What is the placebo in these trials?
Don't know. I saw the James Corbett video that Danny Roddy posted, in which he claims the placebo is also a vaccine but I haven't seen anything confirming that.
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What is the placebo in these trials?
Don't know. I saw the James Corbett video that Danny Roddy posted, in which he claims the placebo is also a vaccine but I haven't seen anything confirming that.
Turns out it was a bump-and-dump: https://nypost.com/2020/11/11/pfizer-ceo-sold-5-5m-in-stock-amid-covid-19-vaccine-reveal/
Don't know. I saw the James Corbett video that Danny Roddy posted, in which he claims the placebo is also a vaccine but I haven't seen anything confirming that.
That is correct, and in general there are no true placebo trials for infectious diseases any more. All of them have some kind of vaccine for the control group due to "ethical reasons".
Another COVID-19 Treatment Trial Halted For Safety Reasons
@ecstatichamster
Turns out it was a bump-and-dump: https://nypost.com/2020/11/11/pfizer-ceo-sold-5-5m-in-stock-amid-covid-19-vaccine-reveal/
We have no idea if it will be effective or safe
According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. [...] Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. [...]
If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.
With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.
Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)
What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.
I have no intention of getting the vaccine but am still looking for ways to counteract the negative effects (for people who are forced to take it) by deactivating the vaccine and it’s carrier ingredients. The mRNA is encapsulated in a liposomal layer, and specifically a layer of PEGylated lipid nanoparticles. My initial idea was to add megadoses of pancreatic enzymes to digest the foreign protein, which may be somewhat effective, but before that we have to employ agents that will rapidly dissolve the lipid coating first.
Amazing, thanks so much! The 70% adverse event rate is VERY concerning, to say the least. Even cancer drugs rarely reach such a "milestone" and often get cancelled if they do.
WOWLetter from Frank Shallenberger, MD, HMD regarding the Covid 19 Vaccine
Dear Patients and Friends,
Last week I must have been asked 20 times about the new COVID vaccines. Here are my thoughts. Please pass this informatiion onto many as you can. People need to have fully informed consent when it comes to injecting foreign genetic material into their bodies.
1. The COVID vaccines are mRNA vaccines. mRNA vaccines are a completely new type of vaccine. No mRNA vaccine has ever been licensed for human use before. In essence, we have absolutely no idea what to expect from this vaccine. We have no idea if it will be effective or safe.
2. Traditional vaccine simply introduce pieces of a virus to stimulate an immune reaction. The new mRNA vaccine is completely different. It actually injects (transfects) molecules of synthetic genetic material from non-humans sources into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for. Note that these newly created proteins are not regulated by our own DNA, and are thus completely foreign to our cells. What they are fully capable of doing is unknown.
3. The mRNA molecule is vulnerable to destruction. So, in order to protect the fragile mRNA strands while they are being inserted into our DNA they are coated with PEGylated lipid nanoparticles. This coating hides the mRNA from our immune system which ordinarily would kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Because of their effect on immune system balance, several studies have shown them to induce allergies and autoimmune diseases. Additionally, PEGylated lipid nanoparticles have been shown to trigger their own immune reactions, and to cause damage to the liver.
4. These new vaccines are additionally contaminated with aluminum, mercury, and possibly formaldehyde. The manufacturers have not yet disclosed what other toxins they contain.
5. Since viruses mutate frequently, the chance of any vaccine working for more than a year is unlikely. That is why the flu vaccine changes every year. Last year’s vaccine is no more valuable than last year’s newspaper.
6. Absolutely no long term safety studies will have been done to ensure that any of these vaccines don’t cause the cancer, seizures, heart disease, allergies, and autoimmune diseases seen with other vaccines. If you ever wanted to be guinea pig for Big Pharma, now is your golden opportunity.
7. Many experts question whether the mRNA technology is ready for prime time. In November 2020, Dr. Peter Jay Hotez said of the new mRNA vaccines, "I worry about innovation at the expense of practicality because they [the mRNA vaccines] are weighted toward technology platforms that have never made it to licensure before." Dr. Hotez is Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine, where he is also Director of the Texas Children’s Hospital Center for Vaccine Development.
8. Michal Linial, PhD is a Professor of Biochemistry. Because of her research and forecasts on COVID-19, Dr. Linial has been widely quoted in the media. She recently stated, "I won't be taking it [the mRNA vaccine] immediately – probably not for at least the coming year. We have to wait and see whether it really works. We will have a safety profile for only a certain number of months, so if there is a long-term effect after two years, we cannot know."
9. In November 2020, The Washington Post reported on hesitancy among healthcare professionals in the United States to the mRNA vaccines, citing surveys which reported that: "some did not want to be in the first round, so they could wait and see if there are potential side effects", and that "doctors and nurses want more data before championing vaccines to end the pandemic".
