Pfizer covid vaccine frenzy

[Maia Gabrial]

Have you seen the videos showing how ALL Lamestream medias are saying the same thing as if they're all reading from the same script? Looks like they're doing the same thing with the vaccine information. We've really got to be more careful now.

Here is Del Bigtree of HireWire telling you what they're not telling you about the vaccies. 90% safety doesn't mean that at all. I suspect that even President Trump is being mislead....

https://www.brighteon.com/852cad05-d8c0-4442-a9ce-bab2b494a6c4

This warp speed testing doesn't make me feel better.... Geez! Anybody else sensing the same thing?

[Ernie Nemeth]

The reason they do animal trials, by the way, which they skipped in this race to a vaccine, is to study long term adverse effects. This is because animals generally don't live as long as humans so a generational study can be fast tracked this way. Usually the animal trials go on for at least three years to be safe.

Without the animal testing, there is no way to know the long term health effects of the new mRNA vaccines which have never been used on humans before. And, so far, the animal testing done for other mRNA technologies has been a complete failure.

Do not get the mRNA vaccine. Stick to attenuated virus 'live' vaccines, if you have to be immunized. But the best is to contract the virus naturally, get over it in a day or two, and be immune naturally for life. There is almost no possibility of death if a healthy person contracts the virus anyway.

note: I have not watched Del's video yet, so these are my off the cuff comments. Actually, these are my talking points now with strangers I meet on the street.

[Metaphor]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

[Karen (Geophyz)]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

From what I understand, your response to the virus depends on your age and if you have any other health conditions. I do not think at this point you can say it is not a big deal. For many people it is!

[IChingUChing]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

Hi Metaphor,
can you tell me what the govt is planning there regarding vaccines and any other measures. Tomorrow in Germany they decide on implementing laws which could mean we decide to leave and possibly come to Sweden. Is there any suggestion of mandatory vaccines there or limitations on travel or access to culture or shops etc if you haven't been vaccinated?
Many thanks!

[Metaphor]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

From what I understand, your response to the virus depends on your age and if you have any other health conditions. I do not think at this point you can say it is not a big deal. For many people it is!
I get what you are saying, and as you point out depends on factors other than the virus itself. Wich, bottom line, is my point here.

[Metaphor]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

Hi Metaphor,
can you tell me what the govt is planning there regarding vaccines and any other measures. Tomorrow in Germany they decide on implementing laws which could mean we decide to leave and possibly come to Sweden. Is there any suggestion of mandatory vaccines there or limitations on travel or access to culture or shops etc if you haven't been vaccinated?
Many thanks!

No mandatory stuff at all at this point. Other than social preassure, that is. Could change of course.

You could also consider Denmark, that backed off from mandatory vaxx after 9 days of protests.

[IChingUChing]

Thanks Metaphor! That's what we're hoping for here too but somehow I doubt they will back down in Germany. I know our govt rep is going to vote in favour of the law although we tried to make him understand all the reasons against it. Let's see what happens tomorrow.

[onawah]

Pfizer Vaccine 90% Effective Claim Unsubstantiated by Peer-Review Journals and World Health Organization
11/16/20
By Rob Verkerk PhD
https://childrenshealthdefense.org/defender/pfizer-vaccine-claim-unsubstantiated-peer-review-journals-who/?utm_source=salsa&eType=EmailBlastContent&eId=85227058-d7bf-4222-89c9-d93879f6c617

"Can the public afford to trust vaccine companies who deliberately withhold information and data and have preyed on the public’s desperation to escape lockdowns, while, at the same time, reaping the rewards from the stock market that has responded to a premature and unsupported announcement?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.

Chasing rainbows

Pfizer was conspicuous, given its position as one of the largest drug companies in the world, in excluding itself from the U.S. government Operation Warp Speed. The downside for Pfizer was that it didn’t benefit from the U.S. government (= taxpayer) funding support that the likes of Moderna, Johnson & Johnson and Astra-Zeneca have been privy to. But don’t feel too bad, BioNTech received funding from the German government. The plus side for Pfizer was that it didn’t need to be dictated to by others, and it didn’t need to data share or have its data analysed by a shared, Operation Warp Speed data monitoring committee. Remember this as you read on.

So, what do the headlines really mean? Here’s the first problem. We only have a press release to go on. At ANH, we’re always keen to get to primary data sources so we had to look further. The press release refers to an interim report on the Phase 3 trial by an “external, independent Data Monitoring Committee (DMC)”. An article by the Kaiser Family Foundation suggests that Pfizer’s DMC is anything but independent. The anonymity of its 5 members also makes it anything but transparent.

