Healthy Child’s Death in Moderna Omicron Booster Trial Concealed

A child died in the Moderna clinical trial for the COVID-19 Omicron booster, but it was never included in the American clinical trial data by the company. Journalist Alex Berenson reported about a child under the age of five who passed away at the end of 2022 or the beginning of 2023 while Moderna was conducting clinical trials for the “1273.214” Omicron booster. Berenson first reported this last week on his Substack and released part two yesterday, which breaks down the methods the company used to cover up the death.

Berenson found the complete clinical data for the KidCOVE trial on a European drug regulatory database. European regulators required Moderna to publish the data in September, otherwise the death of a healthy child would still be unknown to the public. Berenson also pointed out higher rates of other serious side effects in the vaccinated group. 99 out of 8,000 (1.24%) in the vaccinated group had serious side effects compared to 10 out of 2,700 (0.37%) in the placebo group. Berenson said, “In almost every case,” Moderna concluded the side effects were unrelated to the vaccine.

The child’s cause of death was listed as “cardio-respiratory arrest.” Moderna determined the death was not caused by the vaccine in the clinical trial but did not provide details on how they reached that conclusion. Additionally, they did not publish enough information for an independent assessment.

Myocarditis is one condition that can cause “cardio-respiratory arrest,” which is connected to the mRNA vaccines. Berenson said there are important details that Moderna knows but hasn’t disclosed. This includes whether or not the child had underlying conditions and the length of time between the injection and the child’s death.

In the U.S., companies are required to post clinical testing results to the database at clinicaltrials.gov. The National Library of Medicine, a division of the NIH, operates the database. Berenson received a statement from a spokesperson who said it is Moderna’s responsibility to post the results, not the federal government. She was unsure of when Moderna would post this clinical trial data or the consequences of not doing so.

While Moderna hasn’t published the full clinical trial data in the U.S. as it did in Europe, the company did publish a paper with KidCOVE clinical trial data. The paper included older children who had received the original mRNA-1273 vaccine rather than the updated Omicron booster. The paper didn’t include the younger children who received the Omicron booster, so the death was not reported.

Moderna published data on a ROVER trial that included 539 young children who were moved from the KidCOVE trial. These children received the 1273.214 Omicron booster, but no children died in this small trial.

Berenson wrote, “By reporting the ROVER trial findings along with the partial KidCOVE data for older children, Moderna effectively made the death of a healthy young child in its clinical trial disappear. Unfortunately, making the death disappear is not the same as making it not happen. With Moderna and public health authorities still pushing Covid jabs on healthy kids at essentially zero risk from the virus, perhaps Dr. Creech or someone at Moderna will decide to tell us what really happened to the child who died.”

Pharmaceutical companies must legally report any deaths during clinical trials to the FDA. It is not clear whether Moderna quietly reported this death to the FDA or failed its legal obligation to do so. Moderna did not respond to Berenson’s request to comment about the clinical trial death. The FDA only said “no deaths [were] reported” in the trials “that were the basis of the Emergency Use Authorization.”

The FDA used KidCOVE clinical trial data as the basis for the EUA, but the authorization was approved before the child died. The FDA’s statement is unclear because no deaths were reported at the time of the EUA. It is unknown if Moderna fulfilled its legal requirement by reporting the death to the FDA or whether the FDA knew about the child’s death. Berenson said the FDA did not respond to follow-up questions.

Berenson pointed out the ineffectiveness of the Omicron booster for children stating they provided “short-term protection of only about 40 percent among young kids.” That is significantly lower than the protection they provided adults. The risk of COVID-19 infection and serious side effects were also very low for children, but the mRNA vaccines are recommended annually for all children over 6 months of age. The U.K. has stopped providing COVID-19 vaccines for anyone under 65 who isn’t considered “high risk.”

The HighWire has reported other concerns related to COVID-19 vaccines during the Pfizer and AstraZeneca clinical trials. The FDA requested 75 years to provide Pfizer’s clinical trial data, but a judge ordered the release of the documents after ICAN won the lawsuit. Journalist Naomi Wolf took this data and wrote The Pfizer Papers. She appeared on The HighWire to discuss the revelations.

A landmark lawsuit is underway against AstraZeneca for breach of contract, which involved not providing financial assistance to Brianne Dressen, who was vaccine-injured during the clinical trial.