"Pfizer withdraws application for Covid-19 vaccine emergency use in India after regulator requests more data
The Economic Times newspaper cited a government source saying that Pfizer wanted a clinical trial waiver for its vaccine, developed jointly with the German firm BioNTech, but the regulator has insisted on a bridging study in India. The experts wanted to see how the vaccine would work among the Indian population before it could be cleared for general use in the country, the source explained."
https://www.rt.com/news/514667-pfizer-india-vaccine-application/
The Economic Times newspaper cited a government source saying that Pfizer wanted a clinical trial waiver for its vaccine, developed jointly with the German firm BioNTech, but the regulator has insisted on a bridging study in India. The experts wanted to see how the vaccine would work among the Indian population before it could be cleared for general use in the country, the source explained."
https://www.rt.com/news/514667-pfizer-india-vaccine-application/
RT
Pfizer withdraws application for Covid-19 vaccine emergency use in India after regulator requests more data
Pfizer says it has withdrawn a request to have its Covid-19 vaccine authorized for use in India. The company has promised to resubmit the application once it gathers more data.
"Can the unvaccinated get sick from contact with the vaccinated?
The vaccine produces many trillions of particles of spike proteins in the recipient. Patients who are vaccinated can shed some of these (spike protein) particles to close contacts. The particles have the ability to create inflammation and disease in these contacts. In other words, the spike proteins are pathogenic (“disease causing”) just like the full virus. What is most worrisome is that a person’s body is being suddenly flooded with 13 trillion of these particles and the spike proteins bind more tightly than the fully intact virus. Because of the biomimicry (similarity) on the spike, shedding appears to be causing wide variety of autoimmune disease (where the body attacks its own tissue) in some persons. Worldwide cases of pericarditis, shingles, pneumonia, blood clots in the extremities and brain, Bell’s Palsy, vaginal bleeding and miscarriages have been reported in persons who are near persons who have been vaccinated. In addition, we know the spike proteins can cross the blood brain barrier, unlike traditional vaccines."
https://www.americasfrontlinedoctors.org/action-alerts/identifying-post-vaccination-complications-their-causes-an-analysis-of-covid-19-patient-data
The vaccine produces many trillions of particles of spike proteins in the recipient. Patients who are vaccinated can shed some of these (spike protein) particles to close contacts. The particles have the ability to create inflammation and disease in these contacts. In other words, the spike proteins are pathogenic (“disease causing”) just like the full virus. What is most worrisome is that a person’s body is being suddenly flooded with 13 trillion of these particles and the spike proteins bind more tightly than the fully intact virus. Because of the biomimicry (similarity) on the spike, shedding appears to be causing wide variety of autoimmune disease (where the body attacks its own tissue) in some persons. Worldwide cases of pericarditis, shingles, pneumonia, blood clots in the extremities and brain, Bell’s Palsy, vaginal bleeding and miscarriages have been reported in persons who are near persons who have been vaccinated. In addition, we know the spike proteins can cross the blood brain barrier, unlike traditional vaccines."
https://www.americasfrontlinedoctors.org/action-alerts/identifying-post-vaccination-complications-their-causes-an-analysis-of-covid-19-patient-data
👍3
"India’s homegrown Covid-19 vaccine Covaxin was approved for emergency use back in January without any Phase III data. That data has now been published but in the meantime, the vaccine has been shrouded in controversy.
People’s College said it had put a system in place to follow up with patients every day for seven days following administration of the first dose. However, this data collection has been described as “extremely chaotic” and many of the trial participants claimed they were not contacted each day, and some not at all, meaning that the data around any adverse events from this site may have been tainted.
Additionally, some patients that felt ill after receiving the vaccine went back to the hospital for treatment and were asked to pay or were turned away.
To make matters worse, in December there was one case of death in a patient who had received the vaccine in the Phase III trials, although Bharat affirmed this was not down to its vaccine but in fact due to some unspecified poison the patient had consumed. Critics have argued that this certainty was completely unwarranted, especially as the patient’s family had a very different version of events, stating that the patient became ill soon after receiving the vaccine."
https://www.clinicaltrialsarena.com/analysis/covaxin-indias-homegrown-covid-19-vaccine-brings-hope-and-controversy/
People’s College said it had put a system in place to follow up with patients every day for seven days following administration of the first dose. However, this data collection has been described as “extremely chaotic” and many of the trial participants claimed they were not contacted each day, and some not at all, meaning that the data around any adverse events from this site may have been tainted.
