Embedded Files
https://www.stopworldcontrol.com/downloads/en/vaccines/vaccinereport.pdf The Vaccine Death Report contains a tremendous amount of critical information, that you will find nowhere else in such a comprehensive and well organized format. It ends with a strong message of hope, that will greatly empower you. This report is a critical alarm call to the world. Download it now, and distribute it far and wide.
An experienced doctor speaks frankly About a week ago a medical practitioner from New York, Dr Vladimir Zelenko, testified before the rabbinical court in Jerusalem about Covid and the Covid vaccine. He has extensive experience in the treatment of Covid patients in his New York practice – all of whom recovered using his protocol – and a deep familiarity with the side effects of the vaccine. He told the court that the side effects, which are potentially fatal, fall into three broad categories: (1) acute cases involving cardiac and other problems caused by clotting and inflammation, as well as an eight-fold increase in miscarriages during the first trimester; (2) sub-acute cases where the immune system later attacks itself when presented with a live version of the virus against which it has been vaccinated (known as antibody dependent enhancement or pathogenic priming); and (3) longer term cases where the vaccine causes sterility, cancer, and a range of serious autoimmune diseases.
Poison death shot [Speaking about the plan to vaccinate children, who are virtually immune from Covid, he said:] “So, if you have a demographic that has no risk of dying from an illness, why would you inject them with a poison death shot?”
15 Spike protein factory “According to the Salk Institute, when a person gets the Covid vaccine, the body becomes a spike-producing factory, making trillions of spikes [i.e. spike proteins] that migrate to the endothelium, which is the lining of your blood vessels. Basically [these act like] little thorns on the inside of your vasculature. As the blood cells flow through it, they could be damaged [by the spikes], causing blood clots.” The CDC is corrupting VAERS data “I have colleagues that lost patients to the vaccine. They try to file reports. The VAER system rejects their reports for no reason. And another problem, and I have evidence for this as well, that reports that were filed are now being scrubbed off the system and you can't even find them.”
Israeli government is doing the work of Josef Mengele [He stated that the Covid vaccination rate in Israel, at 85 percent, is the highest in the world.] “The Pfizer CEO said, ‘Israel is the biggest laboratory in the world.’ And so those long-term human studies to rule out pathogenic priming have not been done...In my opinion, the current Israeli government is a ghoul of Josef Mengele. They have permitted human experimentation of their own people... I have received death threats, daily death threats. I have risked my life, my career, my financial life, my reputation, my family, everything just to sit here and tell you what I'm doing.” This is World War Three “...if we follow the advice of some of the quote-unquote, global leaders, let's say, like Bill Gates who said last year, “Seven billion people need to be vaccinated.” If that happens, the death rate will be over two billion people. So, wake up! This is World War Three! This is a level of malfeasance and malevolence that we have not seen, probably in the history of humanity...There is zero justification, zero justification for using this poison death trap unless you want to sacrifice human beings.”
www.wadeburleson.org /2021/08/dr-zelenko-speaks-to-jerusalem.html
Dr. Zelenko Speaks to Jerusalem Rabbinical Court
22-28 minutes
Whether or not you agree with Dr. Zelenko, it's worth your time to hear this week's presentation to the Jersualem Court. As Dr. Zlenko states, "Noah was a conspiracy theorist until it started raining." For the dogmatic who state, "Dr. Zelenko is crazy! What he says is lunacy!" I say, "Maybe. It's not yet raining. We'll see." In the end, trust God. ___________________________________________________________________________________________________________________________________________________________________
Dr. Vladimir Zelenko is a board-certified family physician for over twenty years. He has been described by his patients as a family member to thousands of families and is a medical adviser to the volunteer ambulance corps in Kiryas Joel, New York. Dr. Zelenko developed his now famous “Zelenko Protocol,” which has saved countless lives worldwide. So welcome, Dr. Zelenko. Thank you for joining us. And I would like you to comment on our subject, please.
Dr. Zelenko: Thank you so much for having me. Can you hear me?
Panel: Yes, loud, and clear. Very clear.
Dr. Zelenko: So, I'll just give you quickly my experience. My team has directly treated successfully 6,000 patients. I have trained hundreds of physicians who are now training their students. And as a cumulative group, we've treated millions of patients successfully. President Trump was my patient. Rudy Giuliani was my patient. Rev Chaim Kanievsky has been my patient. Mr. Nitzan Horowitz, your health minister of Israel, last year was my patient. I'm just telling you which people have contacted me for care and including President Bolsonaro of Brazil.
