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HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots

I think ivermectun had to be said not to work because then big pharma could be sued for pushing vaccines. That whole billions to pennies (ivermectun) will cause people to do unethical things
 
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obviously you do if you are asking giant eagle pharmacist for medical emergency advice.

you dont listen to internet cucks but you ask for advice in a potential medical emergency from a person who's job it is to suggest cough medicine to people grocery shopping??

weird take

Giant Eagle pharmacist??? LOL! That's the last place I'd go for any kind of medical advice. But they can give you advice on the best shampoo, possibly.
 
You'd have to be a complete moron to get another Covid shot. And you'd deserve what you'd get, harmful long-term side effects included. There is no way I'd ever get another poison Covid shot, including if the government mandated it. It's not a vaccine.
First, the government cannot mandate vaccines. Second, the Covid vaccine saved millions of lives. Had the vaccine gotten out in December 2020 as it should have and people got the vaccine in the USA, 500,000 fewer Americans would not have died. Very few people who were up to date on Covid vaccine died.
You'd have to be a complete moron to get another Covid shot. And you'd deserve what you'd get, harmful long-term side effects included. There is no way I'd ever get another poison Covid shot, including if the government mandated it. It's not a vaccine.
 
I think ivermectun had to be said not to work because then big pharma could be sued for pushing vaccines. That whole billions to pennies (ivermectun) will cause people to do unethical things
it was an emergency use authorization quirk if there were any alternative it wouldn't have been permitted. so we spent months talking about 'anecdotal data' and whatnot regarding treatment like ivermectin. and now we are justifying the annual flu shot with an efficacy topping out around 40% yearly. basically they get to cook data and will spend endless time justifying it
 
First, the government cannot mandate vaccines. Second, the Covid vaccine saved millions of lives. Had the vaccine gotten out in December 2020 as it should have and people got the vaccine in the USA, 500,000 fewer Americans would not have died. Very few people who were up to date on Covid vaccine died.
To be fair, the federal executive branch effectively tried to mandate vaccinations for a very large segment of the population via OSHA requirements, which was struck down by the Supreme Court.
 
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My daughter-in-law has the exact same symptoms. She never had Covid but had a Covid shot and booster. To this day, she has problems with smell and things taste differently or not at all. And the Covid shot didn't prevent her from getting Covid. It was just because she wasn't around people close enough who had it to get it. The Covid shots caused her to lose her ability to taste and smell things as she once did.
Sounds like long Covid. Very common after Covid disease. How do you know she did not have Covid?
 
Li
To be fair, the federal executive branch effectively tried to mandate vaccinations for a very large segment of the population via OSHA requirements, which was struck down by the Supreme Court.
ke I said, the government cannot mandate vaccines. Employers etc can do it to keep your job, but not the government.
 
Li

ke I said, the government cannot mandate vaccines. Employers etc can do it to keep your job, but not the government.
The federal government did effectively mandated it via OSHA. Until it was struck down as such, such federal mandates were in force. Just like any current executive branch order is in force today until it might be struck down by courts or reversed by law. I know I was required to upload vaccination records at the threat of losing my employment until the requirement was struck down. Suggesting otherwise by word parsing discredits other valid points you might have.
 
This review paper, which I only skimmed, is interesting collection of a whole bunch of things, all seeming to brought to support a presumed position. From my years in neurovirology research, I can tell you that attributing neurotoxicity, or other toxicities, to viral proteins is fraught with issues, primarily, whether deleterious effects are caused by levels of proteins found any near what is observed in people, or in confirmations found naturally. In high enough levels, anything is toxic. An example, billions and decades in research have chased the rabbit of gp120 toxicity down the hole of HIV associated cognitive disorders. There are still schools of thought out there, but, in my opinion and many colleagues, it was and is a giant red herring.