Additionally, some patients that felt ill after receiving the vaccine went back to the hospital for treatment and were asked to pay or were turned away.
To make matters worse, in December there was one case of death in a patient who had received the vaccine in the Phase III trials, although Bharat affirmed this was not down to its vaccine but in fact due to some unspecified poison the patient had consumed. Critics have argued that this certainty was completely unwarranted, especially as the patient’s family had a very different version of events, stating that the patient became ill soon after receiving the vaccine."
https://www.clinicaltrialsarena.com/analysis/covaxin-indias-homegrown-covid-19-vaccine-brings-hope-and-controversy/
Clinical Trials Arena
Covaxin: India’s homegrown Covid-19 vaccine brings hope and controversy
Bharat biotech has finally released Phase III data for its Covid vaccine, Covaxin. But can the controversial candidate get India out of its dire situation?
Forwarded from Deleted Account
Im not an expert and I could be off here but I have a related question that maybe Michael Yeadon or someone could address in some fashion. One thing I haven't been able to find info on is the duration that the modified RNA will be active for in a vaxxed person. From my basic understanding of cells is that DNA creates RNA and if no changes in the DNA take place as mainstream scientists claim with the mRNA based gene therapy drugs, then the modified RNA in cells will eventually be replaced by the cells original version of RNA that had previously been created purely from the person's DNA. However, I know the cell replication varies widely between cell types from days to months and I have no idea which cells are affected or how to estimate which cells can shed the artifically created spike protein and hence any way to estimate the time period where caution may be waranted?
Forwarded from Mike Yeadon
Rise,
It’s a great question & one I was asked today by RJK Jr.
The surprising answer appears to be that nobody knows.
Normally, with an entirely new drug class, which this definitely is, even if it’s also classified as a “vaccine”, it’d be necessary to study drug disposition (where does it go and how is it transformed & eliminated?) as well as pharmacodynamics (what does it do & for how long?).
But because the sneaky bastards managed to get these novel, gene based agents, classified as vaccines, they followed the regulatory path of requirements set out for a vaccine.
Under the vaccine development guidelines, the innovator isn’t required to study any of those things.
So when people get churlish about whether the name of the product category matters, well, yes it does!
There are strictly essential things which have not been done & aren’t going to be done.
Not happy.
Cheers
Mike
It’s a great question & one I was asked today by RJK Jr.
The surprising answer appears to be that nobody knows.
Normally, with an entirely new drug class, which this definitely is, even if it’s also classified as a “vaccine”, it’d be necessary to study drug disposition (where does it go and how is it transformed & eliminated?) as well as pharmacodynamics (what does it do & for how long?).
But because the sneaky bastards managed to get these novel, gene based agents, classified as vaccines, they followed the regulatory path of requirements set out for a vaccine.
Under the vaccine development guidelines, the innovator isn’t required to study any of those things.
So when people get churlish about whether the name of the product category matters, well, yes it does!
There are strictly essential things which have not been done & aren’t going to be done.
Not happy.
Cheers
Mike
Forwarded from Deleted Account
Pfizer seem to think that shedding (transmission of spike proteins) is a potential risk:
pp67-68
https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf#page67
pp67-68
https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf#page67
Forwarded from Eshani King
We are now talking of an entirely different form of shedding. Previously that only happened with live attenuated ( theoretically) virus where whole virus was being shed and would be potentially capable of infecting someone else. But now we talking about shedding of the spike protein only. Whilst that is not infectious, it can cause pathology on its own. In fact, it is probably the main part that causes all the nasty pathology in CoVID itself. The jabs are causing the body to produce as many or more spike particles than the disease itself would have done - depending on the person.
"This T cell-mediated immune response is even more important as studies on humoral immunity to SARS-CoV-1 provided evidence that antibody responses are short-lived and can even cause or aggravate virus-associated lung pathology"
https://pubmed.ncbi.nlm.nih.gov/32999467/
"Note that when you get the shot the first thing you get is antibodies; you may get a T-cell reaction. This pre-existing knowledge, from SARS (CoV-1) entirely explains why people who just got vaccinated often get hammered by the virus and frequently end up in the hospital or die. It marks the premise of attempting to vaccinate out of a pandemic where transmission is actively occurring as stupid.