Now, my experience has given me a very unique perspective in approaching COVID-19, which is basically keeping people out of the hospital. I would like to describe…regarding children, the only reason you would want to treat a child is if you believe in child sacrifice (can’t understand what he’s saying) like a carbon of a very good reason to give the child. Otherwise, there's no necessity.
Let me explain. Any time you evaluate any therapeutic, you need to look at it from three perspectives.
1. Is it safe?
2. Does it work?
3. And do you need it?
Just because you have a capability doesn't mean that you have to use it. There has to be a medical necessity. There has to be a need for it.
Look at the CDC, the statistics for children under the age of 18 that are healthy, the survival rate is 99.998 percent survival rate with no treatment. Just like Dr. Uden said, the influenza virus is more dangerous to children than COVID-19. And he made an estimate that per million, one hundred children would die from the vaccination. I feel the number would be significantly higher and I'll explain to you the rationale for it.
So, if you have a demographic that has no risk of dying from an illness, why would you inject them with a poison death shot?
Now, let's see if this thing works. The two countries in the world that have the most vaccinated citizen are Eretz Israel (The Land of Israel) – an 85% rate of vaccination, and an island nation in the Indian Ocean, called Seychelles, also over 80% rate of vaccination. Both countries are experiencing a Delta variant outbreak.
So let me ask you a question. If you vaccinated…if you vaccinated the majority of your population, why are you still having an outbreak? That's number one. Number two, why would you even give a third shot of the same stuff that didn't work the first two times? That's whether or not it works.
And let's talk about safety. Now, this is the real issue. There are three levels of safety or death that we need to look at.
1 Acute
2. Subacute,
3 Long term.
Acute is defined from the moment of injection until three months. The number one risk of the shot is blood clots, just like Yudin, according to the Salk Institute.
By the way, everything I'm saying, I will defend with documentation, and please don't take my word for it. You should do your due diligence. And I can provide to you proof of everything that I'm saying.
According to the Salk Institute, when a person can get an injection of these things, the body becomes a spike-producing factory, making trillions of spikes that migrate to the endothelium, which is the lining of your blood vessels and has basically little thorns on the inside of your vasculature. As the blood cells flow through it, they could damage and cause blood clots.
If that happens in the heart, it's a heart attack. If it happens in the brain, it’s a stroke. So, we're seeing the number one cause of death in the short term is from blood clots. And most of it is happening within the first three or four days. 40% of blood clot cases are happening within the first three days of infection of this poison death shot.
Now, the second (acute) problem is that it's causing myocarditis or inflammation in the hearts of young adults.
And the third (acute) problem is the most disturbing is, according to the New England Journal of Medicine article, their preliminary data, the miscarriage rate in the first trimester. A woman gets vaccinated in the first trimester goes from 10% to 80%. I want you to understand what I just said. The miscarriage rate in the first trimester of pregnant women when they get vaccinated goes up by a factor of eight. That's preliminary data. It may change with time, but I'm just telling you what it is as of today. That's the smallest of the problem.
The second category is the subacute death issue. The animal studies that were done with these vaccines show that all the animals responded well generating antibodies. But when they were challenged, however, with the virus that they were immunized against, a large percentage of them died. And when that was investigated, it was found that their immune system had killed them. It's called antibody-dependent enhancement or pathogenic priming or paradoxical immune enhancement. But the point is that a lot of those animals died.
So, you can make an argument maybe human beings are different. My answer to you maybe, however, those studies (human studies) were not done. You are the study right now. The Pfizer CEO said, “Israel is the biggest laboratory in the world.” And so those long-term human studies to rule out pathogenic priming have not been done.
Luc Montagnier, who won the Nobel Prize in medicine for the discovery of HIV, said that this is the biggest risk to humanity and the biggest risk of genocide in the history of humanity. And so, the risk of an ADE (antibody-dependent enhancement) in human beings, which happens later, has not been ruled out. So my question is, why would I vaccinate someone with a potentially destructive lethal substance without ruling that out first?
And the third component here is the long-term consequences. There is definite evidence that it affects fertility, damages ovarian function that reduces sperm counts. Number one definitely increases the amount of auto-immune diseases. Who knows over time how that is going to reduce life span? And just last week, a paper came out showing that it increases the risk of cancer.