Not to say that is the case with everything discussed in this paper, but there are a bunch of holes in what is being discussed and seem to be completely glossed over. I'll give you an example: it spends a lot of effort building a case that nanoparticles cross the blood brain barrier resulting in transfection and expression of spike protein in the brain, resulting neurotoxcities, and that may be true, but the paper highlights brain pathology as "spike protein caused degeneration of neurovascular endothelial cells with endotheliitis, cytokine release, and neural capillary damage." In this statement, they are making a causitive claim with nothing but correlary pathology, but this pathology itself suggests damage to the blood brain barrier which could have been caused by all sorts of underlying conditions that may have existed well before any vacination, and which would allow all maner of things to cross including free viral proteins and lipid nanoparticles. More importantly, details on the cause of death of the patients these autopsaies were performed on was not discussed in any context (unless I missed it). There appear to be a ton of holes, and no smoking guns despite repeated claims, but regardless of the apparent agenda of the article, it does point out things that warrant continued study.

That uncertainty is why the medical establishment shouldn't mount a campaign to scare people into taking an unapproved vaccine/genetic based therapy and coordinate the cancelling of critical clinicians and researchers.

I realize the limitations of the scientific method. Your points are valid. The vaccine promoters and CDC & Co. didn't seem to share your balance and candor when they made claims about the disease and their mRNA treatment. I picked this study because it was published by the NIH and made the specific claims it did.

But, let's assume Spike is toxic. Would it then make sense to inject mRNA to make your cells manufacture Spike on top of the Spike from the viral infection?

The EUA trials threw up red flags for anyone who made the effort to find and review them. And the Dr. Ralph Baric video interview was out there immediately detailing the cleavage sites and the Spike protein's role in the gain of function.

Also, there are recent new pathology studies that claim causation. I'm always hesitant to jump up on them because so many studies are over hyped.
 
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Giant Eagle pharmacist??? LOL! That's the last place I'd go for any kind of medical advice. But they can give you advice on the best shampoo, possibly.






I went to report what I thought might be a reaction after the vaccine.
Did you read the Souf post about them wanting people to wait after the injection ?

I walked around Giant Eagle looking for an MD but I couldn't find one in the produce or canned goods sections,so i did the next best thing available to me . Do you think Ben Casey,Marcus Welby, and Dr Kildare have a medical practice next to the bakery in Giant Eagle but I chose to go to the pharmacy instead ?

Or would you have stood in the middle of Giant Eagle praying you didn't pass out or worse after getting the vaccine and having what you thought could be a potential reaction and fall and possibly crack your head open like an idiot ?






I went to someone actually trained on giving injections (again, as clearly stated by Souf)and recognizing the signs and symptoms of a reaction due to their specialized training pertaining to vaccine injections.

You couldn't have possibly read his posts.

And why are you concerned about who I went to anyway ? Dumb. And like most people,if we were next to each other you wouldn't say a damn thing about it. You're just trying to be cute because you have an audience here.

What's wrong with you ? I'm dealing with a 5 year battle with no taste and you want to be an ass about the situation?



Let me guess. You would have went to your car, drove 15 minutes to Med-Express while feeling you may be having a reaction to the vaccine.

Possibly getting into an accident if you were having a bad reaction....

Instead of just walking 20 feet to someone trained in knowing the signs and symptoms of a reaction and who can call an ambulance in an instant if they deem it necessary ?
Is that really what you're saying ?


Good grief.
 
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That uncertainty is why the medical establishment shouldn't mount a campaign to scare people into taking an unapproved vaccine/genetic based therapy and coordinate the cancelling of critical clinicians and researchers.

I realize the limitations of the scientific method. Your points are valid. The vaccine promoters and CDC & Co. didn't seem to share your balance and candor when they made claims about the disease and their mRNA treatment. I picked this study because it was published by the NIH and made the specific claims it did.

But, let's assume Spike is toxic. Would it then make sense to inject mRNA to make your cells manufacture Spike on top of the Spike from the viral infection?

The EUA trials threw up red flags for anyone who made the effort to find and review them. And the Dr. Ralph Baric video interview was out there immediately detailing the cleavage sites and the Spike protein's role in the gain of function.

