Pfizer "90% Effective" Doesn't Mean It's Effective

haidut

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The FDA authorized the use of this drug for the Hoax. Read it and weep THEY ARE INSANE!!!!! this gives an idea of how desperate they are to show the world how wonderful the Big Pharma is, The answer to all our medical problems

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product
bamlanivimab

https://www.fda.gov/media/143603/download

Yep, and that's after the trial was already halted for safety reasons. So, basically they are saying "the drug is probably not safe enough to pass though the regular approval process, but guess what - we have this amazing trick called EUA, and we will use it to give this drug to people". Oh and btw, WITHOUT informing the hapless patients that the drug was never actually approved, because under EUA and the state of emergency we are under, most rules about informed consent do not apply.
Eli Lilly's Trial For COVID-19 Antibody Treatment Halted For Safety Reasons
 

tankasnowgod

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wouldnt you make more than that just working for 6 months???
do you have any other numbers? really interesting.

Well, the same friend now works for one of the big tech companies and makes more than that in a single month, but he didn't at the time. He was making around $10 an hour or so. On the face of it, it does seem like a big payday at that level (get paid $17,000 or so for doing nothing but lie in bed? Sign me up!), but as soon as you hear the details, I would think most interest goes away quick.
 

Max23

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Hah! I check in now and again on an old normy circular I used to frequent.
There's a lot of nice older people on it. Some doctors.
Anyway, one of the nice doctors posted this today:

"The vaccine is pure genius. It is, in effect, messenger RNA. After it gets injected, it enters the cells and “makes them” produce an antigen - which is a protein identical to the one in the spikes of Coronavirus. Our immune mechanisms notice that protein - and produce antibodies to it. Voila! That’s immunity. Once the real CoViD virus shows up, those antibodies bind to the viral spike proteins - and the game is up. The virus is neutralized.

So, rather than use millions of eggs to grow a weakened “real” virus, or the antigenic parts of it - our own cells do all the manufacturing.

A."

And all the non doctors said 'thanks for the explanation A. So, it's great news.'

What might be a good article to send to Anatole? He really is a nice man and very smart. He's capable of understanding but probably never looks outside standard practice.

About this vaccine I keep thinking, why would the organism make antibodies to something itself makes. It sounds so sci-fi. Why is it going to make antibodies to this protein and not to any other it manufactures? Also what is the homeostasis. How much protein does the cell make? What makes the cell stop creating those antigens? How will the organism differentiate between foreign and domestic antigens in the future? Why do you need to vaccinate every year, if the cells have been taught or turned into vaccine manufacturing units as Bill Gates said?
 

Ignoramus

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Because this thing is being moralised so much, would a possible loophole be to claim that one has 'religious' reasons for not taking the vacc? If one claimed that they were Islamic or something then it would look bad from the dominant leftist perspective to force the vaccine and vitiate any 'marginalised' religious rights, right?
 

boris

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Why is it going to make antibodies to this protein and not to any other it manufactures?

Because it's toxic. The vaccine will make you produce those spikes you see around retroviruses. The spikes are responsible for deactivating a part of our immune system and creating an entryway for the pathogen. Making your own cells create these is a truly demented concept.

RP: "The problem is that our bodies can copy foreign RNA and DNA and incorporate the copies into our chromosomes. If they are genes for viral proteins, it’s possible that during a future stress, those foreign genes could be expressed throughout our body, creating overwhelming amounts of those toxic proteins. The copies could be inserted into sperm cells and eggs as well as body cells, forming part of future generations. No sane person would consider doing it, if they understood how our cells respond to alien nucleic acids."
 
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pepsi

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blob69

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Here is CHD take on it: Pfizer Vaccine 90% Effective Claim Unsubstantiated by Peer-Review Journals and World Health Organization • Children's Health Defense

I think results of such studies could be totally made up for all we know. These companies operate like criminals and profits from this are huge.

"It won’t have escaped you that the airwaves are currently booming with news from an interim report of the Phase 3 trial on the Pfizer-BioNTech mRNA-based vaccine, snappily named BNT162b2. It’s one of 48 vaccines under clinical evaluation that aims to protect against COVID-19. The primary source of the news, headlined by a “90% effective” claim, isn’t a peer reviewed journal article. Nor is it the World Health Organization (WHO). Rather, it’s a media release issued on Monday by Pfizer, the commercial partner linked to the young German biotech company BioNTech, that developed the vaccine.

The news that the vaccine has been shown to be “90% effective” has sent Pfizer stocks flying, and caused the company’s recently appointed, ex-veterinarian chairman, Dr Albert Bourla, to sell off 62% of his personal stock in Pfizer. The share sale was apparently tripped by an automated system set up in August when the share value hit a given price."

