The FDA has rejected Moderna’s request for authorization of an innovative mRNA flu shot, pointing to insufficient testing in clinical settings. The regulator voiced misgivings regarding comparisons of the vaccine against “the prevailing standard of care currently utilized in the United States.”
The United States Food and Drug Administration (FDA) is declining to assess Moderna’s submission for a novel influenza vaccine utilizing Nobel Prize-recognized mRNA technology, UNN indicates, referencing the Associated Press.
Details
The declaration represents further validation of the FDA’s heightened examination of vaccines under the direction of Secretary of Health and Human Services Robert F. Kennedy Jr., especially those employing mRNA technology, which he critiqued both before and following his appointment as the nation’s foremost health authority.
Moderna was issued a “rejection of registration” notification from the FDA, which articulated concerns regarding the undertaking of a clinical trial involving 40,000 participants, where the novel vaccine was contrasted with a contemporary standard influenza vaccine. The aforementioned trial determined that the new vaccine demonstrated marginally superior efficacy in adults aged 50 years and over when juxtaposed with the standard vaccine.
– says the Associated Press publication.
In parallel, correspondence from FDA Vaccine Director Dr. Vinay Prasad conveyed that the agency did not deem the application to include a “sufficient and adequately managed trial” due to its omission of a comparison between the new vaccine and “the prevailing standard of care currently utilized in the United States during the study.” Prasad’s communication also alluded to specific directives that FDA representatives imparted to Moderna in 2024 during the Biden administration, yet which Moderna opted not to heed.
The stipulations additionally stipulated that while employing the conventional dosage of the flu vaccine selected by the company was deemed permissible, utilizing a disparate brand of vaccine explicitly endorsed for older individuals would be more apt for study participants aged 65 and beyond. Nonetheless, Moderna asserted that the FDA had concurred to permit the study to proceed in accordance with its originally formulated design.
We will remind you
US President Donald Trump previously formalized an executive decree prohibiting financial support for investigations into function augmentations that amplify pathogens.
Simultaneously, WHO member nations have crafted a consensus on allocating medical technology to adequately prepare for prospective pandemics. The accord will foster technology dissemination, albeit subject to terms of reciprocal agreement.