ND String Puller's Link
I pointed out how in Bet med we have all sorts of liberty for off label use. But regulations prevent such issues on humans.
One thing is for certain, we still do not know hardly anything about the damn mess. The data is being manipulated all the time, and corruption will likely prevent us from ever really knowing…
Gaslighting is the best way to blow your cover and prove you don't actually have an argument of your own.
That's because it's easy to figure out if you completed a basic high school education. Sorry doc's, you're not the only ones that can process and understand the data...
Do you even grasp the *concept* of 'vaccination' ? Or is the static too loud?
I don`t wear masks, don`t practice the mythical/ridiculous 6' social distance rule....so far so good.
This so called shot is NOT a vaccine.....mRNA using a synthetic to initiate an immune response does not meet the definition of a "vaccine". Why else would the CDC change the definition of "vaccine" last week. Don`t even get me started on which "not a vaccine" was actually approved by the FDA.
What happened to the left`s mantra....."my body my choice"?
Nothing. It's just become a popular mantra for the right now. Irony is beautiful.
You call people 'sheep' but who are the lemmings following the anti-vax preachers off a cliff? Happy landings!
“Approximately 97% of people with severe disease from the delta variant are unvaccinated,” she says. “That gives you an idea of how effective these vaccines are. I think that number is a point that cannot be overemphasized.” "
I`m just glad you admit it`s not a vaccine. When was the last time you heard of someone having a mild case of Polio or Smallpox....or your dog having a mild case of rabies?
You got the jab now you have a monkey on your back for life....well done.
Gosh dang it Matt, I’ve had to many bud lights to argue about irony tonight
Here's the thing - anyone who does not get vaxxed, and dies from covid, well, the Democrats figure that's one less vote for the Republicans. (I would love to see how covid deaths break down per party affiliation...) And *they* are sitting there looking all serious while they laugh up their sleeves.
Got data to back that?
Really? BOTH sides want POWER. Both sides know HOW to get it - MONEY. And the money is in military spending. If you were paying attention last week, BOTH sides were pushing for MORE spending. Defense contractors get rich, they kick back a percentage to RE-election PACs, (yes, on BOTH sides), defense contracts get parcelled out to 'friendly' congressional districts, rinse and repeat.
Did you ever look at how many states make parts for that POS F-35?
Ike warned us about this bullshit. January 1961, Eisenhower's Farewell Address. Probably the most important document in modern history, and bet your ass it is NOT being taught in schools, regardless of which way the district swings.
Democrats. Republicans. Whores of Mammon, every one of them.
That speaks volumes on this subject.
Grey Ghost's Link
Nonsense. Per the FDA (see link for the official announcement): "Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older."
" The creator of the mRNA technology, Robert Malone...."
More nonsense. Malone is just one of hundreds who contributed to the development of mRNA vaccines over decades of research.
I didn't read the the rest of your rambling post, since you missed badly on your first 2 points.
Why are liability protections still in place for an approved "vaccine". "Cominarty" is not expected to be produced until late 2022-2023.
There have been legal scholars and large law firms that looked into the legal ease of the "approval" and it appears "legally" the citizens have been hoodwinked again.
Well, that’s straight up wrong.
It is an identical product with the same formulation. To suggest Cominarty has never been manufactured is misleading at a minimum. It’s the same vaccine. The only meaningful differences are how it is legally treated and how it is being marketed.
“Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
Furthermore, since it is an identical product chemically speaking, it has been produced and studied extensively.
“Follow-up data from this ongoing clinical trial was analyzed by FDA to determine the safety and effectiveness of Comirnaty. The updated analysis to determine effectiveness for individuals 16 years of age and older included approximately 20,000 Comirnaty and 20,000 placebo recipients who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Overall, the vaccine was 91% effective, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
The safety was evaluated in approximately 22,000 Comirnaty and 22,000 placebo recipients 16 years of age and older. More than half of the vaccine and placebo recipients were followed for safety for at least four months after the second dose. After issuance of the EUA, participants were unblinded in a phased manner over a period of months to offer placebo participants Comirnaty. Overall, in blinded and unblinded follow-up, approximately 12,000 Comirnaty recipients have been followed for at least 6 months.”
It blows me away how misinformed some Bowsiters can be. Even after our own experts, like Ike and Mike in CT, have taken time to explain the facts, they still cling to their misinformation. And worse, they try to spread it.
I’d say I’m shocked, but unfortunately I’m not surprised. It reinforces how real the struggle is, though, when people do not even get the most basic of facts.
The shots being given ARE NOT Cominarty, they are BioNTech.....the term "interchangeable" is not a legal term.
The shots being given still fall under EUA and the makers are still under liability protection. Somehow you think that`s a small point. Large law firms have gone through this with a fine tooth comb in preparation for possible litigation. The name change from BioNTech which actually sounds like a medicine to Cominarty.....sounds like a candy bar....should tell you everything you need to know. You have been played.
