Moderna buried child's death in COVID booster trial in EU report, FDA response called 'misleading'

President Joe Biden bestowed the National Medal of Technology and Innovation on a vaccine maker that allegedly hid a child's death in a COVID-19 clinical trial from Americans, and the Food and Drug Administration may have known about the purported subterfuge.

Moderna apparently only disclosed the death from "cardio-respiratory arrest," which it asserted without evidence was not related to the child's jab, in the European Union Clinical Trials Register Sept. 30, six months after its trial on "healthy children" 6 months-12 years ended, but not in publicly accessible U.S. system ClinicalTrials.gov as legally required.

It's just the latest bad news for the lower-profile mRNA vaccine maker, which is already reeling from a stock that tanked in 2024 in part from falling COVID vaccination rates and closed down another 5% the day President-elect Donald Trump nominated vaccine-skeptical Robert F. Kennedy Jr. as Health and Human Services secretary. 

The FDA was already scrutinizing Moderna's RSV pediatric vaccine trial, paused without explanation this past summer, because infant recipients developed lower-respiratory-tract infections. The agency waited until last month to disclose the finding, which was only made possible by a placebo group – an unusual trial design choice for childhood vaccines.

But it's also a potential black eye for U.S. regulators, who are financially entangled with Moderna's COVID vaccine. 

The company in 2023 paid the National Institute of Allergy and Infectious Diseases a $400 million lump sum, and "low single-digit royalties" going forward, to use technologies allegedly invented by government researchers. The U.S. feathered its own bed by approving an updated Moderna booster last summer.

CEO Stéphane Bancel gave investors a rosy assessment Monday, saying Moderna's R&D investments for the next three years "will potentially yield up to 10 product approvals" and bragging it was the only maker with "more than one approved mRNA product."

Former New York Times drug industry reporter Alex Berenson flagged the child's death Friday, the same day Biden honored Moderna and Pfizer because their "vision, intellect, creativity, and determination have strengthened America’s economy and improved our quality of life."

Berenson said Sen. Ron Johnson, R-Wis., told him that he plans when the GOP takes Senate control this month and he assumes sweeping subpoena powers as chair of the Permanent Subcommittee on Investigations to subpoena the FDA for what it knew.

Last fall Johnson alerted FDA Commissioner Robert Califf and Centers for Disease Control and Prevention Director Mandy Cohen of Czech data that he said show Moderna's COVID vaccine, licensed as Spikevax, "increased all-cause-mortality (ACM) over a 12-month period from the time of vaccination for every age."

The FDA gave Berenson a curious response that he shared in full with Just the News, saying there were no deaths "reported" for minors in the Moderna trials "that were the basis" for its emergency use authorization. 

The spokesperson pointed to a July 1, 2022, "Decision Memorandum" signed by Center for Biologics Evaluation and Research Director Peter Marks, known for his foppish "Just a Minute" social media videos and promising Congress he wouldn't reject a pediatric COVID vaccine with under 50% efficacy.

See the agency's full statement to Berenson here:

Moderna's European report, however, says the death happened after Emergency Use Authorization, with a reformulated version of its vaccine identified as "mRNA-1273.214" that started testing Aug. 4, 2022. The report describes it as an "optional … bivalent (Omicron containing) adaptation of the original" vaccine, offered to participants who didn't already get a booster after the primary series.

"The FDA’s statement is either intentionally misleading, factually incorrect, or both," Berenson wrote Monday, noting the FDA didn't refer to the fact of the child's death in the KidCOVE trial but instead the trial data that Marks evaluated for EUA, as the trial continued. He told the FDA its "carefully worded statement" was "factually correct but essentially untrue."

The FDA was not able to give Just the News a response by deadline to a request for clear, unambiguous language on what it knew and when about a child's death in the Omicron bivalent trial and what penalties Moderna could face for not reporting it to ClinicalTrials.gov.

Boston-based Moderna did not answer queries to its media or clinical trials departments about its alleged shenanigans.

The death is buried in a pair of tables in Moderna's Europe report.

The first is called "Number of subjects in period 2," defined as the "Booster Dose (BD) Phase." One "Adverse event, serious fatal" occurred in "Part 2" among 2,261 children, ages 6 months-5 years, who received a 10-microgram booster after receiving a 25-microgram primary series. 

The "Serious Adverse Events" table, several scrolls further down the page, says one person in the same phase, part, dose and age suffered cardio-respiratory arrest – when both heart and lung function suddenly halt – but neither the occurrence nor the death was "causally related to treatment," with no further explanation of how Moderna knew the jab wasn't a cause.

(While the second table shows a different number of children – 2,771 – both appear to be the only columns between the two tables that show a death.)

U.S. disclosure is required under 2017 regulations, which a federal court in 2020 extended retroactively to 10 years of federally funded trial results on the basis that the National Institutes of Health – led by Francis Collins from 2009 through the first year of COVID vaccines – had misread reporting requirements in the FDA Amendments Act of 2007.

An investigation by STAT in 2015 found that most institutions "routinely" flout the law, with on-time compliance peaking at 38% in 2013 and some of the biggest recipients of federal largesse – Stanford, University of Pennsylvania, University of Pittsburgh and University of California San Diego – missing at least the deadline 95% of the time.

Science reported in 2020, just a month before the court ruling, that FDA and NIH were doing "little to nothing" to enforce the rules – never having fined a trial sponsor or withdrawn a grant, much less publicly named a violator – and that NIH's "top institutes for clinical trials have a poor record of reporting results of those trials for which they are responsible."

That disclosure lawsuit was brought in part by former FDA Associate Commissioner Peter Lurie. He spoke up last year when FDA ethics guidance emerged that showed employees who accepted Moderna job offers after reviewing its COVID vaccine were told they could legally work "behind the scenes" to influence the agency's treatment of their pending employer.

"During clinical trials, study sponsors (vaccine manufacturers, clinical investigators, etc.) are required to report serious adverse events to the FDA," the spokesperson told Berenson. 

"This includes unexpected fatal or life-threatening suspected adverse reaction reports, for which sponsors must notify the FDA as soon as possible, but no later than 7 calendar days after the sponsor’s initial receipt of the information," the statement reads, without mentioning Moderna's alleged withholding of that information at least stateside.