So, anyway that you want to look at it:
1. Whether in an acute setting where it causes blood clots, inflammation of the heart, and miscarriages, or,
2. In the midterm subacute setting, where it can result in a pathological disastrous immune reaction, or
3. In the long term whether it causes autoimmune diseases, cancer, and infertility.
Now that's a big concern.
Actually, I will say it this way: In my opinion, the current Israeli government is guilty of doing what Josef Mengele did. They have permitted human experimentation of their own people. And I'm going to tell you, I hope, I hope this is a little different. Maybe not.
If you see trouble in the Jewish people, you should look at the rabbinic leadership. If the head is diseased, what do you expect of the body? So, I beg of this debate to put the interests of the people of Israel above politics and anything else that may alter your opinions,
I have I received death threats, daily death threats. I have risked my life, my career, my financial life, my reputation, my family, everything just to sit here and tell you what I'm doing.
So, I'll just summarize
There is no need for this vaccine.
There's actually no need for any to get it. Children are already told they have a 99.998 percent chance of getting better. Young adults from 18 to 45 have a 99.95 percent. It's getting better just according to the CDC. Same concept.
Someone who has already had COVID that has antibodies, naturally induced immunity, has a billion times more effective immunity than artificially induced immunity through vaccine. So why? Why would I vaccinate someone with a poison death shot that makes inferior or dangerous antibodies when I already have healthy antibodies?
And then if you look at the high-risk population (the elderly) that has a 7.5 percent death rate. So, my data, which was the first one in the world which I published in a peer-reviewed journal, which has become the basis of over two hundred other studies, and I have corroborated my observations that if you treat people in the right time frame, you reduce death rate by 85 percent.
So out of 600,000 Americans who died, we could have prevented 510,000 from going to the hospital and dying. And by the way, I presented this information to Benjamin Netanyahu directly into his hands in April of 2010, and I informed every single member of your Ministry of Health as well.
So, my question to you is, if I can reduce the death rate from 7.5 percent to less than a half a percent, why would I use a poison death shot that doesn't work and has tremendous and horrific side effects.
Let me do one more mind experiment with you, if everyone on the planet were to get COVID and not get treated, the death rate globally will be less than a half a percent. Now, I'm not advocating for that. That's a lot of people, that's thirty-five million people who will die. However, if we follow the advice of some of the quote-unquote, global leaders, let's say, like Bill Gates who said last year, “Seven billion people need to be vaccinated.” If that happens, the death rate will be over two billion people. So, WAKE UP! This is World War Three! This is a level of malfeasance and malevolence that we have not seen, probably in the history of humanity.
I'm against child sacrifice. I am against idolatry. I really believe that God is testing every human being. And here's the test.
Are you going to bow down to Me? Are you going to ask for your protection from Me? Are you going to take your fears and ask Me to help, or are you going to run to the idol of the vaccine of your governments, of despots and tyrants like sociopaths who want to be deities?
There is nothing new under the sun. These people are no different than Pharoah. They think they're God. And you're going to bow down to them? If you're going about down them, listen, “Okay, let them protect you. Let's see how that's going to work out for you!”
I’m seeing fear drive people to do things that are completely irrational, things that do not make sense. They sacrifice their own children.
And yes, your Ministry of Health flying you your statistics are absolutely skewed.
Do you want to see something real? Go to the website World Meter.Info. Go to the nation of Israel and you can see it. On December 20, 2020, there's a huge spike in the curve of death in Israel. You know what happened in Israel, December 20th? National Immunization started. And these are numbers being reported by the Israeli government. They’re just too stupid just to hide it.
There is zero justification, zero justification for using this poison death trap unless you want to sacrifice human beings. I think I’m done.
Panel: After these words from Dr. Zelenko, I don't ever think you can say, “I’m done.”. We very much appreciate your time and effort. You are very definite and very clear.
Dr. Zelenko: Do you have any questions?
Panel: We have many questions. But just to summarize. Two billion would pass out (die) if seven billion people received the shot according to you’ve said, correct?
Dr. Zelenko: No, not according to what I said, according to what world experts are saying, that if you look at Dr. Malone, who invented the RNA technology as the original patents for the vaccine is saying, “Do not use this. The government is lying to you. The side effects are horrific.” Dr. Cahill from Ireland said that she believes within two years, 90 percent of the people that got vaccinated will be dead. When Dr. Michael, I hope you can confirm I hope he's still there to ask that question. He said you wouldn't go that far. So, I don't know, maybe it's not 90 percent or what is the percentage? Maybe it's not two years. Maybe it's three years. Yeah, and look at what Dr. Montagnier said. He is the Nobel Prize winner for the discovery of HIV, and said, “This is the biggest risk of genocide in the history of men.”