10. Since the death rate from COVID resumed to the normal flu death rate way back in early September, the pandemic has been over since then. Therefore, at this point in time no vaccine is needed. The current scare tactics regarding "escalating cases" is based on a PCR test that because it exceeds 34 amplifications has a 100% false positive rate unless it is performed between the 3rd and 5th day after the first day of symptoms. It is therefor 100% inaccurate in people with no symptoms. This is well established in the scientific literature.
11. The other reason you don’t need a vaccine for COVID-19 is that substantial herd immunity has already taken place in the United States. This is the primary reason for the end of the pandemic.
12. Unfortunately, you cannot completely trust what you hear from the media. They have consistently got it wrong for the past year. Since they are all supported by Big Pharma and the other entities selling the COVID vaccines, they are not going to be fully forthcoming when it comes to mRNA vaccines. Every statement I have made here is fully backed by published scientific references.
13. I would be very interested to see verification that Bill and Melinda Gates with their entire family including grandchildren, Joe Biden and President Trump and their entire families, and Anthony Fauci and his entire family all get the vaccine.
14. Anyone who after reading all this still wants to get injected with the mRNA vaccine, should at the very least have their blood checked for COVID-19 antibodies. There is no need for a vaccine in persons already naturally immunized.
Here's my bottom line: I would much rather get a COVID infection than get a COVID vaccine. That would be safer and more effective. I have had a number of COVID positive flu cases this year. Some were old and had health concerns. Every single one has done really well with natural therapies including ozone therapy and IV vitamin C.. Just because modern medicine has no effective treatment for viral infections, doesn’t men that there isn’t one.
Yours Always,
Frank Shallenberger, MD, HMD
I have no intention of getting the vaccine but am still looking for ways to counteract the negative effects (for people who are forced to take it) by deactivating the vaccine and it’s carrier ingredients. The mRNA is encapsulated in a liposomal layer, and specifically a layer of PEGylated lipid nanoparticles. My initial idea was to add megadoses of pancreatic enzymes to digest the foreign protein, which may be somewhat effective, but before that we have to employ agents that will rapidly dissolve the lipid coating first.
Liposomes and Lipid Nanoparticles as Delivery Vehicles for Personalized Medicine
Liposomes and lipid nanoparticles (LNPs) have emerged as one of the most effective drug delivery vehicles for new therapies, providing valuable advancements in terms of disease targeting.www.exeleadbiopharma.com
Letter from Frank Shallenberger, MD, HMD regarding the Covid 19 Vaccine
Peter Doshi now outlined "new concerns about the trustworthiness and meaningfulness of the reported efficacy results." He writes that we need the raw data to address open questions.
Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data
Peter Doshi also raised concerns about an unofficial unblinding and a surprisingly high rate of reinfections in those vaccinated.
Do you care to explain which of Doshi's arguments you don't agree with and why?I've just found this post that counters Doshi's arguments. Are you familiar with it?
This is also a graph from the FDA document that states cumulative difference between two groups of COVID-19 occurence after the first dose. I didn't go through all of the document, but supposedly it includes all participants.
Does anyone have a sensible interpretation on how to read this?
View attachment 23450
Ok, sorry. I've read his blogpost a while ago and found his argument regarding excluding the participants (of which there is no mention in the NEJM) pretty convincing. I checked and saw in the FDA document that they in fact excluded for "other deviations" 5 times more subjects in the vaccinated group than a placebo around or before the second dose. I took it as granted, that they probably had adverse reactions and that this way they hid some complications after the shot. I took it as a strong point that undermines their efficacy claim, since by adding those numbers to either groups would produce a diametrically opposite picture.Do you care to explain which of Doshi's arguments you don't agree with and why?
And as the writer says, the "suspected Covid cases" were not actual cases, but reports from people about the symptoms. After those reports they were supposedly tested for Covid, but not positively, as I understand.
The plot in the picture above that I posted is showing "all-available efficacy", of which I know little conceptually (from what I read it includes all subject on a time scale after the first shot). This "all-available efficacy" is being contrasted to the "evaluable efficacy", which is what the NEJM study is showing. But both are in favor of the vaccinated group in relation to their definition of covid illness.
I am wondering how is it, that after including all participants into the plot, there's still much more "COVID-19 occurences" in the placebo group? What could be the cause for this difference?
After thinking about it, I am somewhat reluctant to think that Pfizer would make a slip in their own data, the reports and briefings had to be scrutinized thoroughly before letting it out, they have resources to review it and they probably could not afford a possible mistake for people to hook on. That's a speculation from me. At this point my best guess is that they were using some prewired tests, but it's a claim without any basis.