From the beginning of the COVID-19 crisis, the risk factors for severe forms and death from – or “with” – the respiratory virus called SARS-CoV-2 had been clearly identified: Advanced age, obesity, severe chronic comorbidities (other diseases, e.g. hypertension, diabetes, cancer).
For people without any of these characteristics, the risk of dying from (or even only “in relation with”) COVID-19 is very low and close to 0.
The vaccines are supposed to prevent severe disease and death; otherwise, they – and a fortiori their expedited approvals – would be entirely pointless.
At this point in time however, we still cannot possibly know whether they actually do. Martin Kulldorf is therefore entirely right when he demands in his recent article that the manufacturers “conduct a proper randomized clinical trial that proves that the vaccines reduce mortality.”
The design and execution of such a trial – in the high risk group (e.g. >65 years of age, plus at least one comorbidity), over a reasonable timeframe (at least 6 months), comparing overall (not only test-positive) mortality in a placebo to a verum-group – would have been (and would still be) straightforward and much less complex than the registration studies that were in fact carried out with these products.
How the trials were conducted is clearly stated in the protocols, publications, and FDA submissions: People who developed symptoms (the lists of these symptoms changed a little from one manufacturer to another, but they were all non-specific common cold or flu symptoms) underwent PCR testing. If – and only if – the test turned out to be positive (in the Pfizer study, this was the case in merely 170 out of more than 3,400 symptomatic patients), the endpoint of “symptomatic Covid-19” was considered as having been reached.
What these studies showed was that in people presenting with common cold or flu symptoms, the SARS-CoV-2 virus was detected significantly less frequently in the vaccinated than in the placebo group.
What was thus demonstrated was in no way a reduction in any clinically defined and distinguishable disease entity, but only in the number of positive tests for one particular virus of many which are known to cause the non-specific symptoms in question.
What was not demonstrated however, was a reduction in common cold and flu symptoms per se. Quite the contrary.
All the observational studies which have been carried out with the Covid-19 vaccines suffer, apart from some of the well-known general biases, from exactly the same fundamental flaw: They show a decrease in “Covid-19-related” symptom-free or symptomatic cases, hospitalizations or deaths, but they do not ask the question whether this decline in test-positive patients translates into an overall reduction of flu cases, of (atypical) pneumonias, of hospitalizations and deaths.
However, this is the clinically truly relevant question.
It is impossible to draw any firm conclusions from the data on the vaccines’ effect on general mortality which have been published up to now. The recent Danish analysis, apparently submitted to the LANCET, is again entirely correct when it argues “for performing RCTs of mRNA and adeno-vectored vaccines … comparing long-term effects on overall mortality.”
These RCTs (Randomized Clinical Trials) absolutely need also to, and above all, include a Placebo group, and not just compare the vaccines with each other though.
The apparent superiority of the DNA-vector vaccines, as reported by the Danish group, is based on very small numbers with little inherent reliability. Moreover, one needs to be extremely careful with post-hoc statistical analyses on clinical endpoints which had not been pre-defined for the trial(s) in question – this can very quickly become akin to “data dredging.”
Overall mortality has not been an endpoint in any of the Covid vaccine trials or studies so far. Conceptually, as the Covid mortality is part of the unavoidable mortality of the general population (we are not immortal, and on average we die at our average age of death), it may be impossible to demonstrate a general mortality benefit for the Covid vaccines – even more so as they do have potentially severe side effects.
But properly conducted clinical trials with relevant (“hard”) clinical endpoints are the only way to find out and conclude.
About the Author
Manfred Horst, MD, PhD, MBA, studied medicine in Munich, Montpellier and London. He spent most of his career in the pharmaceutical industry, most recently in the research & development department of Merck & Co/MSD. Since 2017, he had been working as an independent consultant for pharma, biotech and healthcare companies (www.manfred-horst-consulting.com).
Big Pharma’s Five Major Minions that Everyone, Vaxxed or Unvaxxed, Must Oppose
This is not an “anti-vaxxer” article, per se. It’s a call for everyone to wake up to the nefarious motives behind vaccine mandates, booster shots, and condemnation of freedom.
The worst kept secret in world history SHOULD be that the unquenchable push for universal vaccinations against Covid-19 has little if anything to do with healthcare and everything to do with Big Pharma’s influence over the narrative. Unfortunately, that secret has stayed firmly hidden from the vast majority of people because of the five major minions working on behalf of Big Pharma.
What’s even worse is the fact that Big Pharma’s greed is merely a smokescreen to hide an even darker secret. We’ll tackle that later. First, let’s look at the public-facing ringleaders behind the vaccine push, namely Big Pharma. But before we get into their five major minions, it’s important to understand one thing. This is NOT just an article that speaks to the unvaccinated. Even those who believe in the safety and effectiveness of the vaccines must be made aware of agenda that’s at play.
Let’s start with some facts. The unvaccinated do NOT spread Covid-19 more rampantly than the vaccinated. Even Anthony Fauci acknowledged the viral load present in vaccinated people is just as high as in the unvaccinated. This fact alone should demolish the vaccine mandates as it demonstrates they have absolutely no effect on the spread of the disease. But wait! There’s definitely more.
This unhinged push to vaccinate everyone defies science. Those with natural immunity may actually have their stronger defenses against Covid-19 hampered by the introduction of the injections which fool the body into creating less-effective antibodies. Moreover, the push to vaccinate young people is completely bonkers. The recovery rate for those under the age of 20 is astronomical. Children neither contract, spread, nor succumb to Covid-19 in a statistically meaningful way. What they DO succumb to more often than Covid-19 are the adverse reactions to the vaccines, particularly boys.
All of this is known and accepted by the medical community, yet most Americans are still following the vaccinate-everybody script. It requires pure cognitive dissonance and an overabundant need for confirmation bias to make doctors and scientists willingly go along with the program. Yet, here we are and that should tell you something.
Before I get to the five major minions of of Big Pharma, I must make the plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our GivingFuel page or via PayPal. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Who does Big Pharma control? It starts with the obvious people, the ones who most Americans believe are actually behind this push. Our governments at all levels as well as governments around the world are not working with Big Pharma. They are working for Big Pharma. Some are proactive as direct recipients of cash. Others may oppose Big Pharma in spirit but would never speak out because they know anyone who does has no future in DC.
This may come as a shock to some, but it’s Big Pharma that drives the narrative and sets the agenda for the “experts” at the CDC, FDA, WHO, NIH, NIAID, and even non-medical government organizations.
Most believe it’s the other way around. They think that Big Pharma is beholden to the FDA for approval, but that’s not exactly the case. They need approval for a majority of their projects, but when it comes to the important ones such as the Covid injections, Big Pharma is calling the shots. They have the right people in the right places to push their machinations forward.
That’s not to say that everyone at the FDA is in on it. Big Pharma only needs a handful of friendlies planted in leadership in order to have their big wishes met. We have seen people quitting the FDA in recent weeks for this very reason. The same can be said about the other three- and five-letter agencies. Too many people in leadership have been bribed, bullied, or blackmailed into becoming occasional shills for the various Big Pharma corporations. Some have even been directly planted by Big Pharma. That’s the politics of healthcare and science that drives such things as Covid-19 “vaccines.”
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JD Rucker – EIC