It`s sad our citizenry isn`t more informed and so easily misled.
No, it isn’t. Again, people not understanding basic facts. BioNTech is a company, not a product.
It`s sad our citizenry isn`t more informed and so easily misled.
Coming from someone who doesn’t even understand BioNTech is a company that developed the vaccine with Pfizer, this is one of the most ironic of statements I’ve read.
Where to begin. BioNTech is the name of a company, and not a product. Too many of you seem to be misunderstanding this very basic point.
The whole point behind rebranding the vaccine developed by Pfizer and BioNTech and giving it a name is the fact that it can now be legally marketed and advertised.
Continuing the EUA has everything to do about inventory management and vaccine distribution, and nothing to do with trying to pull one over on the American public.
As someone once said, “It`s sad our citizenry isn`t more informed and so easily misled.”
If you change the name of an apple, it's still an apple. Cominarty and the Pfizer vaccine are the SAME formulation, and can be used interchangably, per the FDA.
As for your liability concerns, you can thank GW Bush for that one. He signed the PREP Act into law that allows the federal government to provide liability immunity to drug manufactures in circumstances like these. Which, btw, is probably why the vaccines are free to everyone.
You see, unlike you apparently, I don't have an inherent distrust for our government, nor our medical community. I applauded Trump when he rolled out Operation Warp Speed to streamline the development, manufacturing, and distribution of the COVID vaccines. I honestly think that the record short timeline that it took to bring us the vaccines will go down as one of our medical community's greatest achievements in the last few decades.
I stand by my statement of people being "hoodwinked" and "uninformed".
The FDA receives 45% of it`s funding from fees from Big Pharma.....65% of the fees from human use medical drugs fund the FDA. Do a quick search of how many FDA officials leave the FDA and are now working for Big Pharma.
This so called "vaccine" doesn`t even have the actual virus in it....it`s a synthetic and doesn`t meet the definition of a "vaccine".
You are correct about one thing.....no I do not trust the government that funded and help create the virus that killed millions. By the time it`s all said and done, the US government will have a hand in Hitleresque death tallies. So no I do not "trust" big government.
But you probably still believe it was bat soup that created this virus...so....
They are the SAME product. The “Pfizer” vaccine was developed in conjunction with the company BioNTech. It has been produced, administered, and tested and this vaccine is now fully approved by the FDA. It has now been rebranded as the product Cominarty after extensive testing in human beings - just because the name changed doesn’t mean that it is something “different” in all the ways that matter medically speaking. This really isn’t that hard.
And yes it is a vaccine. The overall definition of what a vaccine is has not changed. It is a still a “substance used to stimulate the production of antibodies and provide immunity against one or several diseases.”
Stop with the misinformation and get your damn facts right. This is just sad.
ND String Puller's Link
Spike, I see the same thing on both sides. I tend to believe whoever comes in with hard data. Not bluster, not arguments 'ad hominem'.
it's even worse. advil and ibuprofen can be and often are manufactured by different companies. in this case its the same company, same vaccine, they just gave it a legal name. ...same damn parents...same damn baby...now it has a legal name.
Haha, the current attempts at restricting abortion and voting suggests otherwise.
Make it easy. How are voting rights being restricted in Texas Facts only please, based on what was passed as law?
Make it easy by twisting the discussion to limit it only to bills that have been passed, only bills that relate to voting rights, and then only those passed in Texas? Given the previous comments to which we were responding , that seems to be a really intellectually dishonest question.
The GOP exists outside of Texas, the things they desire to do are not fully embodied in passed legislation, and those desires extend beyond voting rights.
Let's talk about the abortion law that Texas recently passed which, as I understand it, bans abortions after 6 weeks of pregnancy (which is sooner than many women learn they are pregnant), so it could be construed as a de facto abortion ban. While I am generally pro-life, the COVID/vaccine discussion has opened my eyes to how important it is to let people to make personal decisions that affect the lives of others. As such - and I am sure you are on the same page - people should be allowed to make healthcare decisions personally without consideration of how they impact others (in this case, an unborn fetus).
Tangentially, I find it ironic that conservatives are generally both pro-life and anti-welfare - so in many cases they both want to force women to have babies they do not want/cannot afford and then desire to eliminate the social safety net that they would need.
On the voting front, the grand irony is that most legislative changes were initiated by people who have bought into Trumps lies surrounding the 2020 presidential election having been fixed (of which I have seen 0 evidence). That is flatly stupid.
Since the election, GOPD politicians in 43 states have proposed ~250 laws to change the voting process. Much of this legislation was designed to limit mail in ballots, limit early in-person and election day voting and impose stricter voter ID requirements. While I am on board with ID requirements, from an outsider's perspective much of the other proposed legislation appears to be designed to limit access to low income/minority voters. In my opinion, that is flatly un-Americans.
