Seven things wrong with the Moderna mRNA-1283 SARS-CoV-2 Vaccine Phase 1 Trial

Note: I added another reason why this study is flawed. When first published, it was six. Now there are seven things wrong with the study.

This article critically examines the Phase I clinical trial of the Moderna mRNA-1283 SARS-CoV-2 Vaccine for Adults.

The mRNA-1283 is the new booster shot for COVID-19. It has shown its effectiveness before on eight mice.

The trial was published yesterday, October 19, 2022, as a preprint at medRxiv. Moderna funded the study, and therefore you can see from a mile away that the conclusion will be that the new Moderna shots mRNA-1283 will be “safe and effective.”

Before you get drawn to the same ideas that the mainstream and social media will parrot, it is good to make your conclusions based on the study’s data. In this article, I present my own.

Keep in mind that this study will be presented to the US FDA. Therefore, designing the study population well is critical to show the new mRNA-1283 will be “safe and effective.”

Other countries will also follow the US FDA approval. Thus billions of dollars rest on the results of this study. Furthermore, hundreds of medical articles will also cite this Moderna study.

We will look at this the reasons why the conclusion that the Moderna mRNA-1283 is “safe and effective.”

I will discuss below the nuances and significance. See if you can find what is wrong with the data below.

Source: Yassini et al. medRxiv 2022.10.18.22281050

The study says that it is safe for adults. But what adult? Let’s look at the study population.

1. No one older than 60 is included. Why?

The average age range is relatively young, at 33-38 ± 10.4. The older population (50 and older), who are the targets of the shots, is not included. Why?

Less robust immune response

Older people don’t have a robust immune response as younger people do and will not develop high levels of neutralizing antibodies.

Original antigenic sin

Another reason is that older people have the “original antigenic sin,” also known as immune imprinting.

The original antigenic sin means that the antibodies a person will make against a newer variant of a virus, e.g., the Omicron, will be directed against the first variant the person encountered in their younger days. That variant can be any of the common human coronaviruses endemic in the population. That means exposure to the Omicron will show elicit antibodies against the endemic coronaviruses and not to the Omicron.

More about immune imprinting in What is Immune Imprinting and why it is good to know.

No elderly people means fewer adverse events

Pre-existing medical problems like cardiovascular diseases make the elderly more likely to develop serious adverse events like heart attacks and strokes after being injected with an experimental “vaccine.”

A study published in the Frontiers of Medicine, Age and Gender Disparities in Adverse Events Following COVID-19 Vaccination: Real-World Evidence Based on Big Data for Risk Management, showed that

Compared to younger adults aged between 18 and 64 years, older adults were more likely to report serious adverse events, death, permanent disability, and hospitalization.

2. Fewer females than males

Women are expected to have more adverse events because they are more prone to autoimmune diseases. That is why fewer females are in the higher dose group (30-100 µg). The group with more females is in the lowest dose group of 10 µg.

The image of the sex distribution below is from the larger image above with the doses.

The lower number of females in the higher dose group makes it more likely that there will be fewer adverse events and the dose of the shots will be “safe.”

Lower doses for females make it more likely to have fewer autoimmune-related adverse events. In the lower dose of 10 µg, they put more females (12) than males (9).

More females in the lower dose allow the total number of females to increase in the whole study group, giving the impression that the genders are well represented in the study.

3. Not all races are represented equally

There are more Whites than Blacks, Asians, American Indians or Alaska Natives, Native Hawaiian or Pacific Islanders, and other groups.

That is why any conclusion in this study should not apply to races other than Caucasians.

4. No obese people included

Obesity is defined as a BMI of more than 30. According to the CDC, as of March 2020, the obesity prevalence is 41.9%.

Obesity is a significant risk factor for developing severe COVID-19. They are more prone to develop heart disease, stroke, and type 2 diabetes, making them more likely to develop adverse events from mRNA shots.

The BMI in the study is limited to the Overweight category of 25-29.9.

Source: Yassini et al. medRxiv 2022.10.18.22281050

Therefore, the study conclusions should not apply to people with obesity. The same people are at risk for severe COVID-19 and are targeted for mRNA shots.

5. Adverse Events: All symptoms, no diagnosis

In their discussion, the study said that most adverse events are mild to moderate (Grades 1-2). However, we can see that there are severe reactions, too (Grade 3).

The described systemic adverse events were limited to symptoms: joint pains (arthralgia), muscle pains (myalgia), fatigue, headaches, and fever.

But what caused the symptoms? What is the disease causing the symptom? Are the joint and muscle pains because of an autoimmune reaction to the cartilages and skeletal muscles?
The SARS-CoV-2 spike protein cross-reacts with eleven human proteins to cause autoimmune diseases

Is the fatigue due to a lower cardiac ejection fraction from an inflamed heart with myocarditis?

Are the headaches from a beginning cavernous sinus thrombosis?

I’m not saying that the participants had myocarditis or strokes. I am saying there should have been more testing to determine the cause of the adverse events.

6. The duration of antibodies is briefly studied

The majority of the antibody studies were done on the Wuhan-Hu-1 spike protein. The first coronavirus that came from Wuhan, China That variant is now clinically extinct. Do you know anyone who has had the Wuhan variant lately?

The Wuhan spike protein has mutated several times with the Omicron.

Some antibody studies were done against Omicron B.1.351, which shows an increase in the antibody titers up to day 57.

Why only up to 57 days?

That’s because a previous study published in the New England Journal of Medicine shows that antibody levels elicited by the Moderna shots start to decline after 57 days.

Source: N Engl J Med 2021; 384:80-82 DOI: 10.1056/NEJMc2032195

I discussed the waning antibodies of the mRNA shots at:

7. Surrogate endpoints were used

The study did not prove that mRNA-1283 prevented anyone from getting COVID-19. They used the presence of neutralizing antibodies in the blood instead of following the study groups to see if the shots prevented COVID-19 or whether the new booster shots would prevent hospitalization and deaths.

Using surrogate endpoints is a common trick by big pharma to show that their new drugs work.

In summary, Moderna designed the study group to minimize adverse events. In doing so, they excluded the elderly and the obese, at risk for severe Covid-19.

The adverse events were minimized by reporting symptoms and not diagnosis.

With regards to effectiveness, they tested it against a clinically irrelevant SARS-CoV-2. Moreover, the antibodies elicited are only food for less than two months. Taking this booster makes you susceptible to Covid-19 again after two months.

And we’re not even talking about the severe adverse events.

Lies kill. Truth heals. Don’t Get Sick!

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Reference:

Yassini et al. Interim Analysis of a Phase I Randomized Clinical Trial on the Safety and Immunogenicity of the mRNA-1283 SARS-CoV-2 Vaccine in Adults. medRxiv 2022.10.18.22281050
Widge et al. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med 2021; 384:80-82 DOI: 10.1056/NEJMc2032195