Also, there are recent new pathology studies that claim causation. I'm always hesitant to jump up on them because so many studies are over hyped.
Just some clarifications:

1) this wasn't a study. It was a review, of sorts (probably invited because it was a special issue of the journal on the topic), of other studies, some of which weren't published or peer reviewed (such as images from abstracts or talks), along with other miscellaneous info (some very strange, like a copy of a slide of FDA's anticipated adverse reactions for which point I can only speculate). The bias in the article undermine some of its more valid concerns. It reads more like an editorial than a typical review paper. That doesn't mean its points are wrong, it just means you have to consider them in a context where the authors' seem to be motivated by a particular bias.

2) it wasn't published by NIH. It was published by the journal Biomedicines and the authors were based in Australia. What you saw (and linked) was its listing in PubMed, which is the NIH's public index of health and bioscience publications, many of which contain the open access full text. Nearly every article ever published is listed in this searchable index (>38 million publications), and every study receiving NIH funding is required to provide the full text as open access within a certain period of time from original publication.

3) There is no such thing as "EUA trials". EUAs are basically a temporary regulatory mechanism that can be employed to bypass legally required adequate-and-well-controlled trials to allow the use of unapproved investigational products during times of national strategic emergencies based solely on the reasonable possibility that something might work when there are no other approved options.

4) Any protein can be toxic if levels are too high. There are so many papers out there that essentially dump taco bell hot sauce in a plate of cultured cells and title it something like "neurodegneration of PC-12 neurons when treated with FIRE but not MILD taco bell condiments".
 
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I went to report what I thought might be a reaction after the vaccine.
Did you read the Souf post about them wanting people to wait after the injection ?

I walked around Giant Eagle looking for an MD but I couldn't find one in the produce or canned goods sections,so i did the next best thing available to me . Do you think Ben Casey,Marcus Welby, and Dr Kildare have a medical practice next to the bakery in Giant Eagle but I chose to go to the pharmacy instead ?
Or would you have stood in the middle of Giant Eagle praying you didn't pass out or worse after getting the vaccine and having what you thought could be a potential reaction ?






I went to someone actually trained on giving injections (again, as clearly stated by Souf)and recognizing the signs and symptoms of a reaction due to their specialized training pertaining to vaccine injections.

You couldn't have possibly read his posts.

And why are you concerned about who I went to anyway ? Dumb.

What's wrong with you ? I'm dealing with a 5 year battle with no taste and you want to be an ass about the situation?



Let me guess. You would have went to your car, drove 15 minutes to Med-Express while feeling you may be having a reaction to the vaccine.

Possibly getting into an accident if you were having a bad reaction....

Instead of just walking 20 feet to someone trained in knowing the signs and symptoms of a reaction and who can call an ambulance in an instant if they deem it necessary ?
Is that really what you're saying ?


Good grief.

I don't read souf posts anymore. I don't care what he says.

The best solution would have been to not get the poison shot to begin with in hindsight. But we were fear-mongered into believing we MUST get these shots so that we couldn't contract or spread the virus to others. Total lies. And the pharmacies were part of the fear mongering. They were and are part of the problem.

I know pharmacists and I know pharmacists in Giant Eagles. There is a difference. I don't trust any of them, but definitely would not go near a Giant Eagle for pharmacy needs.
 
I don't read souf posts anymore. I don't care what he says.

The best solution would have been to not get the poison shot to begin with in hindsight. But we were fear-mongered into believing we MUST get these shots so that we couldn't contract or spread the virus to others. Total lies. And the pharmacies were part of the fear mongering. They were and are part of the problem.

I know pharmacists and I know pharmacists in Giant Eagles. There is a difference. I don't trust any of them, but definitely would not go near a Giant Eagle for pharmacy needs.

Didn't you get enough attention as a child ?

Of course you don't care about Soufs posts or my condition. It's all about you. The narcissism is palpable. Your need to continuously post in almost every thread is proof of that. Im sure you thought everyone was breathlessly waiting on your opinion on Giant Eagle Pharmacists lol.