We weren’t going to give up looking for the interim report given widespread calls, such as that in a September editorial in one of the world’s most influential journals, Nature, which argued “COVID vaccine confidence requires radical transparency”.

We’d seen the protocol, but if better-than-expected interim primary outcomes were going to be cited, we had to assume Pfizer or BioNTech would make the data behind the results available. The first place we went hunting for the interim report was the WHO “Draft landscape of COVID-19 candidate vaccines” page, that incidentally “disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents”.

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.

What we’ve been told

Back to the press release. The key pieces of information that fall out of it are as follows:

The claim in its full glory: “more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2.”
A link to an updated study design (protocol) which presumably replaces the one listed on ClinicalTrials.gov.
43,538 participants enrolled to-date (89% of which have received the second dose)
42% of participants have “ethnically diverse backgrounds” (which begs the question what ethnicity is the non-diverse 58%; surely not Caucasian? But probably.)
94 people out of the 43,538 participants (i.e. just 0.2%) have contracted COVID-19 so far, these being split between the vaccinated and placebo groups, the split not being reported.
“No serious safety concerns have been observed” — which does not mean moderate or severe adverse reactions have not been observed. Two months of safety data will be available at the time Pfizer applies for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA).
The clearest statements of all appear in the disclosure notice and commentary on forward-looking statements at the end of the release that appear to be directed at the stock market. They effectively abrogate Pfizer and BioNTech of any responsibility for performance of the final product, especially in relation to effectiveness, safety or supply. The lawyers are clearly being attentive to their clients given the world’s eyes are on them.
What can we make of this?

In terms of the key statement on effectiveness, let’s say that just 10% of the infected group of 94 were infected. If you round that up to 10 people, a 90% claim that would make it 9 out of 10 were able to prevent infection post-vaccination. Not a lot of people potentially — which is why Pfizer and BioNTech should have been clear about numbers because 60 is a lot different to 10. But, remember that the press release states “over 90%”? Dialling in the inner Sherlock Holmes, just 11 of the infected group also being vaccinated, with 10 of these exhibiting immunogenicity as per predetermined trial endpoints would do it (9 divided by 10 gives 90.9%).

But for this interim endpoint the protocol lists primary and secondary endpoints for effectiveness — principally the prevention of COVID-19 symptoms in those showing evidence of infection (by nucleic acid amplification tests [NAAT]), as well as secondary ones — the development of various serological (antibody) results such as neutralizing antibody titers, S1-binding IgG and/or RBD-binding IgG levels, N-binding antibody. But which ones and by how much? And for how long (too soon for that of course)?

What else would we need to know to understand better the BioNTech/Pfizer interim result? Key information that hasn’t yet been put into the public domain and could have accompanied the interim release includes:

The number of people in the vaccinated or placebo groups who were exposed to SARS-CoV-2.
The demography (age, gender, ethnicity, etc) of those who were infected and how many of these represent the most vulnerable groups i.e., the elderly or those with comorbidities.
On what particular outcome parameters was the effectiveness determined? Was it, for example, based on lack of COVID-19 disease symptoms combined with elevated antibody responses, and if so which ones?
How serious was the manifestation of COVID-19 disease in the equivalent vaccinated and placebo groups (i.e., similar ages, gender, ethnicity and underlying disease pattern)?
What is the composition of the placebo that is being delivered to 50% of the 44,000-strong study population? Does it include the lipid nanoparticle minus the mRNA that encodes for the full-length spike protein of SARS-CoV-2?
What was the response of the cell-mediated (T cell) side of the adaptive immune system (which are not included in the endpoints according to the trial protocol)? The October publication of the Phase 1 results in the New England Journal of Medicine indicated it was the sister vaccine, BNT162b1, that produced a strong T-cell response but this was dropped as the vaccine induced some serious adverse reactions.
What was the nature, severity and extent of adverse events to BNT162b2 reported until now in the Phase 3 trial?
How long will immunogenicity against SARS-CoV-2 persist in different people?
Unknowns

There are also many unknowns that may well remain unknowns. Top of my list would be these two:

The possibility that some of the NAAT-confirmed cases involve infection with other human coronaviruses and it is these non-SARS-CoV-2 viruses that have triggered the measured immunogenicity and the NAAT results are either false positives or the result of SARS-CoV-2 viral fragments.
The presence of non-replicable viral fragments of (‘dead’) SARS-CoV2 have triggered immunogenic reactions so infection could not anyway have occurred.
As transparent as a not-quite-black box

As so appropriately put by Peter Doshi, an associated editor of the BMJ and also associate professor of pharmaceutical health services at the University of Maryland School of Pharmacy, “The lack of data is very concerning … All we have right now is a headline by Pfizer.”

