Player Availability

You'll need to clarify what you meant, because what you said makes no sense.
You are making it sound like blind faith or rubber stamping.

You don't get FDA approval unless data/findings/reports for at least six months of safety studies is turned over and thoroughly reviewed by experts who aren't part of the company.

In short, FDA approval means that at least six months of sufficient data has been rigorously examined by the public health agency to determine a vaccine's safety and efficacy. From a bureaucratic standpoint, "full" approval of any vaccine was impossible to meet earlier because of time requirements and available data.

"What took time, is that we actually go and we monitor a percentage of the sites where the clinical trials were conducted in order to make sure that the data that was collected with accuracy, and matches what was submitted to the agency."

 

Don't take my word for it. Here's the approval letter from the FDA.

August 23, 2021 Approval Letter - Comirnaty (fda.gov)

Pfizer has years to conduct studies of the effects of their vaccine and then report back to the FDA. That is in the letter. Not my words.
The FDA accepts that there hasn't been enough time or data for them to not place a warning on "Comirnaty" about the risk of heart inflammation (myocarditis and/or pericarditis). Again, not my words. Below is a direct quote from the approval letter.

"We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis"

That is what I was referring to. That is not up for debate, unless you want to debate the FDA's approval letter.

Does that mean it's a bad vaccine or that people shouldn't get vaccinated or that the sun really isn't as hot as we're told? No. It means that I don't believe this FDA approval means anything at this time. The FDA doesn't know enough, the CDC doesn't know enough, the American people, vaxxed or unvaxxed, don't know enough. FDA approves Pfizer. Great. Nothing has changed.

 

Thank you for the link.

Page 4
"You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports at monthly intervals as described in 21 CFR 600.81."

Monthly reports is not the same as what you claimed earlier ("not required to provide any data/findings/reports to the fda until 2025").

Similarly, the myocarditis studies (which you put special emphasis on) requires multiple interim reports, between now and 2025 (pages 6, 7, 8). If there are observations of potential problems, it will be reported before the final study is submitted.

You may feel that approval means nothing. I disagree.
Just because more work is to be done doesn't make the progress so far pointless.
It means that it has passed the 6 month milestone, in addition to the 2 month milestone needed for EULA. It means an independent group of experts had the time to thoroughly fact check what the company reported so far. That is important.

 

Condolences to you and your family Elvis!! Sorry to hear!!

 

So I thought we weren’t going down this path concerning the vaccinations? That didn’t take long.

 

What road would that be? Discussing implications and how it might impact the team? That's not off limits. It's real. It has a direct effect on the Pittsburgh Steelers. The subject was brought up about the fda approval and tied that to the team. I offered an opinion and the actual approval letter as a basis. My opinion on the approval doesn't need to be here. So for that, I'm out of line. But it didn't get contentious or vulgar. Topics directly regarding the Steelers have gotten far more out of hand.

But to your point, it's my opinion on things related to the virus and I'll try to curb that.

Fair enough?

 

I think its possible to have an informed discussion on the topic and that it is important to talk about it but it is a very fine line to walk. These type of things always start well but as opposing voices are heard people have a tendency to get more and more passionate about their views.
Several members have talked about their military service and the amount of unknown things injected into them during boot camp. I was talking to my Dad who was in the air force during Vietnam and hr said his brother was adamant about not getting the vaccine and that opinion is formed almost completely by his political views. I asked my Dad wasn't he in the guard which I was mistaken about he was in the Air Force like my dad and undoubtedly have numerous things injected into him. To further complicate matters my Uncle also has advanced stage MS and has over the last 20 years gotten experimental treatments through the VA. I mean this is a simple thing for some of us and a complicated one for others.

For all that we should be able to at least discuss how the resurgence is affecting the upcoming season.

 

What your describing hits very close to home for me as well. I served in the Air Force, and my daughter is active duty AF right now. My father-in-law is retired AF. My father was Navy. Lots and lots of stories. And a lot has changed since I was in, and even more since my dad and father-in-law were in. But one thing seems like it hasn't changed, and that's the injections. If there's a liquid that will fit in a vial, they're going to load it in an injection gun and shoot you with it. That's just part of the deal.

Here's to hoping that the entire team gets poked, none have any adverse reactions, and our schedule doesn't get buggered up like last season.

 

Didn’t Cam have COVID last year? I had him on my fantasy team and I remember him missing time. If he did have it, wouldn’t that give him natural immunity?

