Another Moderna booster trial, another death

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.

SOURCE

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 eliciting an antibody response might be challenging such as in moderately or severely immunocompromised hosts.”

Ultimately, Moderna did not ask the FDA to authorize a 100-microgram booster shot.

Instead, on Sep. 1, it asked for a 50-microgram booster. In the hearing on Oct. 14, it presented data from the spring 2021 booster study, called 201B. That study included only 171 people who had received a 50-microgram booster after the 100-microgram primary regimen. It reported no deaths or severe adverse events, according to data the FDA presented to an advisory panel on Oct. 14.

The FDA panel voted unanimously to recommend the 50-microgram Moderna booster for immunocompromised people or people over 65. In late November, the FDA extended booster authorization to all adults.

But a booster dose has proven no more effective than the first two at providing lasting protection against Covid.

Thus, on March 29, the FDA authorized a second 50-microgram booster dose - as well as a second Pfizer booster dose - for adults over 50.

To justify its recommendation, which will lead to adults receiving the equivalent of the 100-microgram dose that caused the stroke in the August trial, the FDA relied on safety data from Pfizer’s vaccine - a different product administered at a lower dose - as well as

an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety concerns were reported during up to three weeks of follow up after the second booster dose.

Yes. You read that right.

Even though Moderna’s scientists themselves acknowledge that the company’s mRNA shots have a dose-dependent toxicity, the FDA told over 100 million Americans they could take yet another jab based on a study that covered 120 people. And followed their safety for three weeks.

What could go wrong?