What shall we make of it?

I’ve taken you through my thoughts triggered by the press release. You can see it’s led to a number of dead ends and it’s raised more questions than it’s answered. But let me distil my views down to the following:

In my view, it’s misleading, far too premature and disingenuous for Pfizer to be telling the world that the trial has demonstrated 90% effectiveness so far because most people will assume that that means, regardless of age, health status, ethnicity or underlying conditions, if they get vaccinated with an emergency approved vaccine that has undergone just 2 months of safety evaluation, they will have only a 10% chance of getting seriously ill if they become infected — and it will be safe. There are insufficient data to support either outcome.
It’s difficult to judge the effectiveness claim against what your chances might be if you remain unvaccinated. But if you’re healthy and under 75-years-old, the chances of serious disease are very low, probably much less than 10% following infection. But accurate estimates still cannot be made because we continue to be blind to the number of people who have been infected, and therefore, also to the true rate of serious disease and mortality among those infected. What we are also aware of are big variations in estimates of the number who are likely asymptomatic (infected but without symptoms).
Nothing can be said about the risk of harms from vaccination with two doses of BNT162b2 such as triggering autoimmune conditions as the trials need to run their course and most of these kinds of problems are generally not picked up until years after the product is first marketed. And that’s assuming a normal 6-year development program. Two months of post-vaccination adverse event reporting just doesn’t cut it if you want a proper handle on safety.
If this vaccine fails to be effective a few months after its second doses has been administered, is there going to be a justification made for its mass roll-out, given the huge economic cost to society, the risk of harms, and the fact that healthy people seem to tolerate SARS-CoV-2 more than adequately? Remember, it was the alternate BioNTech vaccine, BNT162b1, that was found to enhance the T-cell response more, but had an unacceptable safety profile so was dropped.
Where is the risk-cost-benefit analysis by governments showing that rollout is both necessary and justified?
Disturbingly, this announcement, and the lack of data associated with the press release, demonstrates that Pfizer and BioNTech have an incapacity for real and meaningful transparency.
This leads to one central question: Can the public truly afford to trust vaccine companies who deliberately withhold information and data and have preyed on the public’s desperation to escape lockdowns, while, at the same time, reaping the rewards from the stock market that has responded to a premature and unsupported announcement?

Call me a conspiracy theorist, if you like, for asking this question."

Published with permission from Alliance for Natural Health International.

[Maia Gabrial]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

My concern is what will show up in a few months time. What kind of damage will happen? I don't trust this hurried testing business. What IS the hurry anyway?
And why should we trust anything we're being told? They lied to us from the beginning. If they see that no one is following their agendas, they just get their lamestream liars to ramp up the fear mongering.... Some ppl can be frightened easily.

Here's a scary thought. Fortunately, coronavirus was not as devastating as we've been led to believe. We all figured out that you can't catch a virus anyway because our bodies are filled with trillions of viruses to begin with. They've been saying that a "second wave" is coming soon. Warned us about it. I say they tipped their hand instead. Here's the scary part: NOW they'll add a deadly GERM or BACTERIA to it that WILL ACTUALLY devastate all of us. And then dress us down for daring to doubt what they've been saying....

A word of comfort: The evil (meaning the members of the deep state) was allowed to rear its head, so that it can be judged. There is a Divine Plan....

[Metaphor]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

My concern is what will show up in a few months time. What kind of damage will happen? I don't trust this hurried testing business. What IS the hurry anyway?
And why should we trust anything we're being told? They lied to us from the beginning. If they see that no one is following their agendas, they just get their lamestream liars to ramp up the fear mongering.... Some ppl can be frightened easily.

Here's a scary thought. Fortunately, coronavirus was not as devastating as we've been led to believe. We all figured out that you can't catch a virus anyway because our bodies are filled with trillions of viruses to begin with. They've been saying that a "second wave" is coming soon. Warned us about it. I say they tipped their hand instead. Here's the scary part: NOW they'll add a deadly GERM or BACTERIA to it that WILL ACTUALLY devastate all of us. And then dress us down for daring to doubt what they've been saying....

