Another Moderna booster trial, another death

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Choo Choo

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“O come, let us worship and bow down: let us kneel before the LORD our maker.”  Psalms 95:6 (KJV) 

Participants in Moderna’s clinical trials for its mRNA booster Covid shots keep dying.

And Moderna keeps obscuring their deaths.

Last week, Moderna disclosed a death in its newest booster trial in a single chart on page 49 of a 53-page report, while elsewhere in the report inaccurately claiming the trial had “no fatal events.”

Today, a reader pointed out another death in an earlier Moderna booster trial, this one from cardiac arrest in a 72-year-old man. The victim had received his third or “booster” dose nine days before.

The death appears to have occurred in August 2021, at least six weeks before the Food and Drug Administration held a hearing in October to discuss authorizing a Moderna booster at a dose lower than the one used in the August trial.

But the death was not mentioned at the hearing.

Instead, Moderna quietly disclosed the death last month in a report on the trial it published on a “preprint” server. Almost no one appears to have seen the report. The full-text version of the report, where a description of the death can be found, had been viewed online fewer than 70 times as of this morning.

The report also discloses a stroke suffered by another participant in the trial.

Of note, both victims were men in their early seventies, although only about 50 of the trial’s 305 participants were men over 65. The stroke occurred only four days after the booster mRNA dose.

The company said that its investigators believed the booster had caused the stroke but not the cardiac arrest; it did not offer details as to how they had reached that conclusion. No outside investigators appear to have reviewed either case.

Moderna began the trial, which it called Study P205, on August 3, 2021 to test a 100-microgram mRNA booster dose. That dosage equivalent to the amount of mRNA used in the original two shots, and more than three times as high as the mRNA Pfizer and BioNTech used in their shot.

Moderna had already tried a smaller 50-microgram booster dose in a booster trial that began in the spring of 2021.

But by midsummer 2021, data from Israel and Britain had shown that the mRNA shots were failing, especially against the then-common Delta variant. The company hoped a more powerful dose might lead to more anti-spike-protein antibodies and stronger protection against Sars-Cov-2.

Between August 3 and August 16, clinical trial investigators enrolled 305 people in the 100-microgram trial. All had been part of Moderna’s pivotal 30,000-person clinical trial that led to the original approval of the two-dose regimen, and all had received two doses.

The 100-microgram booster did produce more anti-spike protein antibodies than the 50-microgram dose had in Moderna’s first booster trial. But it also produced more side effects than the lower dose- and more side effects than even the second dose of the original regimen.

In the trial report, investigators appeared concerned about the level of side effects and mentioned them in the first sentence of the results. They suggested the 100-microgram dose be considered only “when eli…

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