Panel: So just a bit, if you have six million that have received the vaccine in Israel? Correct? Do you have the number? No. Three million. So, three million. So if we take our percentage at 3,000,000, we should be seeing some 500000 or 800,000 die?
Dr. Zelenko. Over time.
Panel Member: Dr. Zelenka, you know, you mentioned studies that definitely - the studies that came out - that is definitely a cause fertility of problems, sperm count, and now recently a cancer research study that says that it the causes cancer. Where the government showed these? Why are they holding back this thing we see all the time coming out of studies? They say, “There's no problems at fertility – bluff; There’s no problems of sperm count – bluff. There’s no cancer – bluff. Everything you’ve said is being countered back not only by the governments but by most of the medical industry is telling us that all these studies the vaccination is dangerous is all baloney and promoted by anti-vax crazies.
Dr. Zelenko: I can answer that. For every single person you just mentioned, if you sum total the number of patients they've treated for Covid, it all equals zero. And I've treated over 6,000 patients. So you have to know who you're talking about.
Now, what I'm going to tell you is the following, yes, there's been a very coordinated effort to suppress lifesaving information, drugs like Hydroxychloroquine, Chloroquine, and Ivermectin, which are the safest medications in the history of medicine, have been suppressed. And you can't even get them in Israel.
Doctors who dare to say something that is against the narrative are being de-platformed. This includes world experts like Dr. Malone, for example, who developed the mRNA vaccine. He said something against the narrative and was de-platformed from every media platform. Can you tell me why?
And then can you tell me why there is suppression of knowledge of side effects about this poison death shot? And then tell me why there's this incredible coercion, psychological pressure, and now using force to compel people to take the shot? You should be answering that question, not me. There is a coordinated effort here. And Israel is leading the way.
Panel: It appears that the United States is also not showing the numbers that you’re saying either?
Dr. Zelenko: Now you started. There's data that shows as of today eleven thousand dead people and four hundred and fifty thousand adverse events (in the United States). First of all, is that not enough? What's your threshold of death?
Panel: No, just one (death).
Dr. Zelenko: . OK, VAERS is already admitting to that there's a CDC whistleblower that just said it's not 11,000, but it's 45,000. That's not enough. And then there's a 2009 Harvard study that said that only one percent of actual events (vaccination injuries) are reported. Now, I can make an argument that perhaps that a rash is reported at a much lower rate than death. So, for the benefit of the doubt, let's say, let's say 20 percent of deaths are being reported and I'm being very generous. So, if you take 45,000, according to the whistleblower, or even if you take a 11,000 to what they admit, so the number is either 50,000 or 200,000 – you choose.
And then there are two other problems with VAERS. I have colleagues that lost patients to the vaccine. They try to file reports. The VAER system rejects their reports for no reason. And another problem, and I have evidence for this as well, that reports that were filed are now being scrubbed off the system and you can't even find them.
By the way, this is not a conspiracy theory. It's a conspiracy; not a theory. Eighteen months ago, if I would have told you the COVID-19 is a bioweapon, you would say that I'm a conspiracy theorist. Noah in the Bible was a conspiracy theorist until it rained.
So right now, if I tell you that this is an artificially made bioweapon, it's a conspiracy, not a theory. Everyone agrees now that this disease was artificially made.
And I even I know exactly when it was made and I know the numbers associated with the modifications. In 1999 Dr. Ralph Barrett at the The University of North Carolina modified a bat coronavirus and on a surface protein in order that it should infect human beings. Then that research became illegal in America. It got sent by the American taxpayer dollars and by Fauci to WUHAN where that research continued and until they figured out a way to modify this virus, to make it extremely more destructive to human lungs and to cause blood clots.
So, they took an artificial, naturally occurring virus and slowly made two changes to it over time. It took them 20 years to modify it so that it should infect humans and then when it does infect humans, that it should destroy a tissue. Now, no one's saying I'm a conspiracy theorist. People are saying that it’s a conspiracy. It's a conspiracy to commit genocide.
Is it so hard for Jewish people to believe that there could be a group of people willing to destroy? It's a war against God.
