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Brownstone Institute

FOIA Doc Shows BioNTech Founders Postdated Start of C19 Vax Project

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From the Brownstone Institute

BY Robert KogonROBERT KOGON

As noted in my last article on BioNTech’s “brazen” avoidance of safety testing of its Covid-19 vaccine, BioNTech founders Ugur Sahin and Özlem Türeci claim in their book The Vaccine that the company’s Covid-19 vaccine project got underway on January 27, 2020. But documentary evidence released in response to a FOIA request (and included in the so-called “Pfizer documents”) shows that this is not true and that the company had in fact already begun preclinical, i.e. animal, testing nearly two weeks earlier, on January 14.

BioNTech R&D STUDY REPORT No. R-20-0072 is available here. The report is also referenced and discussed in an FDA submission on the preclinical study program that is available here. The below screenshot shows the study dates from p. 8 of the report.

In the book, Sahin claims furthermore that he only even became interested in the outbreak in Wuhan on January 24, after reading an article in the German weekly Der Spiegel (p. 4) and/or a submission to The Lancet (p. 6). But look again at the study dates above. BioNTech had already completed the first preclinical study for its Covid-19 vaccine the day before!

January 24, 2020 was a Friday. On Sahin’s account, he took the decision to launch his Covid-19 vaccine project over the weekend and unveiled his plans to his collaborators at BioNTech’s headquarters in Mainz, Germany on the following Monday: January 27 (ch. 2 passim and p. 42; see screencap below).

Sahin claims (p. 33) that it was at this January 27 meeting that he asked BioNTech’s animal testing team to prepare the preclinical program that was in fact already underway!

It should be noted that January 14, 2020, the start-date of the first preclinical study, was just two weeks after the first report of Covid-19 cases in Wuhan and just a day after the release of the full SARS-CoV-2 genome (drafts had been released previously).

BioNTech’s first preclinical study was evidently prepared before publication of the genome and in anticipation of it. As explained in the summary of the study (p. 6), its purpose was to test BioNTech mRNA formulated in lipid nanoparticles produced by the Canadian firm Acuitas. But the mRNA was here encoding a proxy antigen (luciferase), not the spike protein of SARS-CoV-2 that would later serve as the target antigen.

The study looked at both biodistribution and immune system activation. As the FDA submission on the preclinical program puts it, “Platform properties that support BNT162b2 were initially demonstrated with non-SARS-CoV-2 antigens” (2.4 NONCLINICAL OVERVIEW, p. 7).

In The Vaccine, which was written with the journalist Joe Miller, Sahin and Türeci talk about the need to obtain the Acuitas lipids, which, they say, were more suitable for intramuscular injection than BioNTech’s own in-house lipids. But, again, they postdate the matter. Thus, on p. 52, we read: “The missing piece was still Acuitas, who had not yet consented to the use of their lipids. Then, on the morning of Monday 3 February, [Acuitas CEO] Tom Madden offered his help.” But BioNTech was already running tests using the Acuitas lipids three weeks earlier!

Furthermore, BioNTech was not able to formulate its mRNA into the lipids itself, but depended on the Austrian company Polymun to do this for it. As noted in The Vaccine (p.51), Polymun’s facilities are an 8-hour drive from BioNTech’s headquarters in Mainz. In the book, Sahin and Türeci describe the first batch of mRNA for the vaccine tests proper being packed up and driven by car to Polymun outside Vienna: “A couple of days later, a small Styrofoam box containing frozen vials full of vaccine would be driven back over the border to BioNTech” (pp. 116-117).

But presumably this same back-and-forth had to have occurred with the mRNA encoding the luciferase. This means that as a practical matter “Project Lightspeed” must have gotten underway even earlier: at least several days before the January 14 start date of the study.

Why did Sahin and Türeci postdate the launch of their Covid-19 vaccine project in their book? Well, undoubtedly because the actual start date – and we do not know when exactly the actual start date was – would have seemed far too soon. Based on the above considerations, it must have been at the latest just days after the first December 31, 2019 report of Covid-19 cases in Wuhan.

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  • Robert Kogon

    Robert Kogon is a pen name for a widely-published financial journalist, a translator, and researcher working in Europe. Follow him at Twitter here. He writes at edv1694.substack.com.

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Brownstone Institute

It’s Time to Retire ‘Misinformation’

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From the Brownstone Institute

By  Pierre Kory 

This article was co-authored with Mary Beth Pfieffer.