No one cares about your opinion on Soufs posts,Giant Eagle pharmacists, pharmacists in general, the vaccine,my situation, your paranoia or anything else except you and maybe any other idiots with no lives whose life revolves around the
LR.

Your grandiose sense of self-importance is hilarious.
 
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Just some clarifications:

1) this wasn't a study. It was a review, of sorts (probably invited because it was a special issue of the journal on the topic), of other studies, some of which weren't published or peer reviewed (such as images from abstracts or talks), along with other miscellaneous info (some very strange, like a copy of a slide of FDA's anticipated adverse reactions for which point I can only speculate). The bias in the article undermine some of its more valid concerns. It reads more like an editorial than a typical review paper. That doesn't mean its points are wrong, it just means you have to consider them in a context where the authors' seem to be motivated by a particular bias.

2) it wasn't published by NIH. It was published by the journal Biomedicines and the authors were based in Australia. What you saw (and linked) was its listing in PubMed, which is the NIH's public index of health and bioscience publications, many of which contain the open access full text. Nearly every article ever published is listed in this searchable index (>38 million publications), and every study receiving NIH funding is required to provide the full text as open access within a certain period of time from original publication.

3) There is no such thing as "EUA trials". EUAs are basically a temporary regulatory mechanism that can be employed to bypass legally required adequate-and-well-controlled trials to allow the use of unapproved investigational products during times of national strategic emergencies based solely on the reasonable possibility that something might work when there are no other approved options.

4) Any protein can be toxic if levels are too high. There are so many papers out there that essentially dump taco bell hot sauce in a plate of cultured cells and title it something like "neurodegneration of PC-12 neurons when treated with FIRE but not MILD taco bell condiments".
Thanks. You're right if course on 1 & 2. It was a review of studies (and other related material) Medicine is science mixed with opinion, and as you pointed out (inferred under your number 4), there's wiggle room for spin, at least to some extent, on every conclusion/interpretation of data. That's where guys like you come in to set up standards.

Your willingness to clarify is by no means unappreciated, and your attempts to make balanced comments are noticed. To your credit you're not going full apologist mode and ridiculing every concern we have.

I'd take exception to number 3. Maybe you can clarify here too.

There were trials performed by Pfizer and Moderna, etc. which were submitted in order to get authorization. I remember a researcher going through them and pointing out adverse reactions to the vaccine. He also pointed out the results showing no statistical difference between vaxxed and unvaxxed subjects, as far as mortality. These studies only went out like like 3 months or so. This was 5 years ago. I will try again to find the video and studies.

Anyhow, I find it hard to believe the FDA or whatever agency, grants EUA without any data whatsoever. I need to confirm exactly what these trials were and to whom they were submitted. Approvals can be denied. There has to be more criteria than just, "We got nowhere else to go". 😉

The fact that these trials were ignored in the media has always fueled my skepticism.
 
Besides, Covid has been over for years now. Now we have to live with the severe harmful side effects of the shots and long-term Covid that was manufactured by a Chinese lab and funded in part by Fauci. Give me a f#cking break!

Proof!

Cuckoo cuckoo cuckoo
 
Thanks. You're right if course on 1 & 2. It was a review of studies (and other related material) Medicine is science mixed with opinion, and as you pointed out (inferred under your number 4), there's wiggle room for spin, at least to some extent, on every conclusion/interpretation of data. That's where guys like you come in to set up standards.

Your willingness to clarify is by no means unappreciated, and your attempts to make balanced comments are noticed. To your credit you're not going full apologist mode and ridiculing every concern we have.

I'd take exception to number 3. Maybe you can clarify here too.

There were trials performed by Pfizer and Moderna, etc. which were submitted in order to get authorization. I remember a researcher going through them and pointing out adverse reactions to the vaccine. He also pointed out the results showing no statistical difference between vaxxed and unvaxxed subjects, as far as mortality. These studies only went out like like 3 months or so. This was 5 years ago. I will try again to find the video and studies.