There are two ways of looking at life. Either you look at a human being as made in the image of God. If you are made in the image of God, that means your life has sanctity. IF your life has sanctity, then you have human rights. And if you have human rights then it is not your or my business to decide how many people should be on the planet and who should live or die. Right?
The other system, the Darwin eugenics system, says “Who is on top of the dominance hierarchy of life? Those that have the biggest survival benefit. That inevitably leads to three categories of
people:
1. The ubermensch.
2. The mench
3. The untermensch
If you apply that 80 years ago, the ubermensch were these Nazis who were the defender of the Aryan gods who felt it was in their prerogative, their right to decide who lives or dies. So the mench were the Anglo-Saxon, the Europeans could live and be slaves. And the untermenschen, the Jews, the Slavs, handicap, gypsies, political prisoners, those who had to become dust.
Sounds like a fairy tale? Except that killed two hundred million people.
It's the same exact thing now, except that it's not anti-Semitic right now. It's completely different. There's a group of people that feel that they've evolved into a higher level of consciousness than their new intelligence and insight allows them to determine these things. I don't think they evolved. I think they're devout pagans. There's no difference from that.
Panelist: I understand that, but let's … listen, the CDC itself is also, and Mr. Biden, is also running a vaccination program. I'm saying I'm against the program, but, you know, you can scream over here but the people in America, there are 200 million people in America who took the vaccine.
Dr. Zelenko: Let me tell you about the CDC. President Trump made an executive order that every single American should have access to Hydroxychloroquine. That order went to Health and Human Services Secretary Geithner and that eventually ended up at the CDC by Dr. Rick Bright. And then what Dr. Rick Bright did, instead of using the right to try legislation that would have made access this medication to every American and every human being around the world. The biggest complaint I got from Israel was, “Well, your CDC and your FDA are not approving it.” Because especially the Israeli government is a puppet to whatever the Americans do.
So, because the Americans weren't willing to do it, Israel wasn't willing to do it. And so what did they do? They created an executive use authorization that restricted and limited access to only hospitalized patients, effectively cutting it off from patients in an outpatient setting at home.
This has been documented by Dr. Rick Bright himself in a documentary called Totally Under Control. These are not my words; those are his words.
And furthermore, then they took away the emergency use authorization for hydroxychloroquine, and they used the Lancet Study that showed that hydroxychloroquine kills people. The problem with that study was that it was a fraud and they had to retract that study because it was based on data that didn't exist.
But the FDA and the CDC used that study after it was retracted to revoke the emergency use authorization (of hydroxychloroquine). And the reason why is that if that drug has an emergency authorization, other drugs can’t! And three weeks later Remdesivir, made by Gilead Pharmaceuticals, received an emergency use authorization, a three-billion-dollar contract. And Remdesivir showed no survival benefit. It reduced hospital stay by five days but with no survival benefit. It cost $3,200 a patient and IV. The drugs that I was using cost 20 cents a pill at home and reduced death and hospitalization by 84 percent. That means they reduce the market share and for Remdesivir disappear by 84 percent.
So, the CDC is not an authority to me. You know, according to the NIH right now, you're not supposed to treat COVID unless you're in the hospital and your oxygen is less than 92 percent. Now, this is the advice and recommendation of a government that wants you to die. After 18 months and dozens of studies that have shown an 85 percent on the average benefit of avoiding hospitalization and death, and you have a government agency still making that recommendation.
They have completely lost all credibility. Yes, our governments are corrupt. Yes, our governments have conspired.
You know, if I was organizing this, I would come to a world leader. I would come to BB or or Bennett and say, “Listen, okay, here's five hundred million dollars. I will put it in an account you'll never know. Untraced, just listen to us. And if you don't, we're going to kill your family.”
Long Pause
Panel: Okay.
Dr. Zelenko: By the way, if you look at the Exodus… only one out of 10 Jews left Egypt and made it to Israel. What that means is, only 10 percent of our people are capable of making the psychological transition from slavery to redemptive thinking.
That's what the problem is here. It's a collision of two systems that cannot coexist, a God-centered consciousness versus idolatry. There is nothing new under the sun. It's all the same thing. It’s just that the battlefield now is Covid-19.
Panel: Okay, thank you very much, Dr. I want to thank you personally because I used your protocol myself and I was able to get the protocol.
Dr. Zelenko: I’m glad you got better. I just hope that every other Jew could be like you.
Panel: I know. I second that. I was like you, in the same boat word. Thank you, Doctor.
