Concerns about the safety and efficacy of mRNA COVID-19 shots have increased after a January 3 report that drug maker Moderna failed to inform the U.S. government of the death of a child during clinical trials of its vaccine, as required by law.
“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,” former New York Times reporter Alex Berenson wrote on Substack.
Instead of disclosing the death to clinicaltrials.gov, a federal government website where companies must legally report trial results, Moderna posted the incident on “an obscure database run by the European drug regulatory agency,” wrote Berenson.
The child died in late 2022 or early 2023, Berenson reported.
Government, Media Push
Moderna launched its KidCOVE clinical trial in March 2021 after the success of its original mRNA COVID-19 vaccine in adults 18-years-old and over. Pressure from public health authorities and the media had been building for some time to vaccinate children against the coronavirus, although mounting evidence showed the very young were at little risk of contracting the disease.
With the emergence of the Omicron variant contracting or spreading COVID-19 in November 2021, Moderna and other vaccine companies developed boosters, which Moderna included in another phase of its child trial.
“Because this portion of the trial did not include a placebo-blinded arm, the company would have known immediately that the death followed vaccination,” wrote Berenson.
Moderna’s report to regulators lists the death as “cardio-respiratory arrest,” not related to the vaccine, and did not explain how the company came to that conclusion, Berenson wrote.
Moderna has made no public comment about the death as of this writing.
FDA Reliance on Reporting
Before the death of the child, Moderna announced in October 2021 its trial had succeeded among children ages six through 11-year-olds, and in March 2022 for children six months to five-years-old. The Food and Drug Administration (FDA) then issued an Emergency Use Authorization (EUA) for the company’s booster for kids.
Now that the post-vaccination death of the child has finally been reported to an overseas database, the FDA will be under pressure to explain its failure to disclose the fact.
“In its statement [responding to Berenson’s email questions before publication on January 3], the FDA says only that ‘no deaths [were] reported’ in the trials ‘that were the basis of the Emergency Use Authorization’ for the shot for children in 2022,” wrote Berenson. “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.”
Berenson reported on January 6, Sen. Ron Johnson (R-WI) plans to subpoena the agency to find out what it knew and when.
Lack of Informed Consent
Moderna’s actions raise a huge red flag, says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“It appears that Moderna seriously violated a clear federal law by failing to properly report a child’s death in an experimental trial,” said Orient
Reporting the death could have affected the EUA, Orient says.
“[The FDA] might well have withdrawn the EUA, especially since Omicron was not an emergency, especially for children,” said Orient. “The EUA requires informed consent, and it is doubtful that parents would have consented knowing that a child had died of a cardiorespiratory arrest, a highly unusual event in a previously healthy child, after getting an experimental shot.
“The problem is not just this product, but the company and the regulatory process itself,” said Orient. “Dr. Makary should immediately act on this.”
Calls for a Ban
Peter A. McCullough, M.D., a Dallas-based cardiologist, says the mRNA vaccines should be withdrawn.
“As a medical doctor, I am greatly concerned that children in some states are effectively forced to take COVID-19 vaccines as part of the routine schedule required to attend schools,” said McCullough. “One death after Moderna’s COVID-19 vaccine is one death too many, as almost all children have had the infection once and recurrent illnesses are no different than the common cold.
“I support the World Council for Health, the American Association of Physicians and Surgeons, and many other leading figures in health care in calling for immediate removal of all COVID-19 vaccines from human use,” said McCullough.
Bonner Russell Cohen, Ph.D., ([email protected]) is a senior fellow at the National Center for Public Policy Research.
Bonner R. Cohen is a senior fellow with the National Center for Public Policy Research, a position he has held since 2002.