In a seismic political shift, Republicans have laid claim to an issue that Democrats left in the gutter—the declining health of Americans. True, it took a Democrat with a famous name to ask why so many people are chronically illdisabled, and dying younger than in 47 other countries. But the message resonated with the GOP.

We have a proposal in this unfolding milieu. Let’s have a serious, nuanced discussion. Let’s retire labels that have been weaponized against Robert F. Kennedy, Jr., nominated for Health and Human Services Secretary, and many people like him.

Start with discarding threadbare words like “conspiracy theory,” “anti-vax,” and the ever-changing “misinformation.”

These linguistic sleights of hand have been deployed—by government, media, and vested interests—to dismiss policy critics and thwart debate. If post-election developments tell us anything, it is that such scorn may no longer work for a population skeptical of government overreach.

Although RFK has been lambasted for months in the press, he just scored a 47 percent approval rating in a CBS poll.

Americans are asking: Is RFK on to something?

Perhaps, as he contends, a 1986 law that all but absolved vaccine manufacturers from liability has spawned an industry driven more by profit than protection.

Maybe Americans agree with RFK that the FDA, which gets 69 percent of its budget from pharmaceutical companies, is potentially compromised. Maybe Big Pharma, similarly, gets a free pass from the television news media that it generously supports. The US and New Zealand, incidentally, are the only nations on earth that allow “direct-to-consumer” TV ads.

Finally, just maybe there’s a straight line from this unhealthy alliance to the growing list of 80 childhood shots, inevitably approved after cursory industry studies with no placebo controls. The Hepatitis B vaccine trial, for one, monitored the effects on newborns for just five days. Babies are given three doses of this questionably necessary product—intended to prevent a disease spread through sex and drug use.

Pointing out such conflicts and flaws earns critics a label: “anti-vaxxer.”

Misinformation?

If RFK is accused of being extreme or misdirected, consider the Covid-19 axioms that Americans were told by their government.

The first: The pandemic started in animals in Wuhan, China. To think otherwise, Wikipedia states, is a “conspiracy theory,” fueled by “misplaced suspicion” and “anti-Chinese racism.”

Not so fast. In a new 520-page report, a Congressional subcommittee linked the outbreak to risky US-supported virus research at a Wuhan lab at the pandemic epicenter. After 25 hearings, the subcommittee found no evidence of “natural origin.”

Is the report a slam dunk? Maybe not. But neither is an outright dismissal of a lab leak.

The same goes for other pandemic dogma, including the utility of (ineffective) masks, (harmful) lockdowns, (arbitrary) six-foot spacing, and, most prominently, vaccines that millions were coerced to take and that harmed some.

Americans were told, wrongly, that two shots would prevent Covid and stop the spread. Natural immunity from previous infection was ignored to maximize vaccine uptake.

Yet there was scant scientific support for vaccinating babies with little risk, which few other countries did; pregnant women (whose deaths soared 40 percent after the rollout), and healthy adolescents, including some who suffered a heart injury called myocarditis. The CDC calls the condition “rare;” but a new study found 223 times more cases in 2021 than the average for all vaccines in the previous 30 years.

Truth Muzzled?

Beyond this, pandemic decrees were not open to question. Millions of social media posts were removed at the behest of the White House. The ranks grew both of well-funded fact-checkers and retractions of countervailing science.

The FDA, meantime, created a popular and false storyline that the Nobel Prize-winning early-treatment drug ivermectin was for horses, not people, and might cause coma and death. Under pressure from a federal court, the FDA removed its infamous webpage, but not before it cleared the way for unapproved vaccines, possible under the law only if no alternative was available.

An emergency situation can spawn official missteps. But they become insidious when dissent is suppressed and truth is molded to fit a narrative.

The government’s failures of transparency and oversight are why we are at this juncture today. RFK—should he overcome powerful opposition—may have the last word.

The conversation he proposes won’t mean the end of vaccines or of respect for science. It will mean accountability for what happened in Covid and reform of a dysfunctional system that made it possible.

Republished from RealClearHealth

Author

Dr. Pierre Kory is a Pulmonary and Critical Care Specialist, Teacher/Researcher. He is also the President Emeritus of the non-profit organization Front Line COVID-19 Critical Care Alliance whose mission is to develop the most effective, evidence/expertise-based COVID-19 treatment protocols.

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Brownstone Institute

The Cure for Vaccine Skepticism

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From the Brownstone Institute

By Martin Kulldorff Martin Kulldorff 

The only way to restore public trust in vaccination – which has taken a big hit since the lies attending the rollout of the Covid-19 vaccine – is to put a well-known vaccine skeptic in charge of the vaccine research agenda. The ideal person for this is Robert F. Kennedy, Jr., who has been nominated to lead the Department of Health and Human Services.