You go get the shot. Five days later you get the virus. You have not yet developed immunity and the partial expression makes it worse.
You would have been better off, by far, taking the same infection straight up front. It likely would have harmed you less.
This generally applies, by the way, to all vaccines and all viruses. The government and researchers know this. They've known this for decades. It's fact. It's why you don't wait until the measles is raging around you to get a measles vaccine and the same is true for the flu shot; you get it before the flu season starts for this very reason. Attempting to vaccinate out of a raging infection does not work and in fact kills people.
Yeah, if you don't get infected during that latent period you get protection. But if you do get infected you're screwed and all of the two-dose shots have a roughly four week window during which you get hosed instead of protected. Israel's data, by the way, proves this is real; Berenson has been reporting on it since the beginning of the year and I've noted it as well.
If you remember I've also pointed out that multiple studies have shown that somewhere between 30-50% of the population is T-cell reactive to Covid-19 despite never having had it, nor SARS or MERS, its alleged "precursors." But those studies were non-specific; that is, they looked for T-cell reactivity but never tried to identify the specific protein sequences and their part of the whole that was involved. This study does, and it finally puts light on basically the entire reason that what we've done is not only wrong it's criminally stupid."
https://market-ticker.org/akcs-www?post=242205
https://pubmed.ncbi.nlm.nih.gov/32999467/
"Note that when you get the shot the first thing you get is antibodies; you may get a T-cell reaction. This pre-existing knowledge, from SARS (CoV-1) entirely explains why people who just got vaccinated often get hammered by the virus and frequently end up in the hospital or die. It marks the premise of attempting to vaccinate out of a pandemic where transmission is actively occurring as stupid.
You go get the shot. Five days later you get the virus. You have not yet developed immunity and the partial expression makes it worse.
You would have been better off, by far, taking the same infection straight up front. It likely would have harmed you less.
This generally applies, by the way, to all vaccines and all viruses. The government and researchers know this. They've known this for decades. It's fact. It's why you don't wait until the measles is raging around you to get a measles vaccine and the same is true for the flu shot; you get it before the flu season starts for this very reason. Attempting to vaccinate out of a raging infection does not work and in fact kills people.
Yeah, if you don't get infected during that latent period you get protection. But if you do get infected you're screwed and all of the two-dose shots have a roughly four week window during which you get hosed instead of protected. Israel's data, by the way, proves this is real; Berenson has been reporting on it since the beginning of the year and I've noted it as well.
If you remember I've also pointed out that multiple studies have shown that somewhere between 30-50% of the population is T-cell reactive to Covid-19 despite never having had it, nor SARS or MERS, its alleged "precursors." But those studies were non-specific; that is, they looked for T-cell reactivity but never tried to identify the specific protein sequences and their part of the whole that was involved. This study does, and it finally puts light on basically the entire reason that what we've done is not only wrong it's criminally stupid."
https://market-ticker.org/akcs-www?post=242205
PubMed
SARS-CoV-2-derived peptides define heterologous and COVID-19-induced T cell recognition - PubMed
T cell immunity is central for the control of viral infections. To characterize T cell immunity, but also for the development of vaccines, identification of exact viral T cell epitopes is fundamental. Here we identify and characterize multiple dominant and…
"Let me be clear: The entire premise of all of the "mitigations" and demand for mass-vaccination relied on a lie; that this was a "novel" virus to which nobody had existing resistance. We now know that's false; 81% of the population in fact does have existing immunity and further, that immunity is strengthened, materially so, by natural infection. In short if you have said partial resistance you want to get the disease as the odds of you being seriously harmed are statistically zero yet you will perfect your immunity and from a public health perspective you want those people who are not going to be seriously harmed to get it naturally, not take a **ned shot because it is that perfection of immunity that stops the disease from being of harm to the public on a durable basis.
It gets worse -- the resistance isn't to the spike, it's almost-exclusively to the nucleocapsid portion of the virus among those with existing resistance; the largest set of reactions by far was to the nucleocapsid, not the spike. This is very strong evidence that it is that nucleocapsid reactivity that provides effective resistance to serious disease. The existing "vaccines" do not and cannot provide this since they encode only the spike.