"Alas, while the WHO page was updated yesterday, the report isn’t there. What you will find there is the now outdated trial design for the vaccine as a link to the NIH ClinicalTrials.gov portal. But no interim study results. A Google search using the terms ‘“Data Monitoring Committee” BNT162b2 BioNTech Pfizer’ and similar didn’t make it magically appear either, just lots of references to the “90% effectiveness” claim across a plethora of media channels. Suffice to say, I think we can confirm that there are no supporting data for the claim."
 

achillea

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After months of objections, the National Institutes of Health (NIH) and Moderna have capitulated and provided ICAN a copy of their internal 322-page Safety Summary Report and now over 700 pages of the Appendices to that report, for the Phase I trial of their COVID-19 vaccine (mRNA-1273). A full copy of this report and its appendices is available below and this is the first time it is being made available to the public.
We shared a few weeks ago that ICAN received the first 332 of over 1,000 pages of Moderna’s safety data from its Phase I trial, which it stated in its press release was “positive interim clinical data” that “substantiate[d] [their] belief that mRNA-1273 has the potential to prevent COVID-19 disease.”
ICAN has now received the complete report which contains an additional 714 pages of Appendices. It can be downloaded here. ICAN and its subscribers are the first people in the world, outside of NIH and Moderna, to actually see this data. Like last time, we will be carefully studying all of the disclosed data but ICAN wanted to widely disseminate it immediately so that others have the opportunity to do the same.
This report and its appendices were produced to ICAN in response to ICAN’s original FOIA request, and resulting litigation, for: “All safety and efficacy data and information regarding mRNA-1273, including from the Phase I clinical trial of this experimental vaccine conducted by the National Institute of Allergy and Infectious Diseases.”
What ICAN has received provides important information for the public to know in evaluating Moderna’s vaccine, which just this week was claimed to be 94.5% effective. The Appendices contain, among other things, a breakdown of all local and systemic adverse events and categorize them as mild, moderate, and severe.
ICAN’s legal team are still seeking additional documents responsive to its original request as this report and its appendices do not address efficacy (only safety) despite Moderna’s initial press release comments about efficacy. ICAN will also challenge some of the redactions made within the document.

https://www.icandecide.org/wp-content/uploads/2020/11/Moderna-Combined-Production.pdf
 

lampofred

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The vaccine will make you produce those spikes you see around retroviruses. The spikes are responsible for deactivating a part of our immune system and creating an entryway for the pathogen. Making your own cells create these is a truly demented concept.

So it shuts down the immune system?
 

Giraffe

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Covid-19 vaccine candidate is unimpressive: NNTV is around 256 | The BMJ

Dear Editor

Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant?

We already know that current Covid-19 vaccine trials are unlikely to show a reduction in severe illness or deaths. (Doshi, BMJ 2020;371:m4037, October 21) Will they be like seasonal influenza vaccines, which have not proved to be lifesavers, and may even have increased overall mortality in the elderly? (Anderson et al, Ann Intern Med 2020;172:445) We need a lot more time and a lot more data, especially in view of massive uncertainties about Covid-19 case definitions and statistics.

ALLAN S. CUNNINGHAM 13 November 2020

Competing interests: No competing interests

13 November 2020
Allan S. Cunningham
Retired pediatrician
 

tankasnowgod

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There is not much data available online but here is this link.
Pfizer’s COVID-19 Vaccine 90 Percent Effective: Initial Data
"...While it’s unclear exactly how many of the trial’s 43,000 participants, who received either two doses of the vaccine or the placebo, have contracted COVID-19, the interim analysis includes 94 confirmed cases. Among these 94, roughly 10 percent had been given the vaccine, while the other 90 percent had been given a placebo."

So, first of all, 94 out of 43,000 patients represents just 0.2% infection rate. These 94 cases were roughly split into 90% / 10% for placebo/vaccine groups. I would like to see the analysis that determined that such a small number is actually a statistically significant result, especially when it is further split between the placebo and vaccine groups. Also, I would like to see how the vaccine and placebo groups have been selected and controlled for lifestyle choices. Are all people whom the vaccine protected from an urban setting with strong mask and social distancing mandates? Are all cases in the placebo group from areas with lax requirements - i.e. rural/conservative areas in the US? That alone could easily explain the difference in infection rates. There are so many opportunities for shenanigans here and unfortunately. I don't think the full report/analysis on which the vaccine would be approved is likely to ever be released. Only Pfizer, FDA and the CRO conducting the trial have access to it and it is usually protected better than govt info classified at the top secret level. Oh, btw often even FDA does not get to see the full analysis/report due to "trade secrets" info such reports allegedly contain.
And last, but not least, all these trials are testing is infection prevention. They do not test for any of the important measures such as whether the vaccine prevents/reduces exacerbations, hospitalizations, deaths, or even transmission of infection to another person.
COVID-19 Vaccine Trials Are Essentially Pointless

