A phase 1 study of a corona gene vaccine showed a side effect rate of up to 100% in fully healthy adult test subjects. But the authors are happy about the ‘robust immune response’. The manufacturer is starting to produce up to 1 billion vaccine doses.
by Hans U. P. Tolzin Impfkritik.de July 18, 2020, (last update: July 20, 2020)
In spring of 2020, a mRNA vaccine against corona virus by manufacturer Moderna was tested on behalf of the U.S. health authorities. An interim report was published on July 14th. Here is the study
A total of 45 healthy subjects between the ages of 18 and 55 received different doses of an experimental mRNA vaccine against the coronavirus.
The first vaccination was given on March 16 and the second vaccination on April 14, 2020, 28 days later.
Subjects were divided in 3 groups of 15 test subjects, were each received a dose of either 25, 100 or 250 micrograms of the vaccine.
The antibody titers measures were high after the first as well as after the second vaccination, especially in the highest dose group. We do not know whether this means better health, because according to the German Robert Kock institute there are no studies linking antibody-titer to health outcomes. Source
Mild systemic side effects after the first vaccination were reported for:
5 subjects of 15 (33%) in the 25 microgram group
10 test subjects out of 15 (67%) in the 100 microgram group
8 subjects out of 15 (53%) in the 250 microgram group
Systemic side effects after the second vaccination were reported for:
7 subjects out of 13 (54%) in the 25 microgram group
15 subjects out of 15 (100%) in the 100 microgram group
14 subjects out of 14 (100%) in the 250 microgram group
3 out of 14 subjects (21%) in the high dose group had up to 3 severe systemic side effects after the second vaccination.
A total of three out of 45 (7%) test subjects had to be removed from the study after the first vaccination: One test subject from the low-dose group suffered from urticaria on both legs (hives) 5 days after the vaccination. Two subjects (one from the low and one from the high dose group) had to be isolated because of suspected Covid-19. The test results were ultimately negative.
The Solicited “mild” adverse effects that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.”
The authors of the study concluded: The mRNA-1273 vaccine elicited anti-SARS-CoV-2 immune responses in all subjects. No safety concerns that could have led to the termination of the study were identified. The results would support further development of this vaccine.
Commentary by Hans Tolzin:
Even though the study was funded by the health authorities in the USA, employees of the manufacturer were involved in the study. This alone can lead to an intentional or unintentional distortion of the results.
The test subjects are only healthy adults. More than 50% of all test subjects experienced side effects.
21% (3 out of 14) of the high dose group had one to three serious side effects.
The pre-release was less than 100 days after the second vaccination. Medium and long-term side effects are therefore unknown.
We do not know how children, adolescents, seniors, people with pre-existing conditions, pregnant women or generally weakened people will react to the vaccination, since the vaccine was only tested on healthy adults.
We can expect this to be 7 billion people who are supposed to be vaccinated by Bill Gates, the WHO.
Two out of 45 subjects (4%) showed symptoms of Covid 19. This could mean that mass vaccination with this vaccine will continue the alleged pandemic. This would inevitably lead to new pandemic scaremongering with new PCR test epidemics. A neverending story, a perpetual motion machine for everyone who benefits from the corona scaremongering.
It is completely incomprehensible why neither the antibody titers nor the corona infection status were determined in the test subjects before the start of the study. How do you want to determine the “success” of the vaccination?
It is unknown whether the identified measurable immune response is associated with better health, since there are no binding standards for the calibration of these tests and there are already more questions than answers about the informative value of the PCR tests for the detection of a specific infection
Despite these mild and severe side effects, which already occurred in phase 1 of vaccine development in healthy adults, the study authors have no hesitation to conduct further human experiments. In such a phase 1 study with a few completely healthy adults, no side effects should occur at all, because otherwise the extent of the possible damage to health is completely incalculable.
The study also included employees from the Moderna manufacturer. These can be viewed as even less objective than the other contractors for conducting approval studies. How would the side effects have been recorded if you had worked with a real placebo group so that neither test subjects nor study staff knew who belonged to the real and who belonged to the placebo group?
The company EMMES, which has been commissioned with the statistical infrastructure and data evaluation, demonstrably maintains a very close cooperation with the Bill and Melinda Gates Foundation. Not exactly a guarantee for objectivity and openness to results.
A phase 2 study with 600 healthy adults is planned for the summer 2020.
Due to the “robust immune response” in the phase 1 study, Moderna announced just one day after its publication that it would start producing the vaccine and provide up to a billion doses of vaccine within a year. source
The manufacturer Moderna seems to be very sure that its vaccine will receive approval from the FDA if you go into production after a phase 1 has not even been completed.
Tolzin’s opinion: God save us all from this vaccine!
Comment AEC: let’s hope the those citizens who approve of a mandatory Covid vaccination, will lead by example and take it first, so the rest of us can move on.
[Amendment of July 19, 2020]: Another aspect that can cause a considerable bias, i.e. distortion of the results, is the test subjects’ attitude to the vaccine. This can ensure that serious side effects are downplayed or not reported at all. From the point of view of the manufacturer and its partisans, this is of course a strong argument for not using placebo groups. source
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Hans U. P. Tolzin