Again for those who are reading-comprehension challenged: The existing vaccines are worthless for building said perfected immunity since the data is that the nucleocapsid section, which the vaccines do not code, is where most of the pre-existing resistance against serious disease resides."
https://market-ticker.org/akcs-www?post=242205
It gets worse -- the resistance isn't to the spike, it's almost-exclusively to the nucleocapsid portion of the virus among those with existing resistance; the largest set of reactions by far was to the nucleocapsid, not the spike. This is very strong evidence that it is that nucleocapsid reactivity that provides effective resistance to serious disease. The existing "vaccines" do not and cannot provide this since they encode only the spike.
Again for those who are reading-comprehension challenged: The existing vaccines are worthless for building said perfected immunity since the data is that the nucleocapsid section, which the vaccines do not code, is where most of the pre-existing resistance against serious disease resides."
https://market-ticker.org/akcs-www?post=242205
The Market Ticker
Science Catches Up -- And Burns You All
<p>There is a reason science is a <em>process </em>and until you understand something you should keep your ******ned mouth shut.</p><p>Especially when all you have against 40+ years of hard science
"Further this paper points out that induction of immunity against the spike may well be worthless or even harmful. Again "prevention of infection" is meaningless if it is bypassed and you get hammered, as has repeatedly occurred during the window following vaccination. Indeed, such might even enhance the progress of infection and mortality and if that's not enough insult there's reason to believe the same enhanced risk may also present itself on the "back end" as antibodies to the spike wane too with no way to know when that window occurs in a specific individual.
It is quite clear from this study that recognition of the nucleocapsid proteins is the difference between asymptomatic or mild infections and severe ones; the correlation is exact and yet exactly zero of the existing vaccines target anything other than the spike. You cannot build immunity to that which is not presented. With the spike now having evidence of direct pathology and in fact quite possibly being why serious organ damage and death occur with natural infection we have clearly gone down the wrong road with "warp speed" and in fact may have done irrevocable and severe harm to millions of Americans while failing to induce long-term nucleocapsid immune recognition which occurs via natural infection and is the key to turning a potential infection into a nuisance at worst.
Short-term prevention of "infection" among the 81% of those with existing T-cell recognition to the nucleocapsid proteins is not only stupid it is likely to kill people over the intermediate and longer term since those who are not vaccinated and get infected with partial resistance build additional and durable immunity via said low-symptom and asymptomatic infections which do not materially harm them and blocking that process is harmful, not helpful.
This group includes nearly all young adults and children for which people are trying to force vaccination."
https://market-ticker.org/akcs-www?post=242205
It is quite clear from this study that recognition of the nucleocapsid proteins is the difference between asymptomatic or mild infections and severe ones; the correlation is exact and yet exactly zero of the existing vaccines target anything other than the spike. You cannot build immunity to that which is not presented. With the spike now having evidence of direct pathology and in fact quite possibly being why serious organ damage and death occur with natural infection we have clearly gone down the wrong road with "warp speed" and in fact may have done irrevocable and severe harm to millions of Americans while failing to induce long-term nucleocapsid immune recognition which occurs via natural infection and is the key to turning a potential infection into a nuisance at worst.
Short-term prevention of "infection" among the 81% of those with existing T-cell recognition to the nucleocapsid proteins is not only stupid it is likely to kill people over the intermediate and longer term since those who are not vaccinated and get infected with partial resistance build additional and durable immunity via said low-symptom and asymptomatic infections which do not materially harm them and blocking that process is harmful, not helpful.
This group includes nearly all young adults and children for which people are trying to force vaccination."
https://market-ticker.org/akcs-www?post=242205
The Market Ticker
Science Catches Up -- And Burns You All
<p>There is a reason science is a <em>process </em>and until you understand something you should keep your ******ned mouth shut.</p><p>Especially when all you have against 40+ years of hard science
"Our findings show that the SARS-CoV2 spike protein causes lung injury even without the presence of intact virus," said Pavel Solopov, Ph.D., DVM, research assistant professor at the Frank Reidy Research Center for Bioelectrics at Old Dominion University. "This previously unknown mechanism could cause symptoms before substantial viral replication occurs."
https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html
https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html
Medicalxpress
SARS-CoV-2 spike protein alone may cause lung damage
Using a newly developed mouse model of acute lung injury, researchers found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms including severe inflammation ...