Anyhow, I find it hard to believe the FDA or whatever agency, grants EUA without any data whatsoever. I need to confirm exactly what these trials were and to whom they were submitted. Approvals can be denied. There has to be more criteria than just, "We got nowhere else to go". 😉

The fact that these trials were ignored in the media has always fueled my skepticism.
Trials are never done to get a EUA. Trials are done to support eventual, normal marketing approvals. Whatever nonclinical studies or human trials had already been conducted, or were in the process of being conducted and from which interim data exists, were what was submitted with the EUA application or in support of an EUA applications. The studies weren't conducted specifically for the purposes of obtaining an EUA...defeats the purpose of the "emergency" part.

Every decision is made on a risk/benefit determination. There is always risk for any drug, even aspirin. The amount of risk that is considered acceptable, whether for a traditional approval, an EUA, or even compassionate use/expanded access during non-emergencies, is made by weighing both the known and unknown possible risks vs the potential benefits, which take into account the seriousness and probable deleterious outcomes of the disease that is being requested to treat. Obviously in a proclaimed national emergency, it is presumed that risk tolerability is quite high because the situation is perilious. But in a normal situation, for example the decision on a traditional approval of a new drug, a high risk would be much more tolerable for a terminal cancer than, say, diabetes which has 100s of treatment options as adjuncts to diet and exercise.

So the amount of data needed to grant an EUA depends on the perceived risks vs potential benefit and how much data is needed to mitigate the possible risks enough, and how much data strengthens the possibility of a possible benefit, when weighing whether to ok an EUA application and letting an unproven substance out in the public at a potentially large scale. But, in any declared emergency scenario, the very statuatory requirements of EUAs means the bar of evidence is going to be much, much lower than a traditional approval process.

All the FDA EUAs for COVID, both vaccines and nonvaccine products, and the decision letters, full reviews including lists of reviewers, and other documents are public if you want to actually look at them: https://www.fda.gov/emergency-prepa...ework/emergency-use-authorization#covid19euas
 
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That uncertainty is why the medical establishment shouldn't mount a campaign to scare people into taking an unapproved vaccine/genetic based therapy and coordinate the cancelling of critical clinicians and researchers.

I realize the limitations of the scientific method. Your points are valid. The vaccine promoters and CDC & Co. didn't seem to share your balance and candor when they made claims about the disease and their mRNA treatment. I picked this study because it was published by the NIH and made the specific claims it did.

But, let's assume Spike is toxic. Would it then make sense to inject mRNA to make your cells manufacture Spike on top of the Spike from the viral infection?

The EUA trials threw up red flags for anyone who made the effort to find and review them. And the Dr. Ralph Baric video interview was out there immediately detailing the cleavage sites and the Spike protein's role in the gain of function.

Also, there are recent new pathology studies that claim causation. I'm always hesitant to jump up on them because so many studies are over hyped.
Come on man. Trust the experts. The FDA is here to make sure Big Pharma is honest and doctors snd pharmacists would catch issues before they’d have you take something dangerous. I mean when has Big Pharma or the FDA ever lied




 

FDA Evaluation of Available Safety Data

Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants. These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.
 
If vaccines are so safe and effective why does Big Pharma demand to be immune from damages caused by side affects. ? Asking for a friend.
 
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I think ivermectun had to be said not to work because then big pharma could be sued for pushing vaccines. That whole billions to pennies (ivermectun) will cause people to do unethical things
Who do you think makes ivermectin? Small oharma

It doesn’t work because clinical trials have proven it is not effective.
 
If vaccines are so safe and effective why does Big Pharma demand to be immune from damages caused by side affects. ? Asking for a friend.
May I ask what other industries you think are bad?
What kind of work do you do?

What about “big pharma” is so scary to you .
Spoiler alert from someone who’s done supply chain and contracting for pharmaceuticals-
Vaccines are loss leaders - they aren’t profitable.
Hence why most vaccines are generics
 
Thanks. You're right if course on 1 & 2. It was a review of studies (and other related material) Medicine is science mixed with opinion, and as you pointed out (inferred under your number 4), there's wiggle room for spin, at least to some extent, on every conclusion/interpretation of data. That's where guys like you come in to set up standards.

