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.
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