 

I notice that when people complain about breakthrough cases with the vaccinated, they tend to forget that there are also breakthrough cases with the previously infected.
(If you watched the Olympics, gold medalist Tom Dean had Covid twice in 2020.)

People tend to confuse "immunity" with "invulnerability".
Immunity just means that the body can recognize and react to the disease faster.
Better chance to fight off the infection before it gets a foothold, and better chance to only have mild symptoms that won't need hospitalization, but there are many diseases where immunity is not a 100% chance.

 

I wasn’t complaining about anything. Just wondering aloud if that may be the reason Cam didn’t get vaccinated. I’m no immunologist. I don’t know what constitutes a breakthrough case.

 

“Dammit, Jim, I’m a doctor, not an immunologi— What? They’re doctors, too? Well, crap.”

 

That's exactly what it is. Feels rushed in just before the news that is breaking now that natural immunity lasts much longer than vaccine-acquired immunity.

 

Yes, and natural immunity is far superior than that obtained with an experimental, unprecedented mRNA vaccine. Health officials who cared about you above the profits of Big Pharma would celebrate this and spread the news, instead they'll likely downplay it.

Take care of your immune system naturally and avoid the clot shot at all costs.

 

Note: At this point, I don't expect to change Maddog78's mind.

This post is aimed for anyone else, who is wondering how much validity there is to his statements.

The ultimate goal is to reduce hospitalizations.
(Remember the "flattening the curve" articles from 18 months ago?)
The Covid death rate people quote is when best medical care is available.
When that is not available (like when ICUs are at capacity), the death rate skyrockets.
(When Italy was slammed early on, it was on the order of 10x higher.)
Those are preventable deaths.
The reasoning behind of the vaccines is to get most or all of the "immunity benefits" without the risk of hospitalization / health damage / death from getting infected. The FDA approval compares the benefits/risks, and calculates if it is significantly better than the alternatives (like placebos or whatever treatments have already been approved).

They followed all timelines and procedures.
You may believe that it was rushed, but your feelings don't make it so.
(You may feel that all medical treatments should undergo a longer approval timeline, but that is a different argument than saying Covid is rushed compared to previous approvals.)

There are clips of Fox News (entertainment) hosts who claim, within the same minute, that the approval was both rushed and took too long.

By "news", I assume you mean the articles about the data from the Israel study
(Reporting about what people believe isn't the same as reporting about the accuracy of the study.)

That Facebook viral post is misleading, because it is comparing very different numbers out of context (reinfection rate vs. fraction of new cases).
https://www.politifact.com/factchec...ection-rates-do-not-tell-whole-story-about-pr

- The claim is ~1% reinfection rate from those previously infected.
There was a study done with data from the US.
The infection rate for those vaccinated is < 1%
https://www.kff.org/policy-watch/covid-19-vaccine-breakthrough-cases-data-from-the-states

There are uncertainties in both the Israel study and the US study.
But with an apples-to-apples comparison, there is no evidence for "far superior".

- 56% of new cases are from the previously vaccinated.
That ignores that around 2/3rds of the population was vaccinated.

Consider that 44% of the new cases were from a group half the size of the other.
That means the unvaccinated group (even with some of them being previously infected) is around 1.6x more likely to have a new Covid case than the vaccinated group.

Without knowing many previously infected people were in each group, it is difficult to draw any conclusions about previous infection vs. vaccine.
(Let's make an unrealistic assumption, to show why we'd want those numbers.
If all of the unvaccinated people were previously infected, then that would indicate that vaccines were actually far superior.)

 

They have long term testing that won't have results until 2025 and 2027. mRNA vaccines are unprecedented, obviously long term effects cannot be known for years. Short term effects aren't looking good either, with re-infection and transmission rates, not to mention the body count.

https://www.openvaers.com/covid-data

 

You might find this 8-month old article useful to read.
https://medicalxpress.com/news/2020-12-mrna-vaccine-safety.html

I'll highlight 2 parts in particular:
(point 1) mRNA vaccine technology is not entirely new

Although the COVID-19 vaccines made by Pfizer/BioNTech are the first mRNA vaccines to complete all clinical trial stages and be licensed for use, the technology has been around for a while.
Human trials of cancer vaccines using the same mRNA technology have been taking place since 2011. "If there was a real problem with the technology, we'd have seen it before now for sure," said Prof. Goldman.

