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).
Will America-First News Outlets Make it to 2023?
Things are looking grim for conservative and populist news sites.
There’s something happening behind the scenes at several popular conservative news outlets. 2021 was bad, but 2022 is proving to be disastrous for news sites that aren’t “playing ball” with the corporate media narrative. It’s being said that advertisers are cracking down, forcing some of the biggest ad networks like Google and Yahoo to pull their inventory from conservative outlets. This has had two major effects. First, it has cooled most conservative outlets from discussing “taboo” topics like Pandemic Panic Theater, voter fraud, or The Great Reset. Second, it has isolated those ad networks that aren’t playing ball.
Certain topics are anathema for most ad networks. Speaking out against vaccines or vaccine mandates is a certain path to being demonetized. Highlighting voter fraud in the 2020 and future elections is another instant advertising death penalty. Throw in truthful stories about climate change hysteria, Critical Race Theory, and the border crisis and it’s easy to understand how difficult it is for America-First news outlets to spread the facts, share conservative opinions, and still pay the bills.
Without naming names, I have been told of several news outlets who have been forced to either consolidate with larger organizations or who have backed down on covering certain topics out of fear of being “canceled” by the ad networks. I get it. This is a business for many of us and it’s not very profitable. Those of us who do this for a living are often barely squeaking by, so loss of additional revenue can often mean being forced to make cuts. That means not being able to cover the topics properly. Its a Catch-22: Tell the truth and lose the money necessary to keep telling the truth, or avoid the truth and make enough money to survive. Those who have chosen survival simply aren’t able to spread the truth properly.
We will never avoid the truth. The Lord will provide if it is His will. Our job is simply to share the facts, spread the Gospel, and educate as many Americans as possible while exposing the forces of evil.
To those who have the means, we ask that you please donate. We have options available now, but there is no telling when those options will cancel us. We just launched a new GiveSendGo page. We also have our GivingFuel page. There have been many who have been canceled by PayPal, but for now it’s still an option. Your generosity is what keeps these sites running and allows us to get the truth to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Thank you, and God Bless!