One only has to look at some of the aspects of Georgia's voter law that subtly makes it more difficult for some people to vote and also makes the process of evaluating any contested ballots more subject to a partisan process. Again, that seems patently un-American.
If it makes you fell better, I think Biden's comments about these efforts being "Jim Crow 2.0" are hyperbolic and inflammatory, but I think that in a subtle way he is directionally correct as to their intent.
"We support important freedoms", like the right to smoke menthol cigarettes and bike without helmets. Lah dee dah. When the _hard_ choices come down you're as authoritarian as the Taliban.
Put religious beliefs aside..a child in the womb is a person unto themselves. ..real science proves that. You have no argument other than the fact you believe we have a right to decide what class of people have no rights. Kinda like the pro slavery crowd declaring black people were not human and equal to the white race. Whether you are a Christian, athiest or whetever, natural law tells us certain things are wrong. You just dont wantvto accept it
I could easily do that but you're clearly one of those guys who is too stupid to recognize how stupid you are. Let's start with two easy ones. First, the vaccine was not approved by the FDA through proper channels. This is a shell game by the FDA and CDC. Vaccines can not be approved without years of clinical trials and completing "stages" of testing that have been conveniently scrubbed from the FDA and CDC websites so people won't question why they are not following their own protocol which has been in place for years. The vaccine that was magically approved is not one and the same as the one being given currently. They just want you to think it is so ignorant people will think it's safe to get the unapproved vaccines now, even though they are far from safe.
Second, Robert Malone did indeed invent mRNA technology. The only people claiming he didn't are liberal media outlets, you know the ones you get your "facts" from.
You'll still cling to your ignorant and incorrect assertions, claiming them as "fact" when they are anything but. You do not have the ability to think critically and are the real problem with our nation right now as you blindly trust our government, the media, and other agencies who have corrupt and sinister agendas and who lie every time they open their mouth. Thankfully, it appears that the majority on this thread are far more intelligent than you and recognize the truth. Darwin was talking about people like you. Take the shot.
This is why I won't debate it. You can not be for 'rights' when you casually dismiss the rights of half the population. And sorry, all the arguments you will make -next- about sex will be based on religious beliefs. So...
Not impressed when 'conservatives' adopt and then abandon libertarian principles to suit their needs.
Hypocrisy, as usual.
Because while I strongly support vaccination, I prefer shaming those who oppose it to mandating it. And while I support 'abortion rights' I strongly prefer shaming women who fail to use proper birth control.
Be careful what you wish for.
Unless it's your daughter? Downs?
The law defining right versus wrong is written in the Ten Commandments. End of story. No interpretation needed.
EXACTLY what YOU are doing, putting the unborn against the already-living. And disenfranchising HER.
This whole statement is demonstrably false. Medicines, vaccines or otherwise, do not all require "years" of testing, and the fully approved Pfizer vaccine went through all the normal FDA processes, including the three phases of clinical trials.
Second, Robert Malone did indeed invent mRNA technology. The only people claiming he didn't are liberal media outlets, you know the ones you get your "facts" from.
He was one of the first and one of many, but there are others who the scientific community (not the liberal media outlets) give more credit to with respect to mRNA vaccine technology. As GG rightly points out, there were multiple players involved and he was but one.
So you might want to look in the mirror when you discuss "ignorant" and "incorrect" assertions, Dave.
What gives the gov't of Texas the authority to decide?
Look. Abortion sucks. It is not the easy choice the religious right makes it out to be. (Ask a women's health counselor about that.) But when the option of providing all women (and all men) with easy access to birth control is brought up, the religious right either comes out as anti-sex (good luck with that!) or they trot out the 'socialist medicine!' play. Either way, they get to feel good about themselves without putting any money up. I don't know which is worse, the phony piety or the plain damn cheapness.
You want to cut down on abortions? Pony up. (And sorry, no, poor women will not stop having sex with or without protection, just because it pleases you.)
The Constitution is also not an enumeration of all of the rights to which we have been endowed. And the SCOTUS has ruled that the Constitution does protect the right to an abortion (citing the 9th and 14th Amendments).
Wow. I think you're a racist and want to deny minorities the right to vote and affordable health care.
A lot of things don't 'match up with the Constitution'. that's the same silly argument anti-gunners use about the 2nd and 'assault rifles.' The Constitution and BoR was never intended to be a *comprehensive* list of the rights we enjoy. The Ninth Amendment, reads as follows: The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people. Hence the 'right to privacy' - and hence abortion - affirmed by SCOTUS in Roe v wade.
So you are supportive of mask and vaccine mandates?
It has a lot to do with them having been treated like lab rats by our government in the Tuskegee syphilis experiments and others.