(point 4) Corners were not cut in the clinical trials and approvals process

Safety issues that would affect significant numbers of vaccines mostly appear within two months, Prof. Goldman says.
However, after a vaccine is given to millions of people, very rare side effects that cannot be anticipated from clinical trials might develop, so researchers and regulators will be keeping a close eye on how the vaccine rollout goes.

Regulatory agencies reviewed the data from COVID-19 vaccine trials more quickly than usual by looking at it on a rolling basis rather than only once the trials were complete, but they did not fundamentally change their rules. "I really don't think that corners were cut in terms of safety," said Prof. Goldman. The process was faster than usual because researchers had already built an mRNA platform for cancer and other vaccines under trial. It meant this could be put into action as soon as the genomic sequence of the virus was shared.
Companies and governments also took the risk of producing large numbers of vaccines even before the the first stages of experimentation had been completed, which meant they were ready to begin large human trials as soon as the results were in. "It's a financial risk, because if you were wrong all this is lost. That's why the risk is shared between the private companies and the governments," said Prof. Goldman.


For the other parts of your post...
If you read my previous post, the infection rate for the vaccinated doesn't appear to be any worse than the re-infection rate for those previously ill with Covid ("natural immunity").

As for the "body count", that link is for reporting any infirmity after the time someone gets vaccinated.
That needs to be compared to the "body count" for the unvaccinated over the same length of time.
Those raw numbers do not tell how many of those cases are directly related to taking the vaccine.
(If there was some medical treatment that had absolutely no side effects, you'd still see a "body count" because people can get sick for other reasons. What you are doing is like taking the number of people who died after they ate breakfast, ignore other causes of death, and trying to imply causation with breakfast-eating.)

 

Same as Covid body count, which is anywhere from 30-60 days after a positive PCR test, a test when run at high Ct produces at a minimum of 90% false positives. Recommended Ct is 24, we run at 40+. We knew that a year ago, and yet continued mass testing of healthy people.

Almost like they wanted the "pandemic" to go on indefinitely.

 

That is more incorrect information, probably fueled by a Breitbart article at the beginning of the year (that was later rewritten to remove incorrect info and misleading false-positive claims).

(1) The tests have a specificity of 99.9%. It is incorrect to say there are 90% false positives
(If you are focusing on "body counts", the test is accurate to tell if someone has been infected.)
https://gidmk.medium.com/most-positive-coronavirus-tests-are-true-positives-60c95fe54fec

(2) The tests are for finding out if someone has been "infected". That is accurate, even with the 40 threshold.
The arguments about tightening the test threshold to 35 or 30 are related to "contagiousness".
That is a more confusing argument to dive into, because viral loads (what is being tested) is not directly correlated with transmission rates or severity of the illness.
https://healthfeedback.org/claimrev...nge-threshold-or-criteria-for-a-positive-test

(3) The recommendation to set the threshold at 24 was made by an Indian cardiologist, reflecting his opinion.
When eminent microbiologists are consulted, they disagree with his claims.
(Setting the threshold at 24 will miss far too many people who are contagious.)
https://www.indiatoday.in/fact-chec...covid-patients-coronavirus-1722733-2020-09-17


To get back to football, the players are being tested regularly. I'd think they'd want to use a high Ct threshold test, to catch cases as soon as possible. For them a positive test is likely early in the infection, so there is a chance to isolate them during the time window when they are the most contagious.

 

Thanks for bringing it back to player availability, MJB.

 

I was referring to a NYT article from a year ago. Ct is everything in a PCR test. Also, SARS-Cov-2 positive doesn't equate to a "Covid case", this is a big source of confusion. Like saying someone HIV positive has AIDS. Thank Fauci for that confusion in both cases. He's a turd.

The mass testing of healthy people has no doubt fueled this "pandemic" into a 2nd year, which in truth it ended over a year ago.

You've been lied to about everything - infection/hospitalizations/death rates using faulty metrics. the effectiveness of masks, asymptomatic spread, "vaccine" efficacy and safety, lockdowns effectiveness, variants, natural immunity, the effectiveness of cheap, globally used therapeutics, risks posed to children, etc.

The result has been the most massive and rapid shift in wealth from the middle to elite in world history, and the biggest authoritarian power grab in history, all for a disease with a 99.97% survival rate if you're under the age of 70.

FOH.

 

Ravens lose jk Dobbins with torn acl.

 

Who