoned users of their site. Open VAERS does the work for you.
The data really isn't there to be analyzed.  The point is merely to be an early warning system so that any trends regarding safety concerns can be referred for analysis in a controlled manner.

From the VAERS website.

VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Reports to VAERS can also be biased. As a result, there are limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can often quickly detect an early hint or warning of a safety problem with a vaccine. VAERS is one component of CDC's and FDA's multifaceted approach to monitoring safety after vaccines are licensed or authorized for use. There are multiple, complementary systems that CDC and FDA use to capture and validate data from different sources. VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as “safety signals.” If a possible safety signal is found in VAERS, further analysis is performed with other safety systems, such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA) Project, or in the FDA BEST (Biologics Effectiveness and Safety) system. These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events

 

LawFitz

Footballguy
The data really isn't there to be analyzed.  The point is merely to be an early warning system so that any trends regarding safety concerns can be referred for analysis in a controlled manner.

From the VAERS website.


Oh there's data to be analyzed. Ignore it all you want. Plenty of us aren't going to do that no matter how many times you demand we do with your gas lighting. And I'll keep posting that data on this board and everywhere else for those who are interested. You've said your piece in retort. The people can decide whether or not to pay attention to this information.

 

LawFitz

Footballguy
They are telling you what I just told you :shrug:  

But thanks for validating...that comment you quoted is exactly why I wrote what I did after reading the FAQ myself.


I believe you are misconstruing what you bolded.

Is your Data exactly the same as HHS? Do you edit?

We do not change, modify or vet data. We take the downloads, upload them to our server and put a different face on them so they are easier to browse and get quick accurate info from. There are mistakes in the data (impossible dates are usually the most obvious), clearly, but we leave it as we get it.


I take the bolded to mean that they are cleaning up the presentation of the data to be more easily readable/digestible. As evidence of that, look no further than that underlined last part.

 

The Commish

Footballguy
Oh there's data to be analyzed. Ignore it all you want. Plenty of us aren't going to do that no matter how many times you demand we do with your gas lighting. And I'll keep posting that data on this board and everywhere else for those who are interested. You've said your piece in retort. The people can decide whether or not to pay attention to this information.
You should...certainly your right.  All I've done is point out what it is and why it can be problematic....the SOURCE is always the best place to go, not second, third, fourth, fifth hand.  You go boy!!!!

 

The Commish

Footballguy
I believe you are misconstruing what you bolded.

I take the bolded to mean that they are cleaning up the presentation of the data to be more easily readable/digestible. As evidence of that, look no further than that underlined last part.
na....until they show their formulas and their thought process, it's exactly as I stated.  All you're doing by going to this site instead of the source is allowing another factor of bias/interpretation to get between you and the actual data.  They just happen to be framing it in a way that's palatable to you....I'll stick with the source data and what it's there for as stated by those who built and maintain it.

 

LawFitz

Footballguy
You should...certainly your right.  All I've done is point out what it is and why it can be problematic....the SOURCE is always the best place to go, not second, third, fourth, fifth hand.  You go boy!!!!


I vetted Open VAERS one time a while ago against VAERS and their data perfectly matched. I choose to believe them. They are much easier to use than VAERS... Same data - much better presentation. I don't disagree with your last statement, but in this case the secondary source is just fine for me, since I trust them to properly convey the source data. But you do you. Boy.

 

The Commish

Footballguy
I vetted Open VAERS one time a while ago against VAERS and their data perfectly matched. I choose to believe them. They are much easier to use than VAERS... Same data - much better presentation. I don't disagree with your last statement, but in this case the secondary source is just fine for me, since I trust them to properly convey the source data. But you do you. Boy.
No you didn't....it would take you MONTHS to do that  :lmao:  

You don't even know they queries behind their numbers.  There is NO way you can do what you claimed without a bunch of information directly from them on how they do it.  Just weeding through vaers itself to get baseline would take you months to do.

 

LawFitz

Footballguy
No you didn't....it would take you MONTHS to do that  :lmao:  

You don't even know they queries behind their numbers.  There is NO way you can do what you claimed without a bunch of information directly from them on how they do it.  Just weeding through vaers itself to get baseline would take you months to do.


I should have worded it better... I didn't vet ALL the data in that instance - but a few individual stats. Three or so, if I recall correctly. They each matched. And yes, I did run the search queries, as I had a few other times after discovering VAERS a few months before that point. They were a total PIA, which is why I stopped using VAERS after I discovered Open VAERS. (Also illuminated to me just how few of the actual adverse reactions are being reported to VAERS, given how painfully user-unfriendly that site is.)

Clearly you have a disingenuous and nefarious agenda here, though - it was clearly never about learning about Open VAERS, but rather Source Policing and attempted nullifying by whatever means you could come up with. Classic Sea Lioning and Gas Lighting, as well, in case anyone else here has ever wondered how these techniques actually look in practice.  :blackdot:

 

The Commish

Footballguy
I should have worded it better... I didn't vet ALL the data in that instance - but a few individual stats. Three or so, if I recall correctly. They each matched. And yes, I did run the search queries, as I had a few other times after discovering VAERS a few months before that point. They were a total PIA, which is why I stopped using VAERS after I discovered Open VAERS. (Also illuminated to me just how few of the actual adverse reactions are being reported to VAERS, given how painfully user-unfriendly that site is.)

Clearly you have a disingenuous and nefarious agenda here, though - it was clearly never about learning about Open VAERS, but rather Source Policing and attempted nullifying by whatever means you could come up with. Classic Sea Lioning and Gas Lighting, as well, in case anyone else here has ever wondered how these techniques actually look in practice.  :blackdot:
You don't have access to the system in the ways you'd need to in order to do what you're claiming.  You need to stop while you're behind.  I have YET to dispute the source.  I have made ZERO comments towards it's validity other than to say they are not a primary source and that we have no way of knowing what decisions they made in presenting the raw data and saying that it's a second/third hand account.  It's fine to choose to use sources like that.  Just don't pretend they are something they aren't.  That site is simply someone else's view of the vaers system...period.

 

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