A word of comfort: The evil (meaning the members of the deep state) was allowed to rear its head, so that it can be judged. There is a Divine Plan....

Maia, you are reflecting mine, and probably other members, deepest fears.
Resistance is of course nesessary but if possible, DO GO UNDER THE RADAR, when the s*** hits the fan. Hopefully fake vaccine ID will be obtainable if it comes to that. Thats a last resort though.
Lets dream a better dream.

[rgray222]

This is alarming

How Ticketmaster Plans to Check Your Vaccine Status for Concerts: Exclusive

https://static.billboard.com/files/2020/08/audience-concert-crowd-billboard-1548-1597786154-compressed.jpg

Monday's news that pharmaceutical company Pfizer's early results on a new COVID-19 vaccine showed a 90% efficacy rate on an initial clinical trial have given concert professionals hope that the business can start mounting a return in 2021. As part of that preparation, Ticketmaster has been working on a framework for post-pandemic fan safety that uses smart phones to verify fans' vaccination status or whether they've tested negative for the coronavirus within a 24 to 72 hour window.

Many details of the plan, which is still in development phase, will rely on three separate components -- the Ticketmaster digital ticket app, third party health information companies like CLEAR Health Pass or IBM's Digital Health Pass and testing and vaccine distribution providers like Labcorp and the CVS Minute Clinic.

Here's how it would work, if approved: After purchasing a ticket for a concert, fans would need to verify that they have already been vaccinated (which would provide approximately one year of COVID-19 protection) or test negative for coronavirus approximately 24 to 72 hours prior to the concert. The length of coverage a test would provide would be governed by regional health authorities -- if attendees of a Friday night concert had to be tested 48 hours in advance, most could start the testing process the day before the event. If it was a 24-hour window, most people would likely be tested the same day of the event at a lab or a health clinic.

Once the test was complete, the fan would instruct the lab to deliver the results to their health pass company, like CLEAR or IBM. If the tests were negative, or the fan was vaccinated, the health pass company would verify the attendee's COVID-19 status to Ticketmaster, which would then issue the fan the credentials needed to access the event. If a fan tested positive or didn't take a test to verify their status, they would not be granted access to the event. There are still many details to work out, but the goal of the program is for fans to take care of vaccines and testing prior to the concert and not show up hoping to be tested onsite.

Ticketmaster would not store or have access to fans' medical records and would only receive verification of whether a fan is cleared to attend an event on a given date. Different states will have different requirements. The main role of companies like health pass companies will be to collect data from testing and medical providers and deliver status updates to partner companies in a secure, encrypted way that complies with the Health Insurance Portability and Accountability Act (HIPAA).

Source: https://www.billboard.com/articles/business/9480690/live-music-stock-prices-pfizer-vaccine-breakthrough/

[pueblo]

So to protect 1 person from getting Covid 256 people need to be vaccinated? This is what they call 95% efficacy!


Rapid Response:
Covid-19 vaccine candidate is unimpressive: NNTV is around 256

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


https://www.bmj.com/content/371/bmj.m4347/rr-4

[palehorse]

The vaccine thing is knocking our door, we have to be very careful about it. When I say "we" I mean the ones that will not take it, doesn't matter what include myself.
Thailand is the base Manufactory for the Southeast Asia block and I started to see some creepy information going around here, they are even talking about price, something around $10 /dose, but most people will not pay to get injected with trash I guess, vaccines are not popular in the common opinion here, it is well know only the elite (aka hi so) take it, the average civilian, has little or no vaccines throughout his entire life.
For the information I got from one public school, it is always asked for the parents to vaccinate their kids and it is not mandatory, I never heard any case of forced vaccination here, I will check the specific laws how it really works just to have the right argument when time comes.

[Karen (Geophyz)]

Hi Maia
In Sweden it´s the same. Our prime minister today had a pressconference where it seemed that Pfizer wrote the script for him. This is a big push coming in globally.
(I suspect I and a friend got the virus last week, and its not a big deal really. My friend lost his sense of smell and taste, but for me its ok. Its more like a cold)

My concern is what will show up in a few months time. What kind of damage will happen? I don't trust this hurried testing business. What IS the hurry anyway?
And why should we trust anything we're being told? They lied to us from the beginning. If they see that no one is following their agendas, they just get their lamestream liars to ramp up the fear mongering.... Some ppl can be frightened easily.