Dr. Zelenko:
You're welcome. But it's not about me. It's about the people. Why can't every other Jew in Eretz Israel (the land of Israel) have the same treatment?
tony martinsaid: https://cuttingthroughthefog.com/2018/11/09/current-events-discussion-thread/comment-page-113/#comment-144168
The Amish practically have no Autoimmune disorders.
They have almost no allergies. They never get sick from colds or flu.
It’s very very rare for these people to ever get sick. None of them take meds of any kind and it’s against their religion to get vaccinated.
They not only never get sick but they seem to be obviously much smarter than most people just judging their cognitive skills.
Even their 80+ year old great-grandparents are sharper than most of today’s 25 year old’s.
l think it is their lifestyle and anti-medical establishment views that keep them in such good health.
But now that we have public schools that mandate all children to be fully vaccinated it is VERY CLEAR that these vaccines are not good.
Autism is sky rocketing! Bipolar Disorder, Type-2 Diabetes, Mesothelioma, Crohns disease, IBS, Psoriasis, MS, RA, and Lupus are all seeing a dramatic increase in percentages of people that have one or more of these diseases.
It all usually starts with the MMR vaccine.
Over the last 3 decades they keep churning out more vaccines and mandating you get all of them. You can see the end result in today’s school-aged kids. Half of them have food allergies so bad that they can’t even eat normal foods.
They will probly forever be dependent on Big Pharma for survival.
Jared Magnesonsaid:August 15, 2021 at 6:23 am https://cuttingthroughthefog.com/2018/11/09/current-events-discussion-thread/comment-page-114/#comment-144487
Tom, it is the same with all mainstream religions. I grew up Mormon (of all things). I have studied every religion around, my entire life. They are all the same, they all pull the same tricks to make you feel good or bad about your choices and there isn’t one shred of logic to be found in any of them, because they are all the same Judaic Phoenician scams under various disguises.
But while your journey is your own, it is now over. A new religion has spawned by the same fucking assholes, only it’s the COVID religion. It’s exactly like all the others only it demands a baptism in fake mRNA and compels a belief in the CDC/WHO priesthood. And it has superceded all other religions. They are now defunct and irrelevant, so I am not here to talk about them because they actually don’t matter anymore. All of them have buckled under the weight of this new one, except the Amish which aren’t exactly a religion at all, and they remain relatively unscathed. But that’s another story.
Suffice it to say, as THEY say, all religions are now over and for once it’s clear which one is the Enemy. So I won’t bash the stupidity and blatant mind-numbing retardation of Mormonism, Catholicism, or your own Scientism (you can’t call it an “ology” if nothing is ever studied, sorry) because those don’t actually matter anymore. Either you’re pro-Covid or you are fucking awake. They’ve made it really simple for us ON PURPOSE, so they can weed us out as a “fringe group”. It’s quite effective but fuck them anyway.
If my diction seems scathing, that’s because it is. The time for weak words and soft tenor is over. It doesn’t actually matter WHAT you believe outside of this paradigm, you see. If you believe in truth, wholesome action and intent, and benevolence then your core childhood religion doesn’t matter in the light of the darkness of the Covid Death Cult. If you believe in coercion, support Tyranny and COMPULSION, then you are an evil person. I don’t think YOU are at this point, but this is where I feel like we are at right now.
Fortunately they have made it very simple.
https://www.globalresearch.ca/no-vaxx-rebellion-resist-refuse-reject/5746766?pdf=5746766
Without careful monitoring, cases of ADE or similar immune pathology caused by the vaccine would be indistinguishable from severe Covid-19.” (“How the vaccine can make Covid worse“, Conservative Woman)
Did you catch that last part about: “cases of ADE or similar immune pathology caused by the vaccine would be indistinguishable from severe Covid-19”?
This is the (evil) genius of the Covid vaccine, that is, when people start dying, their deaths are going to be blamed on Covid “variants” rather than the vaccine.
Why?
Because the symptoms are nearly identical.