No wonder this country is such piss poor condition.
"No, the COVID-19 vaccines do not contain any aborted fetal cells. However, fetal cell lines – cells grown in a laboratory based on aborted fetal cells collected generations ago – were used in testing during research and development of the mRNA vaccines, and during production of the Johnson & Johnson vaccine. "
From my understanding, no, it's not true. They use lab grown stem cell clones that descend from fetal cells collected 50 years ago. They are called "fetal cell lines". Basically, it's like keeping a heirloom tomato strain going. The specific fetal cell line used in testing the Pfizer and Moderna vaccines is called HEK 293.
Disclaimer, I'm not a scientist, doctor, nor a contagious virus expert. But, I can search and read articles from reputable sources to educate myself.
So, I guess you're against the vaccines for smallpox, rubella, Hepatitis A, and rabies, too, eh? They were all tested on viruses grown on fetal cells.
The obvious reason they test vaccines using lab grown fetal cells is because the viruses being targeted affect human cells, and not necessarily animal cells.
Speaking of brain washed and manipulated, what leads you to believe that long-terms side effects are likely from a 1 or 2 dose vaccine? We are not talking about a daily medication that builds in the body over time. Vaccine side effects generally present within ~6 weeks of being administered. There have been almost 6B doses given worldwide, so there is robust data on which side effects have been observed and their relative frequency.
In fact, I recently read an article from someone in the medical field saying that we have a more robust data set for the COVID vaccines given their broad-based administration than we get from the clinical trials done to support FDA approval of other drugs.
Just another straw man....
Who is saying "my body, my choice" only applies to abortion? If one approaches both COVID vaccination and abortion from the overarching perspective that life is sacred and should be protected, they should be logically consistent and apply that to both (or neither). Invoking it on their own behalf but rejecting other's ability to do so comes off as massively hypocritical.
"Who is saying "my body, my choice" only applies to abortion? If one approaches both COVID vaccination and abortion from the overarching perspective that life is sacred and should be protected, they should be logically consistent and apply that to both (or neither). Invoking it on their own behalf but rejecting other's ability to do so comes off as massively hypocritical. "
My body my choice for abortion in fact ends up killing 50% of the people involved in the activity. It's my body I can do what I want.
Yet when it's my body and I don't want to get a forced vaccination, you're telling me I can't do what I want...despite virus killing far less than 50% of the people involved. Like less than 1%...
Hah, that couldn't be further from the truth. I just wish you would be logically consistent, keep up with the news if you are going to post up conspiracy theories on breaking news that pretty much everyone else knew about 3 months ago, and brush up on your math skills.
Do you support the paid-informant, legal-harrassment system that Texas has put into law? Because that crap is straight out of the KGB playbook. Or the Stasi. Tyranny at its damnedest.
The people from Texas that I've 'met' on the internet here and elsewhere are good folks, but they have started a culture war that I fear is going to burn them badly. I hope I'm wrong, both for them and because it might spread worse than any physical disease.
OMG!! Once again, ignorance shining bright. You are 100% WRONG on this. You might wanna spend some time investigating the truth rather than watching CNN. Do tell, where do you get your "facts?" Straight out of your a$$??? This is the problem in this country today. People as ignorant and uninformed as you are making decisions by casting a ballot that affect those of us with intelligence. Second, while Malone may have been "one of many" who were instrumental in development of mRNA technology, he was certainly one of the most influential. So, your claims of otherwise just show your ignorance and incapacity for critical thinking and exploring the truth. Typical libtard, use baseless arguments and false information to defend your position when it does anything but and generally shows your lack of intelligence.
You are actually the one spreading misinformation. Why don't you tell us Mr. KNOW-IT-ALL what the phases of vaccine testing and approval are. Then, explain how it's possible that any vaccine could magically get approval in less than a yr when following the FDA's own long and established guidelines. Then explain to us what your "qualifications" are, aside from being able to regurgitate propaganda that you get from Google and Facebook.
Here's one for you. NONE of this was done under proper scrutiny or duration, BTW, for the COVID vaccines.
First, Ivermectin is not simply horse-paste. It was developed nearly 50 yrs ago as an anti-parasitic and also has been found to have significant anti-viral properties. It has a very long and SAFE track history in treating a variety of conditions in HUMANS as well as animals. Like HCQ, it has an excellent safety profile and is very effective and inexpensive at treating and PREVENTING COVID. Many physicians with integrity know this and have been treating COVID patients now for months with excellent results. What's that you say, you didn't know that because CNN FB, and Twitter didn't tell you that??? Fraudci and the NIH don't want people to know this or use it because THEY'RE NOT GONNA MAKE ANY MONEY OFF IT!! They are sinister and corrupt and the sooner some of you recognize this, the better off we'll all be. Fraudci, the CDC, NIH, and FDA ARE NOT YOUR FRIEND, despite what many naive people would like to believe.