Here's a scary thought. Fortunately, coronavirus was not as devastating as we've been led to believe. We all figured out that you can't catch a virus anyway because our bodies are filled with trillions of viruses to begin with. They've been saying that a "second wave" is coming soon. Warned us about it. I say they tipped their hand instead. Here's the scary part: NOW they'll add a deadly GERM or BACTERIA to it that WILL ACTUALLY devastate all of us. And then dress us down for daring to doubt what they've been saying....

A word of comfort: The evil (meaning the members of the deep state) was allowed to rear its head, so that it can be judged. There is a Divine Plan....

I will not be taking this jab! I cannot believe it is safe in any way! As a scientist the testing procedure seems to have far to many flaws in it. I hope here in the US there will be many protests but I am afraid too many people are already sheep and will follow what every the Harris administration says.

[onawah]

First COVID-19 Vaccine 90% Effective?
by Dr. Joseph Mercola
November 18, 2020
https://articles.mercola.com/sites/articles/archive/2020/11/18/first-covid-19-vaccine-90-percent-effective.aspx?ui=8d3c7e22a03f5300d2e3338a0f080d2da3add85bca35e09236649153e4675f72&cid_source=dnl&cid_medium=email&cid_content=art1ReadMore&cid=20201118&mid=DM723337&rid=1014161188
K4GoqMsOnFU

"STORY AT-A-GLANCE
Pfizer, in a joint venture with BioNTech, announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, was “more than 90% effective” in a Phase 3 trial
While Pfizer did release a clinical protocol of its trial, it only issued a press release; data for the interim analysis has not been peer reviewed or published
Infectious disease expert William Haseltine criticized COVID-19 vaccine trials, including Pfizer’s, saying their protocols reveal that they’re “designed to prove their vaccines work, even if the measured effects are minimal”
Asymptomatic infections aren’t regularly being tested for in Pfizer’s trial, so it’s possible that those who have been vaccinated could still be asymptomatic carriers of COVID-19, spreading the disease to others
Also missing from Pfizer’s press release is how the vaccine fared in different age groups, a key data point since older people are those most at risk of serious disease outcomes
There is concern that COVID-19 vaccines could cause antibody-dependent enhancement, or ADE, in which the vaccine enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated
It’s far too soon to know whether the vaccine is safe, as, on average, it can take 10 to 12 years for a vaccine to be developed and go through the normal licensing process

With more than 180 COVID-19 vaccines currently in development1 — 53 of them undergoing clinical trials in humans2 — manufacturers are racing to be the first to reach the market. Pfizer, in a joint venture with Germany-based BioNTech, may have just taken the lead, with an announcement that their mRNA-based vaccine candidate, BNT162b2, was “more than 90% effective” in a Phase 3 trial.3

BNT162b2 was selected to move forward to a Phase 2/3 trial after an earlier version of the vaccine, BNT162b1— another mRNA-based vaccine candidate — resulted in considerable adverse events,4 including fever, which occurred in 50% of individuals who received the highest dose (100 micrograms), fatigue, headache and chills.

Side effects were even more common following the booster dose, after which more than 70% of participants experienced a fever at the mid-range (30 microgram) dose. In fact, those in the high-dose group didn’t even get the booster dose after the side effects were deemed to be potentially too severe.

While the vaccines are similar, with the BNT162b2 vaccine, mRNA encodes the full-length spike protein. A spike protein is a glycoprotein protruding from the envelope of a coronavirus that allows entry into the cell.5 In an earlier study, while BNT162b2 appeared to cause fewer side effects, antibody titers were lower in a group of older individuals, ranging in age from 65 to 95 years, than in younger individuals.6

Geometric mean titers (GMTs), which are used as a measure of immune response, were about 40% lower among older individuals given Pfizer’s BNT162b2 COVID-19 vaccine than they were in younger age groups, a concerning finding considering it’s the older individuals who are most at risk from severe COVID-19.

Is Pfizer’s COVID Vaccine Really 90% Effective?
In a Phase 3 efficacy trial, a vaccine is given to thousands of people, while researchers wait to see how many end up infected compared to those given a placebo.7 Pfizer’s Phase 3 clinical trial began July 27, 2020 and enrolled 43,538 participants8 to date ranging in age from 12 years to over 55, with a minimum of 40% of participants in the over 55 age range.9

Participants received either a two-dose series of BNT162b2, given at the 30-microgram dose 21 days apart, or a placebo. Initially an interim analysis was set to be conducted after 32 COVID-19 cases, but “after discussion with the FDA,” they increased it to after a minimum of 62 cases. According to Dr. Albert Bourla, Pfizer Chairman and CEO, in a press release:10

“Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC (Data Monitoring Committee) performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”

Bourla added the caveat, “As the study continues, the final vaccine efficacy percentage may vary.” In fact, there are many questions that remain unanswered regarding the reported 90% efficacy rate.