As a recent study by the Salk Institute showed, Covid is primarily a vascular disease. In other words, it is the action that takes place in the bloodstream (inflammation, ADE, blood clots and bleeding) that kills people, not the respiratory virus. Unfortunately, the substance from the vaccines enters cells in the lining of the blood vessels producing spike proteins that are similar the spike proteins generated by Covid. The spike proteins attract platelets that cause blood clots, or they lead to bleeding (after the platelets are used up) or they create waste that is attacked by killer lymphocytes which damages blood vessels and organs. Bleeding, blood clots or auto immune disease; any of these conditions are possible following vaccination, perhaps, even | 8 probable.
https://newswithviews.com/father-the-rebellion-has-begun/
Vaccine disaster
Here are the latest numbers. Deaths: 4,863. Adverse reactions: 227,805 Permanently disabled: 2,719 Trips to the ER: 29,708
Hospitalizations: 12,625. Lagging reporting on these since April 16, 2021: 834 Anaphylaxis (completely under reported I covered before), 942 Bell’s Palsy, 1,132 Heart Attacks, 213 Miscarriages, 7,463 Severe Allergic Reactions, 822 Thrombocytopenia/Low Platlet
Deaths April 16: 3,486. As of May 30: 4,863, an increase of 1,377 dead Americans
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Silver Spring, MD 20993 w ww.fda.gov
Page 2 – STN BL 125742/0 – Elisa Harkins
You may label your product with the proprietary name, COMIRNATY, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.
We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.
DATING PERIOD
The dating period for COVID-19 Vaccine, mRNA shall be 9 months from the date of manufacture when stored between -90ºC to -60ºC (-130ºF to -76ºF). The date of manufacture shall be no later than the date of final sterile filtration of the formulated drug product (at (b) (4) , the date
of manufacture is defined as the date of sterile filtration for the final drug product; at
Pfizer (b) (4)
, it is defined as the date of the (b) (4)
Following the final sterile filtration, (b) (4)
, no
reprocessing/reworking is allowed without prior approval from the Agency. The dating
period for your drug substance shall be (b) (4) when stored at (b) (4)
We have
approved the stability protocols in your license application for the purpose of extending
the expiration dating period of your drug substance and drug product under 21 CFR
601.12.
FDA LOT RELEASE
Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).
BIOLOGICAL PRODUCT DEVIATIONS
You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, including those associated with processing, testing, packaging, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA 3486 to the Director, Office of Compliance and Biologics Quality, electronically through the eBPDR web application or at the address below. Links for the instructions on completing the electronic form (eBPDR) may be found on
CBER's web site at https://www.fda.gov/vaccines-blood-biologics/report-problem-center- biologics-evaluation-research/biological-product-deviations:
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
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10903 New Hampshire Ave. WO71-G112
Silver Spring, MD 20993-0002
MANUFACTURING CHANGES
You must submit information to your BLA for our review and written approval under 21
CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities.
LABELING
We hereby approve the draft content of labeling including Package Insert, submitted under amendment 74, dated August 21, 2021, and the draft carton and container labels submitted under amendment 63, dated August 19, 2021.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, please submit the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL)
format via the FDA automated drug registration and listing system, (eLIST) as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ default.htm. Content of labeling must be identical to the Package Insert submitted on August 21, 2021. Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND CONTAINER LABELS
Please electronically submit final printed carton and container labels identical to the carton and container labels submitted on August 19, 2021, according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications at https://www.fda.gov/regulatory-information/search-fda-guidance- documents/providing-regulatory-submissions-electronic-format-certain-human- pharmaceutical-product-applications.
All final labeling should be submitted as Product Correspondence to this BLA STN BL
125742 at the time of use and include implementation information on Form FDA 356h.
ADVERTISING AND PROMOTIONAL LABELING
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You may submit two draft copies of the proposed introductory advertising and promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling Branch at the following address:
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave. WO71-G112
Silver Spring, MD 20993-0002
You must submit copies of your final advertising and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR
601.12(f)(4)).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
ADVERSE EVENT REPORTING
You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports at monthly intervals as described in 21 CFR
600.81. For information on adverse experience reporting, please refer to the guidance for industry Providing Submissions in Electronic Format —Postmarketing Safety Reports for Vaccines at https://www.fda.gov/regulatory-information/search-fda- guidance-documents/providing-submissions-electronic-format-postmarketing-safety- reports-vaccines. For information on distribution reporting, please refer to the guidance for industry Electronic Submission of Lot Distribution Reports at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation
/Post-MarketActivities/LotReleases/ucm061966.htm.
PEDIATRIC REQUIREMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We are deferring submission of your pediatric studies for ages younger than 16 years for this application because this product is ready for approval for use in individuals 16 years of age and older, and the pediatric studies for younger ages have not been completed.
