(PART 1: A CHILD’S DEATH)
A preschool-aged child died of cardio-respiratory arrest after getting a booster shot of Moderna’s mRNA Covid vaccine in the company’s main clinical trial of the jab.
The death occurred about two years ago. Moderna has not apparently reported it in any preprint or scientific journal. Nor has the company disclosed the death on clinicaltrials.gov, a federal site where companies legally must report trial results.
In fact, Moderna has reported findings from the trial, called KidCOVE, and a related trial in a way that effectively hides the death. And the company and government still push mRNA Covid jabs on kids, though many studies show they are of little or no use.
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(The truths you need. The truths they don’t want you to have. Help me find them.)
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If and when the company secretly told the Food and Drug Administration of the death - as it is legally required to do - is unclear. So is the agency’s response. The fact sheets the FDA and other national regulators use to describe the risks and benefits of Moderna’s vaccines for children do not mention the death.
Moderna did not respond to questions. Asked about deaths in the KidCOVE trial, the FDA released a statement that appeared worded to avoid confirming the death and did not disclose what, if any, actions the agency had taken in response.
In its statement, the FDA said only that “no deaths [were] reported” in the trials “that were the basis of the Emergency Use Authorization” of the shot for children in 2022. In fact, the KidCOVE trial was the basis of the authorization, though the death occurred after the authorization. The agency did not answer follow-up questions.
Moderna appears to have publicly disclosed the death only in an obscure database run by the European drug regulatory agency. The database offers the only full public safety results from KidCOVE, which included 11,942 children and ended in March 2024. Moderna claimed the death was unrelated to its vaccine, but the filing does not provide enough facts for an independent assessment.
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(Adverse event, serious fatal)
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The death occurred in late 2022 or early 2023, when children under 5 who had already received Moderna’s original mRNA-1273 vaccine in the trial’s main phase were offered a shot of its “1273.214” booster against an early Omicron variant.
The original mRNA vaccine formulations had not worked well against Omicron in children or adults. Moderna hoped to show that updated jabs that made the body produce a Omicron spike would protect better against Omicron. Because this portion of the trial did not include a placebo-blinded arm, the company would have known immediately that the death followed vaccination.
Moderna’s report to regulators lists the death as resulting from “cardio-respiratory arrest” - a sudden failure of the heart to beat.
Many underlying factors can cause cardiac arrest, including myocarditis, or heart muscle inflammation, which the mRNAs can cause, particularly in young people. But Moderna reported the death was unrelated to its vaccine. The company did not disclose in the report how it had reached that conclusion.
Moderna did not respond to a request for comment on the trial or its failure to publish the results.
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(Cardio-respiratory arrest. Note Moderna’s claim that the death is not “causally related to treatment.”)
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Moderna completed the KidCOVE trial on March 15, 2024, and finished its analysis of the results on May 17, according to the report it filed with the European Union’s Clinical Trials Register. It published the report on the register on September 30.
But it still has not posted the report at clinicaltrials.gov, the federal Website where drug and vaccine companies are required to post information about ongoing trials and results from completed trials.
A spokesperson for the National Library of Medicine, the unit at the National Institutes of Health that runs clinicaltrials.gov, said Moderna, not the government, is responsible for posting results. She added she did not have information about when Moderna might post them or what penalties it might face for failing to do so.
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Moderna began the KidCOVE trial in March 2021, following the apparent success of its earlier COVE clinical trial for its mRNA Covid vaccine in adults 18 and over.
At the time, after a year of media scaremongering about Covid’s dangers to children, many parents were clamoring for Covid shots for kids. In addition, public health authorities pushed the theory that jabbing kids would protect vulnerable adults.
The trial was initially supposed to include 6,750 children in the United States and Canada, but Moderna later nearly doubled its size. The company enrolled about 4,000 older kids and 6,500 infants, toddlers and preschoolers in the trial’s main phase. Three out of four received the jab, while the rest received a placebo - shots of saline solution.
In October 2021, Moderna announced that the trial had succeeded for kids 6-11, and in March 2022 for kids 6 months to 5 years old.
Still, the vaccine offered short-term protection of only about 40 percent among young kids, making it much less effective even in the short run than it had been in older people. It was unclear if the failure occurred because younger children’s immune systems function differently, because Omicron escaped vaccine immunity, or both.
In any case, public health authorities, Moderna, and Pfizer quickly pressed mRNA vaccines on children, with the media’s eager assistance.
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(What’s cardio-respiratory arrest, Elmo?)
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The full trial safety results in the European report, also not previously reported, show problems that go beyond the death. Kids who received the Moderna mRNA vaccine were much more likely to have serious side effects than placebo recipients.
Overall, 99 out of about 8,000 children under 12 who received the vaccine in the trial’s main phase had serious side effects. Only 10 of about 2,700 who received saline did.
In almost every case, Moderna waved aside the side effects, reported they were unrelated to the shot. For example, six children aged 2-5 reported severe respiratory symptoms following the jab. None who received placebo did. The company claimed none of those events were related to its jab.
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(The truth, now and always.)
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By now, the failure of the Covid vaccines against Omicron, the fact Covid almost never seriously harms healthy children , and questions about the long-term impact of the mRNAs have caused parents to reject further shots for their children. Even in blue New York state, under 3 percent of kids and teenagers have received the shots.
Still, the mRNAs may be dead for kids, but the scrutiny that health authorities and vaccine companies are facing over the safety of childhood vaccines is rising.
The fact that neither Moderna nor the FDA informed the public of the death of a child during a clinical trial will do little to increase parental trust.
(END OF PART 1. IN PART 2: HOW MODERNA FRAMED THE CLINICAL TRIAL RESULTS IT PUBLISHED SO IT WOULD NOT HAVE TO REPORT THE DEATH.)