Again, straight up wrong. Directly from the FDA website (which is hilarious that you linked to because if you spent any time looking at what was done you'd realize how far off base you are).
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
You provide a link to the steps necessary to obtain vaccine approval, all of which were followed as required as it pertains to the Pfizer/BioNTech vaccine. The other links you provided are nothing more than opinion pieces, from some mighty dubious sources I may add (the New Eastern Outlook? LOL).
But I'll give you another chance and ask the same question others have, what specifically was done outside of the FDA guidelines/requirements as it pertained to the approval of the Pfizer/BioNTech vaccine? Posting a link to all the steps that were actually followed doesn't really help your case.
Mike in CT, who has 30 years of experience in the infectious virus field, has already explained, in depth, how the usual FDA approval process was streamlined, largely due to Trump's multi-billion dollar Project Warp Speed, to make Covid vaccines available in record time. I'm sure you'd be praising those efforts, if he were still in office.
After decades of research and development by hundreds of scientists around the world, If you still think Robert Malone was the sole inventor of the mRNA technology, there's not much I can do but shake my head and ignore you.
"[Comirnaty] is absolutely not available. So the little trick that they have done here, is [the U.S. Food and Drug Administration] issued two separate letters for two separate vaccines. The Pfizer vaccine, which is what currently available is still under Emergency Use Authorization…
The product that’s licensed [by the FDA] is the BioNTech product, which is substantially similar but not necessarily identical. It’s called Comirnaty. And it’s not yet available. They haven’t started manufacturing it or labeling it."
You do realize he's walked back that statement right? He admitted he was completely wrong. Now you can go ahead and do the same. We're waiting.
"Malone quickly conceded his statement on the Bannon show was wrong. “When one is doing rapid analysis on the fly, one does not always get everything right,” he told The Fact Checker. “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.” He said the statements we received from Pfizer and HHS “are consistent with my current understanding.”
What was streamlined was essentially the procurement and manufacturing aspects related to vaccine rollout.
In addition, some of the testing was done in parallel steps, not sequentially as would have been typical. None of these steps related to testing or clinical trials were bypassed or shortened prior to full-FDA approval.
If I'm keeping track, the "proof" that Dave provided that we are wrong and ignorant is:
- a quote from Dr. Malone that he walked back and admitted was wrong
- a list of the steps required to obtain vaccine approval, all of which were followed by Pfizer/BioNTech
- opinion pieces published by Russian media outlets
Nor is there a need for EUA of injections if the disease is not as deadly as they claim it to be… 94% of “Covid deaths” died with it versus the 6% that died from it.
Not to mention the PCR test being run twice as many iterations as the standard test procedure and on a mixed sample baseline that doesn’t even include an isolated SARS2 (COVID-19) virus…
Suppression and censorship of information to slant the narrative and push the FEAR. Power… and Money.
This statement falls somewhere on the spectrum between: "gross misrepresentation" to "patently false."
For those truly keeping track:
a quote from Dr. Malone that he walked back and admitted was wrong NO HE DIDN'T
- a list of the steps required to obtain vaccine approval, all of which were followed by Pfizer/BioNTech NO THEY WEREN'T
- opinion pieces published by Russian media outlets AND, NO IT ISN'T.
SO CRAWL BACK IN YOUR HOLE AND BRING SOME LEGITIMATE FACTS AND INFORMATION BECAUSE YOU'RE CLEARLY AN IDIOT.
And for those of you with an open mind and an ability to research truth and credibility, do a simple search regarding this clown's assertions above and you'll see they're demonstrably false. After that, you can surmise as to the credibility of the rest of his ludicrous claims.
LOL!!! Yes, he did. He literally said the following when pressed on his statements regarding Cominarty being some separate vaccine and somehow playing a trick on the public.
“When one is doing rapid analysis on the fly, one does not always get everything right,” he told The Fact Checker. “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.” He said the statements we received from Pfizer and HHS “are consistent with my current understanding.”
Here are the statements that Dr. Malone ADMITTED was correct.
From Pfizer: “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”
“The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA,” Castillo said. “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.”
From the HHS: “There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,” confirmed an HHS spokesperson."
Again, he was wrong. And he admitted it. Your links and "proof" have been debunked by the very source you are citing. Not sure why you're sticking to this story when "ya boy" Malone admitted it was BS.
a list of the steps required to obtain vaccine approval, all of which were followed by Pfizer/BioNTech NO THEY WEREN'T
Yes, they did. But I'll ask for the third time, what steps were not followed?
opinion pieces published by Russian media outlets AND, NO IT ISN'T.
The lesson here is to not cite unknown sources. I'll help you out with this one..."New Eastern Outlook, NEO, is an English-language website, managed by the Russian Academy of Science’s Institute for Oriental Studies." LOL!!