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Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study Requirement/Commitments” and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below:
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age. Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023
2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age. Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of
COMIRNATY in infants <6 months of age. Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024
Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.
Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to be considered fulfilled, you must submit and receive approval of an efficacy or a labeling
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supplement. For administrative purposes, all submissions related to these required pediatric postmarketing studies must be clearly designated as:
• Required Pediatric Assessment(s)
We note that you have fulfilled the pediatric study requirement for ages 16 through 17 years for this application.
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study
Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
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Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021
Progress Report Submission: September 30, 2021
Interim Report 1 Submission: March 31, 2022
Interim Report 2 Submission: September 30, 2022
Interim Report 3 Submission: March 31, 2023
Interim Report 4 Submission: September 30, 2023
Interim Report 5 Submission: March 31, 2024
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration
with Pediatric Heart Network).
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: December 31, 2026
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Final Report Submission: May 31, 2027
8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: June 30, 2022
Final Report Submission: December 31, 2022
Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number
as shown in this letter.
Please submit final study reports to the BLA. If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement to this BLA STN BL 125742. For administrative purposes, all submissions
related to these postmarketing studies required under section 505(o) must be submitted to this BLA and be clearly designated as:
• Required Postmarketing Correspondence under Section 505(o)
• Required Postmarketing Final Report under Section 505(o)
• Supplement contains Required Postmarketing Final Report under Section
505(o)
Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section. This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise
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undertaken to investigate a safety issue. In addition, section 506B of the FDCA and 21
CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials.
You must describe the status in an annual report on postmarketing studies for this product. Label your annual report as an Annual Status Report of Postmarketing Requirements/Commitments and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:
• the sequential number for each study as shown in this letter;
• information to identify and describe the postmarketing requirement;
• the original milestone schedule for the requirement;
• the revised milestone schedule for the requirement, if appropriate;
• the current status of the requirement (i.e., pending, ongoing, delayed, terminated, or submitted); and,
• an explanation of the status for the study or clinical trial. The explanation should include how the study is progressing in reference to the original projected schedule, including, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
We will consider the submission of your annual report under section 506B of the FDCA
and 21 CFR 601.70 to satisfy the periodic reporting requirement under section
505(o)(3)(E)(ii) provided that you include the elements listed in section 505(o) and 21
CFR 601.70. We remind you that to comply with section 505(o), your annual report must also include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Failure to periodically report on the status of studies or clinical trials required under section 505(o) may be a violation of FDCA section 505(o)(3)(E)(ii) and could result in regulatory action.
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS UNDER SECTION 506B
We acknowledge your written commitments as described in your letter of
August 21, 2021 as outlined below:
10.Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”
Final Protocol Submission: July 1, 2021
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Study Completion: June 30, 2025
Final Report Submission: December 31, 2025
11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age.
Final Protocol Submission: September 30, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
12.Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”
Final Protocol Submission: January 29, 2021
Study Completion: June 30, 2023
Final Report Submission: December 31, 2023
13.Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine
Effectiveness Study - Kaiser Permanente Southern California.”
Final Protocol Submission: March 22, 2021
Study Completion: December 31, 2022
Final Report Submission: June 30, 2023
Please submit clinical protocols to your IND 19736, and a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMC sequential number for each study/clinical trial and the submission number as shown in this letter.
If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement. Please use the following designators to prominently label all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
• Postmarketing Commitment – Correspondence Study Update
• Postmarketing Commitment – Final Study Report
• Supplement contains Postmarketing Commitment – Final Study Report
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For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. Label your annual report as an Annual Status Report of Postmarketing Requirements/Commitments and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:
• the sequential number for each study as shown in this letter;
• information to identify and describe the postmarketing commitment;
• the original schedule for the commitment;
• the status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted); and,
• an explanation of the status including, for clinical studies, the patient accrual rate
(i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
POST APPROVAL FEEDBACK MEETING
New biological products qualify for a post approval feedback meeting. Such meetings are used to discuss the quality of the application and to evaluate the communication process during drug development and marketing application review. The purpose is to learn from successful aspects of the review process and to identify areas that could benefit from improvement. If you would like to have such a meeting with us, please contact the Regulatory Project Manager for this application.
Sincerely,
Mary A. Malarkey Marion F. Gruber, PhD Director Director
Office of Compliance Office of Vaccines
and Biologics Quality Research and Review Center for Biologics Center for Biologics Evaluation and Research Evaluation and Research
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