Forwarded from Howard Steen
It is worth listening to Dr. Vanessa Schmidt Krüger who gave evidence to the Corona Committee about the Pfizer vaccine. In theory there should not be a problem with the m-RNA technology. She explains how practice has deviated from the theory. The clinical trials which were made used a laboratory produced product made on a small scale process which manufactured m-RNA to the needed high degree of purity. But this process was not a financially viable option for scaling up to mass production. The large scale process has some serious flaws and is producing the m-RNA at sometimes only around 55% of the desired purity. She claims the commercial product contains amounts of linearised DNA which should be broken down but is not. There is a high chance that liner DNA can get into the human cell and alter the genetic code. Here is the evidence from Schmidt Krüger:
https://odysee.com/@shortXXvids:e/Frau-Dr.-Vanessa-Schmidt-Kru%CC%88ger--CA-37-Vaccine:f
Discussion about contamination starts at around 8 minutes into the video.
I produced the subtitles for this and the translation was was done by a professionally qualified translator. I was a chemical engineer by profession so I can fully relate to the processing scale up issues that were discussed in this session. This process being used for mass production is not the same process use for making the product for the clinical trials.
https://odysee.com/@shortXXvids:e/Frau-Dr.-Vanessa-Schmidt-Kru%CC%88ger--CA-37-Vaccine:f
Discussion about contamination starts at around 8 minutes into the video.
I produced the subtitles for this and the translation was was done by a professionally qualified translator. I was a chemical engineer by profession so I can fully relate to the processing scale up issues that were discussed in this session. This process being used for mass production is not the same process use for making the product for the clinical trials.
Odysee
Problems with European mRNA Vaccine Authorisation explained by Cell Biology Expert - Part I
German Language video with English subtitles
On Jan 29th 2021, The Cell Biology expert, Dr. Vanessa Schmidt-Krüger, gave evidence at the 37th sitting of the German Corona Committee concerning the manu...
On Jan 29th 2021, The Cell Biology expert, Dr. Vanessa Schmidt-Krüger, gave evidence at the 37th sitting of the German Corona Committee concerning the manu...
I said a long time ago that the vaccines should have targeted at least the N protein if not all 29 SARSCoV2 proteins (through stimulating T-cells in the patient) not the S protein alone. That this was a massive mistake. I said it on my twitter account and shared the science on N proteins and coronavirus replication immunity. That account has been permanently suspended. The official reason given was that N protein vaccines enhance ADE. I think that is possible but that does not mean that S protein vaccines do not. I think we have the worst pathogenic vaccines possible and India is proving they increase cases and deaths. This is the definition of ADE: antibody dependent enhancement. This is what is happening in India, both in the 3 week window after vaccinations which is now extended to 6 weeks through 2 jabs. Then there is shedding in these 6 weeks causing further infections and further ADE on those vaccinated. An amplification mechanism is set in place. The question now is: is the mistake deliberate? So that a new generation of vaccines need to be produced? Covaxin uses the entire virus, Astrazeneca only the spike protein. Similar ADE & similar shedding?
"The existing vaccines are worthless for building said perfected immunity since the data is that the nucleocapsid section, which the vaccines do not code, is where most of the pre-existing resistance against serious disease resides."
https://market-ticker.org/akcs-www?post=242205
"The existing vaccines are worthless for building said perfected immunity since the data is that the nucleocapsid section, which the vaccines do not code, is where most of the pre-existing resistance against serious disease resides."
https://market-ticker.org/akcs-www?post=242205
The Market Ticker
Science Catches Up -- And Burns You All
<p>There is a reason science is a <em>process </em>and until you understand something you should keep your ******ned mouth shut.</p><p>Especially when all you have against 40+ years of hard science
#India needs to stop all vaccinations immediately and revert to the MONOTTI PROTOCOL
https://nulluslocussinegenio.com/2021/03/23/the-monotti-protocol/
https://nulluslocussinegenio.com/2021/03/23/the-monotti-protocol/
No Place Without Spirit
The Monotti Protocol For Keeping Society Open
The Monotti Protocol, 2021 The Monotti Protocol aims to be at the same time extremely simple yet extremely effective. It consists of three main epidemic or pandemic control approaches, to be implem…