On what basis was Moderna C19 injection approved in the first place?

Moderna's own Trials data show that risk-benefit analysis works against it. As usual, the supplementary appendix of the trials publication contains the actual data without the spin.

Out of curiosity, I looked into Moderna’s trials data and the Supplementary Appendix attached to their New England Journal of Medicine (NEJM) publication.

Here is the paper “Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine” updated 4 February 2021

Here is the “Supplementary Appendix” updated 21 January 2021

As usual, the Supplementary Appendix has the actual data which is often missed by media headlines and even some diligent readers.

My focus is on the three things:

1. How many of the vaxxed needed to be medically attended due to a reason caused by the vaccine 28 days post-vaccine?

2. How many of the vaxxed suffer “severe” adverse effects directly caused by the vaccine 28 days post-vaccine?

3. How many of the unvaxxed suffer from “severe” COVID-19?

Trial Population:

There were a total of 30,420 participants in the trial. 15,210 were assigned to receive two doses of the Moderna COVID-19 injection (mRNA-1273,100 μg each dose) and 15,210 were assigned to the placebo arm.

Safety Analysis:

In the Moderna group, 29 participants did not receive any injection. So, this leaves us with 15,181 people in the Moderna group who received at least one injection.

In the Placebo arm, 40 participants did not receive any injection. So, this leaves us with 15,170 people in the Placebo group who received at least one injection.

6 in the Moderna group and 7 in the Placebo group received an incorrect injection.

Of the 6 in the Moderna group who received an incorrect injection, 3 received one dose of Placebo and no dose of Moderna. So they were added to the Placebo group for the purpose of safety study. The other 3 in the Moderna group received one dose of Moderna and one dose of Placebo. Since they received one dose of Moderna, they were retained in the Moderna group for the safety study.

Of the 7 in the Placebo group who received an incorrect injection, all 7 received Moderna and so they were added to the Moderna group for the safety study.

The final number of participants in each group of the safety study is:

Moderna (mRNA-1273): 15,185

Placebo: 15,166.

Unsolicited Adverse Events 28 Days after Injection in the Moderna Trial

The picture above is Table-8 from the Supplementary Appendix. The relevant portions are highlighted in green. The key observations are:

• About 1 in 100 in the Moderna group needed to be medically attended for an adverse event caused by the vaccine.
  

• About 1 in 200 suffered "severe" adverse events directly caused by the Moderna vaccine.

These were determined as related to the vaccine by the study investigators. And the symptoms were determined as “severe” by the investigators. These are not my words.

Since these severe adverse effects were present 28 days after the vaccine, one can conclude that these adverse events are not short-term side effects.

These are some pretty bad numbers. I cannot help but wonder how this product was even given consideration for approval. But the worst is yet to come.

How many unvaxxed got “severe” COVID-19?

To answer the question “How many unvaxxed got severe COVID-19, the study considers the per-protocol analysis. Per protocol analysis includes only those who completed the treatment originally allocated.

Per-Protocol Analysis:

Of the 15,210 participants originally assigned to the Moderna group, 14,134 were included in the per-protocol analysis. In the Placebo group, 14,073 participants were included in the per-protocol analysis.

The breakdown of the numbers is best described in this flowchart from the main paper.

Moderna Trial — Safety Study and Per-Protocol Analysis

COVID-19 symptoms in the vaxxed and unvaxxed groups in the Moderna Trial

The picture above is Table-13 from the Supplementary Appendix. Key points:

• NONE of the participants who received both the doses of Moderna injection suffered from “severe COVID-19”.
  

• 30 out of 14,073 people in the Placebo group got “severe COVID-19.” That is ~0.2%. So, approximately 1 in 500 unvaxxed got “severe COVID-19”.

Note that “All symptoms reported are included, regardless of relationship with the positive RT-PCR test used to define the case of Covid-19”.

Risk-Benefit Analysis:

In order to conduct a very basic risk-benefit analysis of a proposed medical intervention, one needs to consider at least the following:

• What is the likelihood that refusing the proposed medical intervention would lead to “severe” form of the condition, in this case, COVID-19?

• What is the likelihood that undergoing the proposed medical intervention would lead to “severe” adverse effects?

Moderna Vaxxed vs Unvaxxed:

From the sections above, it is clear that:

1. 1 in 100 vaxxed required to be medically attended due to an adverse event caused by Moderna 28 days after the injection.
   

2. 1 in 200 suffered severe adverse effects directly caused by the Moderna injection which persisted 28 days after the injection.
   

3. 1 in 500 of the unvaxxed ended up with one or more severe symptoms of COVID-19.
   

Note:

• The persistence of Moderna-related severe adverse effects 28 days post-Moderna indicates that the adverse effects are not short-term side effects.
  

• The 30 severe COVID-19 cases in the Placebo group were under the condition that they were deprived of Safe, Effective, Cheap, Off-Patent, Life Saving Prophylactic and Early Treatment options. Still, the “vaccine” performs worse than when patients are deprived of early treatment.

All of the above are according to the pharma's own trial data. How does the risk-benefit analysis make any sense? On what basis was Moderna even considered for approval in the first place?

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