Banking on a Shot in the Dark. Big Pharma is Fast Tracking mRNA Vaccine Boosters, Ignoring all Scientific Protocols
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In recent months, two Pfizer officials have bragged about moving vaccine science forward at a speed that disallows proper scientific protocols from being followed, and the release of reformulated mRNA COVID boosters without testing is now the norm.
In November 2022, recently retired head of vaccine R&D at Pfizer, Kathrin Jansen, said “we flew the aeroplane while we were still building it. We couldn’t wait for data, we had to do so much at risk.” Pfizer compressed its vaccine development timeline from 10 years to a mere nine months by simultaneously developing and testing the product in human trials.
Pfizer and other COVID jab makers hid side effects by eliminating the control groups long before the studies were over
Vaccine makers are readying to release other mRNA shots, many of which are being fast-tracked and predicted to receive authorization in months rather than years. Moderna is working on a three-in-one shot for COVID, flu and RSV (respiratory syncytial virus), and they seem to expect releasing it before clinical trials are finished
Pfizer quoted and relied on data from Israel when it sought approval from the FDA, and as it turns out, the Israeli government hid information about side effects. It didn’t even implement its surveillance system until a year after the shots rolled out, and when the data were analyzed, researchers concluded there were causative links between certain side effects and the jabs
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In the video above, Del Bigtree with The Highwire reviews how the precautionary principle and long-standing safety guidelines in medicine have been eliminated with the COVID shots, and how data showing harms are being ignored, suppressed and manipulated to hide the truth.
In recent months, no less than two Pfizer officials have bragged about moving vaccine science forward at a speed that virtually guarantees that proper scientific protocols will be abandoned.
In early October 2022, during a COVID hearing in the European Parliament, Dutch member Rob Roos questioned Pfizer’s president of international developed markets, Janine Small, about whether Pfizer had in fact tested and confirmed that their mRNA jab would prevent transmission prior to its rollout.1
Small admitted that Pfizer never tested whether their jab would prevent transmission because they had to “move at the speed of science to understand what is happening in the market … and we had to do everything at risk.”
“We flew the aeroplane while we were still building it. We got creative — we couldn’t wait for data, we had to do so much ‘at risk.” ~ Kathrin Jansen, Pfizer vaccine R&D
Then, in November 2022, recently retired head of vaccine R&D at Pfizer, Kathrin Jansen, told an interviewer that “we flew the aeroplane while we were still building it.”2
As noted in that interview, Pfizer compressed its vaccine development timeline from 10 years to a mere nine months. Well, you cannot do that unless you cut certain corners and develop and test the product more or less simultaneously. In this case, human trials began even though the preliminary testing was extremely minimal. That’s what she’s talking about when she says they built the plane in midair.
They Did Everything at Your Risk
“We got creative — we couldn’t wait for data, we had to do so much ‘at risk,’” Jansen said. There are those words again — doing everything “at risk.” In other words, the risks were not part of the equation, and let’s be clear, the risk they’re referring to is the risk a person takes when they take the shot.
Pfizer’s primary focus was to create a shot that minimized the symptoms of infection, but aside from that, there was no time to assess side effects or long-term drawbacks of the technology, such as antibody-dependent enhancement, myocarditis, or spontaneous abortions.
This is probably why Pfizer and the other COVID jab makers all decided to eliminate the control groups long before the studies were even over. This way, side effects could be hidden, and we see the effects of that decision now.
Myocarditis, blood clots, lethal heart attacks, strokes, cancer and sudden death are all skyrocketing, but since there’s no official control group to compare with, those trends are written off as either normal or coincidental. You’ve probably seen that heart attacks are now blamed on everything from hot weather and cold showers to soil microbes in your garden, climate change and loud noises.
So, a more accurate statement would be that Pfizer did everything “at your risk.” They risk nothing. They get paid whether the shots work or not, and they have zero liability for injuries and deaths, financial or otherwise. The person who takes on all the risk is the one who takes the shot. They could lose their health, their career, everything they own and their very life.
Jansen admits “the mRNA platform wasn’t ready for prime time” when they decided to use it, and that there were stability and formulation issues, all of which were literally decided on the fly, often based on little or no data.
To her credit, Jansen stresses that this is “not a model for the future,” because “it’s not sustainable” to be working at warp speed all the time. Unfortunately, those who are continuing this work apparently disagree, because warp speed rollout with minimal or no testing is, in fact, the new norm already.
Warp Speed Is the New Norm
We know warp speed is the new norm because of a decision made by the U.S. Food and Drug Administration this past summer. During its June 28, 2022, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, they approved a bivalent COVID shot for fall 2022.3
With that vote, they sneaked in a whole new policy, a new framework, under which reformulated COVID shots will be treated as biologically similar to existing shots and therefore be allowed to skip clinical trials.
During that meeting, they were originally scheduled to vote on the Future Framework policy question of whether reformulated shots should be treated as new molecular entities subject to formal review. They never addressed that policy question and instead skipped right to the vote on a bivalent COVID shot for the fall.