Your willingness to clarify is by no means unappreciated, and your attempts to make balanced comments are noticed. To your credit you're not going full apologist mode and ridiculing every concern we have.

I'd take exception to number 3. Maybe you can clarify here too.

There were trials performed by Pfizer and Moderna, etc. which were submitted in order to get authorization. I remember a researcher going through them and pointing out adverse reactions to the vaccine. He also pointed out the results showing no statistical difference between vaxxed and unvaxxed subjects, as far as mortality. These studies only went out like like 3 months or so. This was 5 years ago. I will try again to find the video and studies.

Anyhow, I find it hard to believe the FDA or whatever agency, grants EUA without any data whatsoever. I need to confirm exactly what these trials were and to whom they were submitted. Approvals can be denied. There has to be more criteria than just, "We got nowhere else to go". 😉

The fact that these trials were ignored in the media has always fueled my skepticism.
They did submit data
There were massive clinical trials with randomization to placebo world wide.
It’s how the EUA was authorized based on risk vs benefit plus the safety profile

As more data was collected- the FDA later fully approved the vaccines

Of course - now , sadly - the current admin is breaking down the firewall between political appointments and the science and regulatory arms - by putting weirdos like Vinay Prasad in charge of vaccines - and total unqualified and unethical people like David Grier in charge of autism “research “

But - ya know- since it’s Trump - no concerns from the faithful “conservatives “
 
If vaccines are so safe and effective why does Big Pharma demand to be immune from damages caused by side affects. ? Asking for a friend.
They aren’t absolutely shielded from liability-
Only for the disclosed risks provided to consumers.
You want more frivolous lawsuits?!?
 
May I ask what other industries you think are bad?
What kind of work do you do?

What about “big pharma” is so scary to you .
Spoiler alert from someone who’s done supply chain and contracting for pharmaceuticals-
Vaccines are loss leaders - they aren’t profitable.
Hence why most vaccines are generics
Come on man. Trust the experts. The FDA is here to make sure Big Pharma is honest and doctors snd pharmacists would catch issues before they’d have you take something dangerous. I mean when has Big Pharma or the FDA ever lied




Absolutely false, Soufie. Merck has probably made 60 billion dollars off of gardasil since FDA approval 20 years ago.

And this for a vaccine that is 100% unnecessary. It’s a money maker for Merck.

Cervical cancer kills less than 3000 Americans per year, and a large number of those deaths are women who don’t go for routine screenings with their Gyn. This is my arena. I was the product manager and built the market for the testing platform that identified HPV strains and risk for women of developing cervical cancer. In a way, Merck saw the market we created and saw an opportunity to develop a vaccine and make money. I suppose one day the vaccine will go generic, but not after they’ve made billions and billions.

It’s why my wife and daughters will never receive the HPV vaccine because the risk of AEFI is higher than the chance they die of cervical cancer. If your wife goes to her Gyn routinely, she carries no risk.
 
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later that day, he asked the giant eagle deli guy to take a look at a rash he had on his arm and asked how to get it to go away.
they are people who went to school to do what they do, the issue is their industry lobbies to get them put next to the wine aisle so they can normalize selling pharma junk like candy.
 
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Didn't you get enough attention as a child ?

Of course you don't care about Soufs posts or my condition. It's all about you. The narcissism is palpable. Your need to continuously post in almost every thread is proof of that. Im sure you thought everyone was breathlessly waiting on your opinion on Giant Eagle Pharmacists lol.

No one cares about your opinion on Soufs posts,Giant Eagle pharmacists, pharmacists in general, the vaccine,my situation, your paranoia or anything else except you and maybe any other idiots with no lives whose life revolves around the
LR.

Your grandiose sense of self-importance is hilarious.

I don't know how you arrived at the conclusions you did by reading my posts. And you're way off base in what you said about me. You don't even know my personal situation and I don't care to tell someone like you anything about it. I'm sorry for your situation which has obviously affected your thinking. I stand by what I said. I don't trust pharmaceuticals, vaccines, pharmacies, doctors in general, or treatments doctors usually recommend. They need to earn my trust. All of them have failed miserably and the drug industry has lied to Americans. This has nothing to do with me or anything you said. It has to do with common sense, which somehow you seem to lack.