While Pfizer did release a clinical protocol of its trial,11 data for the interim analysis have not been released. "This is science by public pronouncement," William Haseltine, an infectious disease expert and former Harvard medical professor, told Business Insider.12

COVID-19 Vaccine Trials ‘Designed to Succeed’
In September 2020, Haseltine criticized COVID-19 vaccine trials, including Pfizer’s, saying their protocols reveal that they’re “designed to prove their vaccines work, even if the measured effects are minimal.”13

He points out that prevention of infection is a critical endpoint in a normal vaccine trial, but prevention of infection is not a criterion for success for COVID-19 vaccines in development by Pfizer, Moderna, AstraZeneca or Johnson & Johnson. According to Haseltine:14

“Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. Prevention of infection is not a criterion for success for any of these vaccines.

In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated. Measuring differences amongst only those infected by SARS-CoV-2 underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.”

He also explains that while most people expect that a vaccine will prevent serious illness in the event they’re infected, “Three of the vaccine protocols — Moderna, Pfizer, and AstraZeneca — do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.”15

Pfizer Didn’t Release Key Vaccine Data
While Pfizer is touting its vaccine as more than 90% effective based on 94 cases in their trial, "There are many, many outstanding questions which are left unanswered," Haseltine said.16

One of the main unanswered questions has to do with asymptomatic infections, which aren’t regularly being tested for in Pfizer’s trial. It’s possible, then, that those who have been vaccinated could still be asymptomatic carriers of COVID-19, spreading the disease to others.

"That's a major point that I don't think most people appreciate," Haseltine told Business Insider. "It doesn't mean an end to the epidemic."17 It’s also unknown whether the vaccine reduced the number of cases of serious disease, hospitalizations and deaths, as no distinction was made between serious COVID-19 cases and those causing only minor symptoms.

Also missing from Pfizer’s press release is how the vaccine fared in different age groups, a key data point since older people are those most at risk of serious disease outcomes. It also remains to be seen how long any protection offered by a vaccine may last, as the study just began in July.

As for side effects, Pfizer’s Bourla said, “The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.”18 Again, however, it’s far too soon to know whether the vaccine is safe. The timeline of the experimental COVID-19 vaccine is unprecedented as, on average, it can take 10 to 12 years for a vaccine to be developed and go through the normal licensing process.19

"We don't know anything about groups they didn't study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly," Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, told NBC News.20

As for potential adverse effects, in their clinical protocol Pfizer listed the following, noting that the first five participants in each group in phase 1 would be monitored for four hours after vaccination to assess adverse effects, while others would be observed for “at least 30 minutes.”21
Injection site redness, swelling and pain

Fever

Fatigue

Headache

Chills

Vomiting

Diarrhea

Muscle pain

Joint pain

Unknown adverse effects and laboratory abnormalities associated with a novel vaccine

Potential for increased exposure to SARS-CoV-2 because of the requirement to visit health care facilities during the trial

COVID-19 enhancement, stating, “Disease enhancement has been seen following vaccination with respiratory syncytial virus (RSV), feline coronavirus, and Dengue virus vaccines.”

Coronavirus Vaccines May Enhance Disease
Even Pfizer acknowledged in their clinical protocol that COVID-19 disease enhancement is a real risk following certain vaccinations.22 In what’s known as antibody-dependent enhancement, or ADE, or sometimes called paradoxical immune enhancement (PIE). In these scenarios rather than enhance your immunity against the infection, the vaccine enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated.23

Th2 immunopathology, in which a vaccine induces a faulty T cell response, triggering allergic inflammation, poorly functional antibodies and airway damage, is another serious risk.

Both ADE and Th2 immunopathology occurred in the 1960s when a vaccination for respiratory syncytial virus (RSV) was being developed, resulting in the death of two toddlers and serious illness in several other children who received the experimental vaccine.24

Similar concerns again surfaced in testing for a potential vaccine against another coronavirus, SARS, about 20 years ago. At the time, even long-time pro-vaccine advocate Dr. Peter Hotez, dean of the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, was shaken. According to a feature published in PNAS:25

“When SARS, also a coronavirus, appeared in China and spread globally nearly two decades ago, Hotez was among researchers who began investigating a potential vaccine.