SO CRAWL BACK IN YOUR HOLE AND BRING SOME LEGITIMATE FACTS AND INFORMATION BECAUSE YOU'RE CLEARLY AN IDIOT.
For now, I'm done here. I'm going hunting. You should try and do the same rather than continue to spread lies and misinformation. Luckily, the majority see you for what you are.
I'm not just listening to pharmaceutical companies or HHS. The FDA has been pretty clear that, as it pertains to "structure, sequencing, and make-up" of the vaccines, these are equivalent products. Straight from the FDA: "Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart." So, again, you're wrong, however you want to slice it.
Suggesting these are two separate vaccines as you are doing and that they are also subject to different legal protections has been debunked on both accounts - they are the same medically speaking, and thanks to the PREP Act, they are subject to the same legal protections. Again, your hero Dr. Malone has admitted to this fact and that he was wrong.
Second, the FDA has conveniently removed the timelines from their online description of the phases of vaccine testing because it clearly showed that there was no way that the vaccines could be tested and receive FDA clearance within a year. Even Fraudci and countless other bureaucrats were saying this all along until they needed to change their narrative. Warpspeed did nothing to change this
Hard to remove something that never existed. There are rules of thumb regarding how long vaccine development takes, but there is nothing set in stone. The FDA may give some timeframes, but they have this to say on clinical trials, "As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design."
Furthermore, Faucci and others were quoting what was typical, not what was capable of being done in a pandemic where there is significant federal help available. Clinical trial phases were combined, allowing for accelerated Phase I, II, and III trials. There was a multitude of case data to assess vaccine efficacy thanks to the pandemic. Lastly, manufacturing capacity was scaled up during the clinical trials because the financial risk was mitigated by federal funding thanks to Operation Warpspeed. These are undisputable FACTS, and it is indeed what allowed for an accelerated timeline of vaccine development and approval. No steps were skipped. Steps that were taken in series were taken in parallel. This is what was done, and this is what Operation Warprspeed helped enable. No steps were skipped, no corners were cut.
Again, you're flat out wrong and you show a fundamental lack of understanding around what the vaccine is, what the approval process is, and what Trump's Operation Warpspeed did to accelerate the timeline.
As far as people like me...I'm not ignorant or corrupt. I'm right.
I'm often reminded of the words of a smart man when I read these threads. He said, "never argue with a fool; onlookers may not be able to tell the difference."
What's even more disturbing than how people, like Dave, cling to their misinformation is how few people are willing to call them out on it. I don't give a rat's ass what political jersey you wear. But, if you deliberately let misinformation slide just because it's coming from someone on your side of the isle, you are a complete worthless disgrace to me.
By the way, the Nobel prize was not for treatment of COVID.
I think Mike in CT said something about ivermectin preventing virus replication but you have to take it early in the infection. Earlier than you have symptoms. And that it might not be effective after symptoms and that’s the issue? Maybe Mike will jump in here.
Dave also thinks Cominarty and the Pfizer-BioNTech vaccine are separate drugs, so…
My friends that used it did 1cc per hundred pounds, zinc, vit. D, Zpac , B12 and a steroid. Recovery was very fast. I only know about 9 people that did that but it worked for them. Probably need to expand the sample group :)
am i getting that right?
If there is an effective treatment, the Emergency Use Authorization for the injections will no longer be valid.
There appears to be a number of safe, effective prophylactics and treatments including vitamins, ivermectin, HCQ, and monoclonal antibody treatments. All being suppressed by the MSM and social media. Hell, have heard that pharmacists have refused to fill doctor’s prescriptions for ivermectin and HCQ even when they have it.
The current administration has, in the last week, precluded distribution of monoclonal antibody drugs for treatment to Red States like Texas and Florida where they have been used for treatment of both vaxed and un-vaxed.
The injections are getting pushed for reasons that do not pertain to any individual’s or group’s health…
Tavis, can you show your source for this information? Thanks.
From your above statement:
“This statement falls somewhere on the spectrum between: "gross misrepresentation" to "patently false."”
The CDC provided the data. From their own report:
“For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.9 additional conditions or causes per death. The number of deaths with each condition or cause is shown for all deaths and by age groups. Values in the table represent number of deaths that mention the condition listed and 94% of deaths mention more than one condition.”
Is this source of data on Covid wrong?
Now, on to dispelling your idiocy. Unfortunately, the possibilities are vast and I'm not sure where to begin. I think I'll start with the vaccine fraud.
Let's assume you are correct in that the FDA did indeed approve Cominarty and that it is one and the same as the EUA(and that remains to be proven), your lies about timelines never existing is a complete and utter lie and just proves your ignorance regarding medicine and pharmaceuticals. While there may not be an "exact" timeline in the sense of months, years days etc for when a trail phase is complete, there are parameters which were not followed even closely with regards to the current vaccine testing. https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
Anyone with half a brain could read this and look at the phases of vaccine approval and research and see there's no possible way these parameters and phases were followed.