At the same time, we must put rigorous scientists with a proven track record of evidence-based medicine in charge of determining the type of study designs to use. Two ideal scientists for this are Dr. Jay Bhattacharya and Dr. Marty Makary, who have been nominated to lead the NIH and FDA, respectively.

Vaccines are – along with antibiotics, anesthesia, and sanitation – one of the most significant health inventions in history. First conceived in 1774 by Benjamin Jesty, a farmer in Dorsetshire, England, the smallpox vaccine alone has saved millions of lives. Operation Warp Speed, which rapidly developed the Covid vaccines, saved many older Americans. Despite this, we have seen a sharp increase in general vaccine hesitancy. Vaccine scientists and public health officials who did not conduct properly randomized trials made false claims about vaccine efficacy and safety and established vaccine mandates for people who did not need the vaccines, sowing suspicion and damaging public trust in vaccination.

What went wrong? The purpose of the Covid vaccines was to reduce mortality and hospitalization, but the randomized trials were only designed to demonstrate short-term reduction in Covid symptoms, which is not of great public health importance. Since the placebo groups were promptly vaccinated after the emergency approval, they also failed to provide reliable information about adverse reactions. Despite these flaws, it was falsely claimed that vaccine-induced immunity is superior to natural infection-acquired immunity and that the vaccines would prevent infection and transmission.

Governments and universities then mandated the vaccines for people with superior natural immunity and for young people with very low mortality risk. These mandates were not only unscientific but with a limited vaccine supply, it was unethical to vaccinate low-mortality-risk people when the vaccines were needed by older high-risk people around the world.

Since government and pharmaceutical companies lied about the Covid vaccine, are they also lying about other vaccines? Skepticism has now spread to tried-and-true vaccines that are proven to work.

And there are real, unanswered vaccine safety questions. Seminal work from Denmark has shown that vaccines can have both positive and negative non-specific effects on non-targeted diseases, and that is something that must be explored in greater depth. Vaccine Safety Datalink (VSD) scientists studying asthma and aluminum-containing vaccines concluded that while their “findings do not constitute strong evidence for questioning the safety of aluminum in vaccines…additional examination of this hypothesis appears warranted.”

While VSD and other scientists should continue to do observational studies, we should also conduct randomized placebo-controlled vaccine trials, as RFK has advocated. Since we have herd immunity for many diseases, such as measles, trials can be ethically conducted by randomizing the age of vaccination to, for example, one versus three years old, while spreading the trial over a large geographical area so that the unvaccinated are not all living close to each other.

I am confident that most vaccines will continue to be found safe and effective. While some problems may be found, that is more likely to increase rather than decrease vaccine confidence. For instance, it was found that the measles-mumps-rubella-varicella (MMRV) vaccine causes excess febrile seizures in 12- to 23-month-old children. MMRV is now only given as a second dose to older children, while the younger kids get separate MMR and varicella vaccines, resulting in fewer vaccine-induced seizures that scare parents. Although safety studies were inconclusive, it was also wise to remove mercury from vaccines. Even if we end up with fewer vaccines in the recommended vaccine schedule, that’s not necessarily a terrible thing. Scandinavia has a very healthy population with fewer vaccines in their schedules.

We won’t restore vaccine confidence by preaching to the choir. After the Covid debacle, Kennedy’s stated goal is to return to evidence-based medicine free from conflicts of interest. Letting him do that is the only way that skeptics will trust vaccines again, and those of us who trust vaccines have no reason to be afraid of that.

Attempts by the public health and pharma establishments to derail the nominations of RFK, Bhattacharya, and Makary are the surest way to further increase vaccine hesitancy in America. The choice is stark. We cannot let lopsided “pro-vaccine scientists” who clamp their hands over their ears at the mildest questions do any more harm to vaccine confidence. As a pro-vaccine scientist, and in fact, the only person ever being fired by the CDC for being too pro-vaccine, the choice is clear in my mind. To restore vaccine confidence to previous levels, we must support the nominations of Kennedy, Bhattacharya, and Makary.

Republished from RealClearPolitics

Author

Martin Kulldorff

Martin Kulldorff is an epidemiologist and biostatistician. He is Professor of Medicine at Harvard University (on leave) and a Fellow at the Academy of Science and Freedom. His research focuses on infectious disease outbreaks and the monitoring of vaccine and drug safety, for which he has developed the free SaTScan, TreeScan, and RSequential software. Co-Author of the Great Barrington Declaration.

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