In early tests of his candidate, he witnessed how immune cells of vaccinated animals attacked lung tissue, in much the same way that the RSV vaccine had resulted in immune cells attacking kids’ lungs. ‘I thought, ‘Oh crap,’’ he recalls, noting his initial fear that a safe vaccine may again not be possible.”

Despite years of additional research and alternative development strategies, immune enhancement concerns remain, and, as explained by Robert F. Kennedy Jr. in our 2020 interview, coronavirus vaccines remain notorious for creating paradoxical immune enhancement.

mRNA Is a Novel Vaccine Technology
Pfizer’s COVID-19 vaccine is relying on novel mRNA technology that has never previously been used in vaccines.26 It essentially instructs your cells to make the SARS-CoV-2 spike protein, which is what attaches to the ACE2 receptor of the cell. This is the first stage of the two-stage process viruses use to gain entry into cells.

The idea is that by creating the SARS-CoV-2 spike protein, your immune system will be stimulated to produce antibodies, without making you sick in the process. However, another key question that needs to be answered is which of two types of antibodies are produced through this process.

Coronaviruses produce both neutralizing antibodies,27 also referred to as immoglobulin G (IgG) antibodies, that fight the infection, and binding antibodies28 (also known as nonneutralizing antibodies) that cannot prevent viral infection. Instead of preventing viral infection, binding antibodies can trigger an abnormal immune response like ADE or PIE.

In trials of Moderna’s experimental COVID mRNA vaccine, 25 participants who received two doses of its low or medium dose vaccine had levels of binding antibodies — the type that are used by the immune system to fight the virus but do not prevent viral infections — at levels approximating or exceeding those found in the blood of patients who recovered from COVID-19.29

Data for the more significant neutralizing antibodies, which stop viruses from entering cells, were reported for only eight people.

Pfizer Has $1.95 Billion Deal With US Government
While the results of Pfizer’s Phase 3 trial remain murky, as part of Operation Warp Speed the drug giant has already struck a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense to provide Americans with 100 million doses of its COVID-19 vaccine after it is licensed — at no cost to recipients — with an option for 500 million additional doses.30 The agreement is part of Operation Warp Speed.

Pfizer and BioNTech also have a deal with the U.K. government for 30 million initial doses.31 The FDA’s guidance for a vaccine to receive Emergency Use Authorization requires only a median of two months of safety data following the second dose, which Pfizer expects to have by the third week of November.

At that point, they’re hoping to bring the experimental vaccine to market, with promises to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses, globally, in 2021.32 Upon Pfizer’s announcement that their vaccine showed 90% effectiveness, shares rose 16%. The next day, CEO Bourla sold 62% of his stock, an amount worth about $5.6 million.33

Does the Pfizer CEO know something we don’t? If and when the vaccine does become available, be sure to carefully weigh the risks versus the benefits before making a choice of whether or not to receive it.

It may help in your decision to know that if you’re under the age of 40, your risk of dying from COVID-19 is just 0.01%, meaning you have a 99.99% chance of surviving the infection34 — and you could improve that to 99.999% if you’re metabolically flexible and vitamin D replete."

+ Sources and References
1 Nature volume 586, pages516–527(2020)
2, 7 The New York Times November 10, 2020
3, 8, 10, 18, 32 Pfizer November 9, 2020
4, 6 Nature volume 586, pages516–527(2020), BNT162b1 and BNT162b2 from Pfizer
5 Merriam-Webster, Spike Protein
9 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19, Pages 14, 15
11 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19 in Healthy Individuals
12 Business Insider November 9, 2020
13, 14, 15, 16, 17 Forbes September 23, 2020
19 Eureka June 9, 2020
20 NBC News November 9, 2020
21, 22 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19, Pages 29 and 30
23 PNAS.org April 14, 2020 117 (15) 8218-8221
24, 25 PNAS.org April 14, 2020 117 (15) 8218-8221, Rogue responses
26 Pharmaceutical Technology May 1, 2020
27 Science Direct Neutralizing Antibody
28 Science Direct Binding Antibody
29 BioPharmaDive May 19, 2020
30 Pfizer July 22, 2020
31 Diazhub July 20, 2020
33 Zero Hedge November 11, 2020
34 Annals of Internal Medicine September 2, 2020 DOI: 10.7326/M20-5352
Colostrum More Effective Than Flu Vaccine
Baby Bottles Release Millions of Microplastic Particles

[Ernie Nemeth]

Why do you think Trump was pushing the therapeutics instead of a vaccine, always being careful not to say that the vaccines are untested and unsafe? Trump did not get a vaccine, he got Regeneron, which was just recently approved for emergency use.