Additionally, please explain to us why the placebo arm of the trial was discontinued early on when there was no rational reason for doing so other than to fast-track the approval and make the vaccine appear to be effective when it isn't. For those interested in the truth, pay particular attention as well to Phase 3 testing which is geared toward proving that the vaccine PREVENTS infection with the pathogen(which this one DOESN'T) and whether it is safe(which this one IS NOT). Even the vastly underreported VAERS data showed well over 400,000 serious adverse events including over 7000 deaths after taking this vaccine. This is more than there were for all 70 other vaccines for 30 yrs combined and yet this vaccine gets magical fast-track approval???? These are only the adverse events REPORTED. There are far more that have not been reported. We also know that the vaccine DOES NOT prevent infection. In fact, this vaccine is the sole reason for the continued development and spread of variants through Antibody Dependent Enhancement. Not only is it leading to the development of mutations and variants, but those "vaccinated" but not truly protected from the virus are actually the primary spreaders. This was confirmed a few wks ago in a study out of Oxford which showed that VACCINATED health care workers carried 251 times the viral load as unvaccinated workers in nasal swabs. It is also a lie that the vaccinated are not ending up in hospitals and/or dying. This is the corrupt CDC and hospitals manipulating numbers again by claiming that someone who was recently vaccinated for COVID and ended up dying, died of COVID itself rather than the vaccine. What is most disturbing about this whole thing is that people are being denied effective, cheap, and life-saving therapeutics in order to perpetuate fear and the pandemic to make money. Ivermectin, HCQ and other therapeutics have been PROVEN effective at treating COVID and yet they are being denied by corrupt hospitals and the FDA for none other than corrupt and sinister reasons.
Dana, the answer to your question is simple--the thousands of physicians who recognize the fraud and are trying diligently to inform the people and treat them appropriately despite the censorship and narrative being perpetuated by clowns such as BEG and GG.
I'll let you in on a secret of the medical industry. The FDA, CDC, and NIH have always been corrupt and those physicians with any firsthand experience with them have known this for years. They are not looking out for the best interests of mankind. They are a political organization with only one objective--MONEY.
From the FDA "Emergency Use Authorization for Vaccines Explained"
"Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives."
That last part is important about no adequate, approved and available alternatives.
It appears that there are a number of adequate and available alternatives. The FDA has not approved them. Think it might be about money?
Many doctor's accounts and medical papers stating that there are alternative safe and effective preventative and treatment measures.
The mRNA injections have, thus far, proven to be ineffective in preventing people from catching, transmitting, being hospitalized, or dying of Covid. There have been more deaths reported from these injections than for all other vaccines since 1990. Over 675,600 adverse effects reported in the US to the VAERS system run by the CDC. And, based on a Harvard study, "Electronic Support for Public Health-Vaccine Adverse Event Reporting System", less than 0.3% of all adverse drug events and 1-13% of serious events are reported to VAERS.
No, the data is correct. Concluding from the data that people died “with” COVID and not “from” COVID is what is somewhere between grossly misrepresented to flat out false. The reality is had these people not caught COVID, they wouldn’t have died when they did. That is why COVID is listed as what killed them.
There is no need to assume anything. I am correct.
While there may not be an "exact" timeline in the sense of months, years days etc for when a trail phase is complete, there are parameters which were not followed even closely with regards to the current vaccine testing…Anyone with half a brain could read this and look at the phases of vaccine approval and research and see there's no possible way these parameters and phases were followed.
I’ve asked you five times now to tell what parameters have not been followed. All of the clinical trial information associated with Comirnaty approval is publicly available, as is information on the broader approval timeline. You keep saying steps weren’t followed but have failed five times now to enumerate a single requirement that were skipped or single instance in which a corner was cut.
The parameters were followed. The information is out there. Case closed.
Ivermectin, HCQ and other therapeutics have been PROVEN effective at treating COVID and yet they are being denied by corrupt hospitals and the FDA for none other than corrupt and sinister reasons.
This statement here might just take the cake for the funniest of all your points. Outside of poorly designed studies and anecdotal information, there is no proof regarding ivermectin, HCQ, etc being effective in treating COVID. Clinical trials are underway for ivermectin, but are not complete. So, unlike say Comirnaty which has been tested for effectiveness for COVID and approved as such by the FDA, any “proof” of ivermectin’s effectiveness has not been validated by robust clinical trials and is akin to old wives’ tales at this stage.
Like Matt said earlier, I should be careful when engaging with idiots as outsiders may struggle to tell the difference. You’ve had ample time to provide proof to back up your wildly incorrect assertions. You haven’t. Engaging with you further is not worth the time.
