Moderna is withdrawing its application for U.S. Food and Drug Administration (FDA) approval of its mRNA-1083 combination flu and COVID-19 vaccine, the company announced today — just one day after the FDA said it would require new clinical trials to approve COVID-19 boosters for healthy people under 65.
According to Fierce Biotech, the company will resubmit its application when data from a Phase 3 trial of its mRNA-1010 flu vaccine, which is a component of the combined shot, are available later this year. The company expects to have interim data from the trial available this summer.
Markets reacted negatively to the news, with Moderna’s shares falling 1.4% in premarket trading on Wednesday, The Guardian reported.
According to Reuters, Moderna’s decision to withdraw its application at this time “is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top U.S. health job earlier this year.”
Last week, for instance, the FDA approved Novavax’s new COVID-19 vaccine, but limited its approval to groups that are considered high-risk.
Sayer Ji, co-founder of Stand for Health Freedom and founder and director of GreenMedInfo, said Moderna’s decision to withdraw its application is “telling” and “appears to reflect not only concerns over efficacy but also a growing public skepticism toward hastily developed, multi-antigen formulations that lack sufficient long-term safety data.”
Ji said:
“The withdrawal may be a preemptive move to avoid public scrutiny or regulatory resistance tied to unresolved questions in their clinical data. Combination shots, especially those involving mRNA platforms, introduce compounded risks due to the simultaneous delivery of multiple immunogenic agents.
“These risks are poorly understood and grossly under-evaluated, particularly in vulnerable populations. The immunological complexity of such a vaccine also raises questions about long-term impacts on immune regulation, potential autoimmunity and unintended synergistic effects that could compromise health rather than protect it.”
Hellbound and Down 