By approving it, knowing there would be no time for testing and data gathering, they replaced the old evidence-based system through a sleight of hand. The bivalent shots received emergency use authorization (EUA) at the end of August 2022, based on the antibody levels in eight mice.
Moderna, which received EUA for its bivalent booster at the same time as Pfizer, also used mice to ascertain antibody responses, but has not disclosed the number of mice used.
So, clearly, we are still moving at warp speed, without regard for risk. And already, vaccine makers are readying to release other mRNA shots, many of which are being fast-tracked and predicted to receive authorization in months rather than years.
Other mRNA Approvals Expected With Little or No Data
For example, Moderna is working on a three-in-one shot for COVID, flu and RSV (respiratory syncytial virus), and they seem to fully expect releasing it before clinical trials are finished. As reported by CBC News:4
“Moderna is actively promoting a combined COVID-19, flu and RSV vaccine … But while a safe and effective vaccine would be welcome as Canada faces a surge in pediatric RSV cases, stubbornly high COVID hospitalizations and deaths and steeply rising flu cases, the pharmaceutical company hasn’t released data to support the vaccine’s safety or efficacy …
Moderna’s decision to promote its vaccine before completing Phase 3 clinical trials — in which the vaccine would be tested on a larger group as part of a randomized, double-blind study — is controversial. It’s also raised concerns from vaccine researchers and infectious diseases experts about the motivations behind prematurely marketing the shot.
‘There’s still more questions than answers, obviously, with releases like this that come from companies without accompanying data,’ said Matthew Miller, a vaccine researcher and associate professor of infectious diseases and immunology at McMaster University.
‘I think we need to be really cautious. We have no data on safety, no data on effectiveness or efficacy or age groups. How would you handle updating various components of that vaccine? Lots and lots of questions’ …
Developing a vaccine for RSV, let alone combining one with COVID and flu, is no small feat — and the complications around dosing, timing and age considerations could pose major challenges for the vaccine maker down the road.
‘Having a single formulation increases the complexity of updating that formulation annually,’ said Miller … ‘So now, instead of dealing with four flu strains, you’re adding in RSV and COVID and having a combined shot might actually be more complex in some ways than having separate formulations that are co-administered at the same time.’”
In addition to fast-tracking mRNA injections for a variety of respiratory viruses, vaccine makers are also loading their pipelines with mRNA shots for diseases such as cancer, multiple sclerosis (MS), birth defects and rarer diseases.
Curiously, while mRNA shots are being hailed as the new and improved answer for every ill, Moderna president Stephen Hoge and chief technical officer Juan Andres cashed out hundreds of millions of their stock options earlier this year,5 which seems odd if everything is going well and no future trouble is expected.
Government and Corporate Interests Have Become One
Aiding and abetting the circumvention of the precautionary principle are contract research firms that run medical research trials for drug companies and federal agencies alike, thereby giving the drug companies the inside track on drug approvals.6,7
As noted by investigative journalist Paul Thacker, the COVID pandemic has erased the boundaries between corporate interests and those of our government, and with that, there are few left to trust.
“Talk about foxes guarding the henhouse,” Thacker writes.8 “Or, maybe, one fox raising and caring for the hens, another alerting the farmer when it’s time for dinner — and a third setting the farmhouse table for a feast.
That is the highly murky and incredibly profitable world of contract research organizations (CROs), private companies that specialize in recruiting patients and running medical research trials.
In the last handful of years, the [FDA] contracted a CRO to work with the National Institutes of Health to determine how companies run some drug trials; Pfizer hired a CRO to run their COVID-19 vaccine trial; a CRO calmed fears about the safety of AstraZeneca’s COVID-19 vaccine after the FDA and NIH raised safety data concerns.
And just a few weeks back the federal government awarded a CRO a contract to run an anthrax vaccine trial to prepare for a biological attack. And here’s the funny thing. All this overlapping and interconnected corporate and government work involves the exact same CRO: ICON.”
Thacker contacted the Department of Health and Human Services (HHS), asking them to explain “how ICON can run clinical trials for federal agencies while also helping private companies gain federal approval,” and “what HHS does to ensure ICON’s federal work benefits taxpayers and not their private clients.”
After initially getting the runaround he was eventually told to ask ICON to explain their “internal firewalls.” The HHS spokesperson did promise to send Thacker “language HHS puts in contracts to ensure research organizations like ICON protect against conflicts of interest,” but he never did. Make of that what you will.
FDA Authorized Pfizer Jab Based on Questionable Data
"The Ministry of Health in Israel is actively hiding critical information abt side effects from the Israeli public…Why is that important?…[In] all the approval stages of the FDA…Pfizer is quoting & relying on data from Israel." —MIT professor Retsef Levi
👇PREMIERE 7:30pm ET! pic.twitter.com/KJSRbnNAeW
— Jan Jekielek (@JanJekielek) November 15, 2022
Making an already dangerous situation worse, vaccine companies and governments are working overtime to hide and suppress data showing the COVID jabs are a medical disaster, and have hidden unfavorable data from the very beginning. The basic data gathering has also been shockingly lax across the world, considering the stakes.