@Drareg

Anthony Colpo just published an article, citing a report by Peter Doshii, that the results of the trial might just be good old fashioned fraud. He focuses on a key anomaly in the study, people who were ejected from the study for no particular reason-


You'll note that a similar number of subjects were excluded from the study for not receiving all their vaccination/placebo shots - as one would expect in a randomized study.

But take a look at the figures for those excluded due to "other important protocol deviations," which I've highlighted. No specific reasons for exclusion are provided for the folks in this vague category, which makes it a great place for researchers to pull a Study 329-style swifty. Cominarty recipients who experienced negative outcomes could easily have been "excluded" from the study and slotted into this nebulous category, hence favourably skewing the final efficacy and safety analyses.

Lo and behold, we see 311 Cominarty subjects excluded from the study for unnamed "other important protocol deviations," but only 61 in the placebo group. No explanation, of course, is provided for this striking difference.

When Doshi pointed out this highly suspicious anomaly, his critics countered that the 371 mysteriously withdrawn subjects comprised "less than 1% of the study population and can therefore hardly have influenced the study outcome."

Rubbish.

These critics are conveniently forgetting that the total number of people diagnosed with COVID-19 in the study was also less than 1% of the total study population.

In fact, the 250-person difference between the drug and placebo groups dwarfed the total number of COVID cases recorded in the study. In a study with only 170 total COVID-19 diagnoses, and only 6 deaths, a 250-person difference in exclusions for no specific reason could have had a huge impact on the study's results.

Did Pfizer inappropriately exclude a significant number of positive COVID-19 cases, serious adverse effects and/or deaths among Cominarty subjects using the "other important protocol deviations" category?


We don't know, but given the company's long history of criminal dishonesty it's a possibility we simply cannot rule out.

The possibility of data-tampering is heightened by the fact that three Pfizer employees were tasked with the job of "reviewing all potential COVID-19 illness events."

With 250 more subjects ejects from the mRNA/Cominarty group than Placebo/Meningitis, it's easy to see how the whole "95% effective" rate could be cut down drastically, shrink to 0, or even go negative. If the extra 250 people ejected from the Cominarty group were positive COVID 19 cases, the Pfizer vaccine could have made trial participants 59% more likely to be diagnosed with COVID. Or, the vaccine is -59% effective! If all 311 were, the vaccine would increase chances of a COVID diagnosis by 91%, assuming there were no COVID positives in the 61 ejected in the placebo group.

Plenty of room for fraud to jack up (or completely invent) that 95% effective number.

You can see Doshii's chart here, and I have added a screenshot to this post- https://www.fda.gov/media/144245/download#page=18

Doshi Chart.png
 

Giraffe

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A new comment published in The Lancet compares NNV (= how many people need to be vaccinated to prevent 1 "case") vs. this bogues RRR (relative risk racio). The follwing picture is taken from that comment. Later in the text they mention that real live results differ from that of the Pfizer study: To prevent just one "case" even more people need to be vaccinated without getting any benefits.

1621113590749.png


The only reported indication of vaccine effectiveness is the Israeli mass vaccination campaign using the Pfizer–BioNTech product. Although the design and methodology are radically different from the randomised trial,2 Dagan and colleagues11 report an RRR of 94%, which is essentially the same as the RRR of the phase 3 trial (95%) but with an ARR of 0·46%, which translates into an NNV of 217 (when the ARR was 0·84% and the NNV was 119 in the phase 3 trial). This means in a real-life setting, 1·8 times more subjects might need to be vaccinated to prevent one more case of COVID-19 than predicted in the corresponding clinical trial.

Uncoordinated phase 3 trials do not satisfy public health requirements; platform trials designed to address public health relevant questions with a common protocol will allow decisions to be made, informed by common criteria and uniform assessment. These considerations on efficacy and effectiveness are based on studies measuring prevention of mild to moderate COVID-19 infection; they were not designed to conclude on prevention of hospitalisation, severe disease, or death, or on prevention of infection and transmission potential. Assessing the suitability of vaccines must consider all indicators, and involve safety, deployability, availability, and costs.

COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room
 
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