Why do you think Trump pushed Vitamin D3 and zinc and hydroxychloroquine (spell check refuses to acknowledge that word, surprise, surprise - sorry if misspelled)?

These vaccines are a danger to society and to future generations.

We must root out the collaborators and we must punish them to the full extent of the law.

This is not a separate issue and should not be viewed as such. The vaccine push is a stated goal of the Gates Foundation for the decade just now coming to an end.

Lo and behold, the final months of the decade long push finds both the burgeoning will for worldwide vaccinations and a handy bug to demonize and rally support.

Operation Warpspeed is a scam. So are all the vaccines that are being pushed out in large numbers to combat it.

Maybe now all those zombie movies and shows might begin making more sense...in this context, it would be as predictive programming and future prognostication.

A news headline in the not too distant future:
Vaccines have an Unanticipated Side Effect...People Turning Into Zombies!

[pueblo]

Watching this now.

b1puMAcbW4hH

[Sue (Ayt)]

This appearance of massive future autoimmune reactions seems to me to be a distinct possibility of this new type of vaccine. I also notice the pharmaceutical/financial market revving up for marketing and promoting a slew of new drugs aimed at autoimmune diseases for the anticipated growth. Does make me wonder if there is a connection? $$$

Global Autoimmune Disorder Drug Delivery Devices Market to 2030 (https://www.prnewswire.com/news-releases/global-autoimmune-disorder-drug-delivery-devices-market-to-2030-301177285.html)
Autoimmune Disorder Therapies: Global Markets (https://finance.yahoo.com/news/autoimmune-disorder-therapies-global-markets-093200520.html)

--------------------------
Rapid Response:
Could COVID-19 mRNA vaccines cause autoimmune diseases?
Dear Editor,

Mass vaccination offers the best exit strategy from the COVID-19 pandemic. Pfizer/BioNTech's recent announcement, therefore, is encouraging.[1] Their vaccine candidate was more than 90% effective in preventing COVID-19 infection in participants without prior infection. Being an mRNA vaccine, mass production is cheaper and more straightforward than with other vaccine formulations.

mRNA vaccines effect coded protein production in the recipient’s body. In the case of COVID-19, inert spike (S) antigen proteins are produced. Normally, these enable SARS-CoV-2 coronavirus particles to enter host cells, but therapeutically, inoculation triggers humoral (antibody-mediated) acquired immunity.

Severe/fatal cases of COVID-19 are associated with immune hyperactivation and excessive cytokine release, leading to multiorgan failure. A broad range of mechanisms (with a final common pathway) appear to be involved. However, it has been suggested that molecular mimicry may contribute to this problem, with antibodies to SARS-CoV-2 spike glycoproteins cross-reacting with structurally similar host heptapeptide protein sequences (for example, in interleukin 7 and alveolar surfactant proteins), and raising an acute (auto)immune response against them.[2] Autoinflammatory dysregulation in genetically susceptible individuals, and other autoimmune mechanisms such as epitope spreading and bystander activation, might also contribute to acute but also chronic autoimmunity during and after COVID-19. [3]
In the understandable socioeconomic rush towards mass vaccination without longer-term safety testing, it would seem that an essential stage in any vaccine licensing process should involve careful analysis of the human proteome against vaccine peptide sequences. This should minimize the risks both of acute autoimmune reactions to inoculation and future chronic autoimmune pathology.

https://www.bmj.com/content/371/bmj.m4347/rr-6

References
1. Mahane E. Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate. BMJ 2020;371:m4347.
2. Ehrenfeld M, Tincani A, Andreoli L, et al. Covid-19 and autoimmunity. Autoimmun Rev 2020;19:102597.
3. Caso F, Costa L, Ruscitti P. Could Sars-coronavirus-2 trigger autoimmune and / or autoinflammatory mechanisms in genetically predisposed subjects? Autoimmun Rev 2020;19:102524.

[Le Chat]

The reason they do animal trials, by the way, which they skipped in this race to a vaccine, is to study long term adverse effects. This is because animals generally don't live as long as humans so a generational study can be fast tracked this way. Usually the animal trials go on for at least three years to be safe.

Why are animals still being used for testing drugs? If I ruled the world, convicted rapists, murderers and especially paedophiles would take the poor animals' places...