As noted by MIT professor Retsef Levi in The Epoch Times interview above,9,10 Pfizer quoted and relied on data from Israel when it sought approval from the FDA, and as it turns out, the Israeli government hid information about side effects.
Even more surprising, Levi claims the Israeli government lied when it said it had a robust system for monitoring and tracking side effects from the start. That surveillance system wasn’t launched until a year after the rollout of the shots, Levi says. A research team was eventually hired to analyze the data, and their findings were disconcerting.
Unlike what was told to the public, many of the side effects were both common and long-lasting. The Ministry of Health was advised to think in terms of “medical-legal” when communicating this to the public, as the Ministry might be held liable for telling the public side effects were rare and of short duration.
In other words, they were informed they’d grossly misinformed the public and could be held accountable for injuries. The Ministry’s solution? Fire the research team and alter the report’s data and conclusions.
In the interview, Levi explains how some of the data manipulation was done. For example, they massively lowered the number of post-jab menstrual irregularities by counting both women and men. You don’t need to be a scientist to realize that by counting men, who cannot menstruate, you end up with a wild misrepresentation of the incidence of menstrual irregularities.
Most egregious of all, the Ministry hid the fact that the research team found clear evidence of causality, as patients, when rechallenged with another dose, would experience a resurgence of symptoms and/or a worsening of symptoms. Adding insult to injury, even though the Ministry knows exactly who these patients are, they have not reached out to help them medically or compensate them for injuries that have been clearly linked to the shots.
Excess Death Rates Continue to Climb
Mortality statistics also reveal we’ve been sold a sack of lies. In the video above, nurse instructor John Campbell, Ph.D., reviews some of the latest excess death statistics from the U.K., which show that, in October 2022, the average weekly excess death rate was 1,564.
In 2020, the average weekly excess death rate was a mere 315, and in 2021 it was 1,322. For the week ending October 21, 2022, the excess mortality was 1,822, which is 15.7% above the five-year average.
So, there are now far more non-COVID deaths than there were COVID deaths during the height of the pandemic, before there were any COVID jabs. In particular, data from the King’s Fund show excess deaths from cardiovascular disease and diabetes are mounting.11
Yet, while the number of people dying were a media obsession during 2020 and 2021, now that the death toll is far greater than what we saw at any point during the pandemic, mainstream media remain quiet, and seem completely uninterested in finding out why people are dying at historically unprecedented rates.
Autumn Booster Campaigns Leave Death in Its Wake
The Daily Sceptic also reported striking parallels between the autumn booster campaign, specifically, and excess deaths in the U.K.:12
“Potential new support for the role of the vaccines [in excess non-COVID deaths] can be seen in the chart below. I have plotted the autumn vaccine doses in the over-75s (the age group which makes up the large majority of deaths) and excess non-COVID death occurrences (in red), revealing a striking correlation … COVID death occurrences (in blue), on the other hand, rise and peak several weeks later.
… [The] Scottish Unity Edinburgh Group sent me this chart showing a similar correlation in Scotland between deaths and the autumn booster rollout.”
New Zealand Booster Campaign Linked to Excess Deaths
Similarly, an earlier study13,14,15 published June 28, 2022, found that, in New Zealand, the age groups that were most likely to have received a COVID booster in the winter of 2021 had 7% to 10% more excess deaths than age groups that were ineligible for boosters. The graph below illustrates how the rise in excess mortality coincided with booster uptake. According to the study’s author, economics professor John Gibson:16
“The results suggest 16 … excess deaths per 100,000 booster doses, amounting to over 400 excess deaths in New Zealand given the booster doses administered to date. If this rate of excess deaths is extrapolated to other countries, it amounts to over 300,000 excess deaths worldwide …
The ratio of vaccine risk to benefits likely has swung more towards risk than during the original randomized trials, due to dose-dependent adverse events and to fixation of immune responses on a variant no longer circulating.”
I, for one, am not surprised by these kinds of statistics, and I don’t think vaccine makers are either. When you take off in an unfinished plane, crashing is to be expected because, in the real world, you cannot build planes in midair. Likewise, in the real world, you have to do extensive, long-term testing, starting in animals, to be sure a drug is safe. The concept of fast-tracking has been proven a dangerous failure. How long will it take before government and industry admit it?
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Notes
1 Twitter Rob Roos October 11, 2022
6, 8 Disinformation Chronicle November 1, 2022
7 Twitter Paul Thacker November 4, 2022
9 Twitter Jan Jekielek November 15, 2022
10 The Epoch Times Retsef Levi Interview
12 The Daily Sceptic November 10, 2022
14 Clark County Today July 18, 2022
15, 16 The Expose July 7, 2022
Featured image is from Children’s Health Defense
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