...and the "scents" that it makes is that of pure horse manure.
Could be interesting….
Honestly, you'd be better off just putting another bumper sticker on your Subaru. ;-)
That’s rich. I’ve asked you multiple times to layout what parameters were not followed. You haven’t. I told you all of the Pfizer approval information is out there publicly available for BNT162b2, the vaccine now known as Comirnaty, but not surprisingly you won’t speak to it.
Phase I preliminary results upon which EUA was granted. Further clinical trial details available as well at the link.
Phase II/III results which were the basis of full FDA approval.
Summary basis for regulatory action upon which FDA full approval was granted, which includes summary of the above clinical trial phases.
All steps complete, all required parameters met. You are confusing vaccine approval during normal time periods with what can happen during a pandemic whereby there are significant more cases available to test the safety and efficacy of these vaccines. This leads to a much faster assessment process as loads more data is available on a much faster timeline.
I should apologize for pushing you on providing proof that these steps weren’t followed. That is impossible to do because that proof doesn’t exist. I thought maybe you’d take the chance, like your buddy Dr. Malone, to admit you’re wrong. I see I gave you too much credit.
For those interested in the truth:
Proof of PCR Fraud:
Proof of the vaccine side effects:
For those keeping track, I've produced at least 10 links to truthful, factual, and VERIFIABLE information proving what a lying imbecile BEG is. Meanwhile, he has yet to provide a single one, other than quotes taken out of context or likely made-up, documents from a corrupt pharmaceutical company, and the smoke that blows out of his ass.
My proof is the clinical trials conducted on tens of thousands of people, followed by the literal billions of people now being monitored as part of the vaccine rollout. It's all there in the documents. Your argument seems to be "Pfizer is lying" or "Pfizer is making up data," which again you've provided no proof to back-up (beyond unconfirmed, unsubstantiated wives' tales from questionable sources).
Do tell us how no other vaccine has ever been approved in less than 4 yrs and yet somehow this one is approved in less than 1. There is NO WAY that the parameters meeting testing can be adequately completed in less than a yr. How do you possibly evaluate for birth defects, effects on pregnancy, long-term effects not readily identifiable in less than a yr of testing? Simple. YOU CAN'T!!!
I told you, but you're too dense to comprehend. You can throw typical timelines out of the window for COVID vaccine development. Development typically takes so long because you need to ensure you have a robust data set to evaluate the efficacy and safety of a vaccine. When you are in the midst of a global pandemic with literally 100s of millions of cases occurring a year, it's A LOT easier to generate the appropriate dataset to do so. This can't be done outside of the context of a global pandemic and it's one of the main reasons they can evaluate the safety and effectiveness of the vaccine so rapidly
As for testing for long term effects, it isn't necessary for a vaccine that leaves your system in 72 hours. What remains is the antibodies, not the vaccine. Long term effects result from long term drug usage. Use smoking as an example - the risk of lung disease, etc comes from smoking cigarettes day-in, day-out for a long period of time. If you smoke a cigarette and then smoke a second cigarette a month later, you don't have to worry about contracting lung disease 50 years from now.
Worrying about long term side effects from a vaccine taken a few times over the span of months shows a fundamental lack of understanding of how medicine and our bodies work.
Why Cominarty and BionTech are likely not one and the same
Again, BioNTech is a company, not a drug. Beyond that, that link shows a fundamental misunderstanding of the vaccines being developed as well as how the clinical trials have progressed (which, again, is all contained within the links I posted). Multiple versions of the BNT162 mRNA vaccine were developed. BNT162b1 encodes a trimerized, secreted version of the SARS-CoV-2 spike glycoprotein, whereas BNT162b2, encodes a prefusion stabilized, full-length SARS-CoV-2 spike protein. The version carried into Phase III trials was BNT162b2, which involved ~44,000 participants. This is what is now known as Comirnaty. The link you posted on this is an absolute joke. There is no secret there were multiple versions of BNT162; no, clinical trial data was not cherry-picked; and the appropriate regulatory requirements and thresholds were met for full approval of BNT162b2 (aka, Comirnaty).
For those keeping track, I've produced at least 10 links to truthful, factual, and VERIFIABLE information proving what a lying imbecile BEG is
Well, when those links include vaccine development steps that were met, clearly false statements from so called experts who later admit they were wrong, and clearly flawed and biased arguments coming from joke sources like "Silview Media" and random posters on "Clouthub" it doesn't really help your case.
I would love to hear your credentials.
Aside from "Flat-Earther"
Aside from "Flat-Earther"
Seeing some of the sources he cites and links he posts, this makes a lot of sense.
Taking offers, will consider trades for moose or brown bear hunt. I know what I've got, low balls will be ignored. Beef or liver flavor.