As with souf, I don't care what you think. Your total lack of insight is alarming.
 
they are people who went to school to do what they do, the issue is their industry lobbies to get them put next to the wine aisle so they can normalize selling pharma junk like candy.
I coached 2 girls which seems like just yesterday, and kinda was, who went to Duquesne and are now GE pharmacists. Wonderful girls. Smart girls. Light on experience though. One actually might be at said GE, although I think she’s at the one 10 minutes away.
 
I don't know how you arrived at the conclusions you did by reading my posts. And you're way off base in what you said about me. You don't even know my personal situation and I don't care to tell someone like you anything about it. I'm sorry for your situation which has obviously affected your thinking. I stand by what I said. I don't trust pharmaceuticals, vaccines, pharmacies, doctors in general, or treatments doctors usually recommend. They need to earn my trust. All of them have failed miserably and the drug industry has lied to Americans. This has nothing to do with me or anything you said. It has to do with common sense, which somehow you seem to lack.

As with souf, I don't care what you think. Your total lack of insight is alarming.
This kook does his own research.
 
I don't know how you arrived at the conclusions you did by reading my posts. And you're way off base in what you said about me. You don't even know my personal situation and I don't care to tell someone like you anything about it. I'm sorry for your situation which has obviously affected your thinking. I stand by what I said. I don't trust pharmaceuticals, vaccines, pharmacies, doctors in general, or treatments doctors usually recommend. They need to earn my trust. All of them have failed miserably and the drug industry has lied to Americans. This has nothing to do with me or anything you said. It has to do with common sense, which somehow you seem to lack.

As with souf, I don't care what you think. Your total lack of insight is alarming.

Wow,you just can't help yourself,can
you ? lol
 
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Trials are never done to get a EUA. Trials are done to support eventual, normal marketing approvals. Whatever nonclinical studies or human trials had already been conducted, or were in the process of being conducted and are interimim data from ongoing studies, in support of standard vaccine development were submitted with the EUA application in support of the EUA. The studies weren't conducted specifically for the purposes of obtaining an EUA...defeats the purpose of the "emergency" part.

Every decision is made on a risk/benefit determination. There is always risk for any drug, even aspirin. The amount of risk that is considered acceptable, whether for a traditional approval, an EUA, or even compassionate use/expanded access during non-emergencies, is made weighing both the known and unknown possible risks vs the potential benefits, which take into account the seriousness and probable outcomes of the disease that is being requested to treat. Obviously in a proclaimed national emergency, it is presumed that risk tolerability is quite high because the situation is perilious. But in a normal situation, for example the decision on a traditional approval of a new drug, a high risk would be much more tolerable for a terminal cancer than, say, diabetes which has 1,000 treatment options as adjuncts to diet and exercise.

So the amount of data needed to grant an EUA depends on the perceived risks vs potential benefit and how much data is needed to mitigate the possible risks enough, and how much data strengthens the possibility of a possible benefit, of okaying the EUA application and letting an unknown substance out in the public at a potentially large scale. But, in any declared emergency scenario, the very statuatory requirements of EUAs means the bar of evidence is much, much lower than a traditional approval process.

All the FDA EUAs for COVID, both vaccines and nonvaccine products, and the decision letters, full reviews including lists of reviewers, and other documents are public if you want to actually look at them: https://www.fda.gov/emergency-prepa...ework/emergency-use-authorization#covid19euas

You have to keep in mind that the FDA, and counterparts like the EMA, due to the nature of their legally required responsibilities, have access to all non-public proprietary information of all companies' drug development data...stuff that it can't release because it is proprietary and belongs to companies or researchers...so it has access to much more information on not just individual drugs, but other drugs or vaccines, including competing products in the same drug class, that may have not reached the attempted approval stage or that have even been rejected from approvals (whose information is not public unless the company determines to release it) than the general public. It has a much broader and deeper view of things and potential issues or benefits than anyone outside the Agency, including the individual companies developing the products.
Thanks again. You provided that link for me 5 years ago in a thread. I had asked how they could say the vaccine is safe and you provided the same EUA info. It was informative, but I was searching for data upon which claims and decisions could be based. Then I found the available studies.

The bottom line is drug companies have to submit data and evidence to be granted approval. I found data/trials for BioN tech and Moderna that were provided to the government. Perhaps there were other secret studies, but this was the available information. I don't see why the government should get away with colluding with social media to restrict doctors from calling out information and studies that contradicted the efficacy and safety claims of the CDC etc. and the Rachel Maddows of the media.

Lots of spontaneous abortions so they just dropped pregnant women from these trials. But they later approved the shot for pregnant women based on what? FDA confirmed they did not independently verify any of the data provided by Pfizer and Moderna. People should be allowed to know that the duration period of any immunity was not confirmed, or that the results based on measuring only PCR tests was spurious ( yet people still claim that x number of lives could have been saved. )

All this is to say that an EAU given basically because they got nothing else shouldn't be portrayed as safe and effective. And if they argue that it is, then they should allow debate. They didn't.

Again, all you can do is your job. None of what they did can be laid at the feet of ethical researchers like you.

 
I coached 2 girls which seems like just yesterday, and kinda was, who went to Duquesne and are now GE pharmacists. Wonderful girls. Smart girls. Light on experience though. One actually might be at said GE, although I think she’s at the one 10 minutes away.
I don't see why Giant Eagle gets a bad rap here. I don't use it but I did for a year maybe long ago.

It's a big store. I'd think Pharmacists would want to work there due to its size, but who knows. Being large, they seem to get a lot of interns. So that might give folks a base impression.
 
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I don't see why Giant Eagle gets a bad rap here. I don't use it but I did for a year maybe long ago.

It's a big store. I'd think Pharmacists would want to work there due to its size, but who knows. Being large, they seem to get a lot of interns. So that might give folks a base impression.

Dude was just trying to make himself relevant. If i said I went to Walgreens he would have tried to rip them and say he knew Walgreens pharmacists and they were bad lol.
He needed a way to inject himself into my post.
 
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I coached 2 girls which seems like just yesterday, and kinda was, who went to Duquesne and are now GE pharmacists. Wonderful girls. Smart girls. Light on experience though. One actually might be at said GE, although I think she’s at the one 10 minutes away.

I doubt 1985 knows them. I doubt he knows any GE pharmacists. Judging by the fact he spends his life on the LR,it doesn't look like he gets out much to meet anyone. I shouldn't criticize though. Incels have a tough life according to what I've heard.
 
They did submit data
There were massive clinical trials with randomization to placebo world wide.
It’s how the EUA was authorized based on risk vs benefit plus the safety profile

As more data was collected- the FDA later fully approved the vaccines

Of course - now , sadly - the current admin is breaking down the firewall between political appointments and the science and regulatory arms - by putting weirdos like Vinay Prasad in charge of vaccines - and total unqualified and unethical people like David Grier in charge of autism “research “

But - ya know- since it’s Trump - no concerns from the faithful “conservatives “
Bull hockey. Prove it. The initial trials that were available at the time were garbage. Show me the money. It was an emergency. HTF did they have time to do these massive clinical trials?

And I with CrazyPaco answered my spike protein hypothetical. If toxic, it was risky to get the shot when you were infected. JMO. And my opinion admittedly is of little value. 🤷

And you're basically saying @CrazyPaco is wrong? Alrighty then.

 
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I doubt 1985 knows them. I doubt he knows any GE pharmacists. Judging by the fact he spends his life on the LR,it doesn't look like he gets out much to meet anyone. I shouldn't criticize though. Incels have a tough life according to what I've heard.
I don’t know why but I always thought 1985 was your buddy. Now this little back and forth made me remember that it was a different guy.

But in any event, can we all please get along? Lol.
 
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