Moderna has abruptly withdrawn its bid for FDA approval of its experimental COVID-flu combination vaccine, triggering fresh concerns about transparency and safety.
The move came only after the FDA made a basic request: show the data proving the shot is both safe and effective. Moderna couldn’t deliver.
The biotech giant—catapulted to notoriety during the pandemic through emergency authorizations and unproven mRNA technology—admitted Wednesday it lacks the necessary efficacy data to justify approval.
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Instead, the company now says it will try again later this year, pending results from an ongoing late-stage trial of its still-unapproved seasonal flu shot.
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Why submit a vaccine for approval without basic efficacy data? Why rush it to market for adults 50 and older without proof it actually works—or is safe?
The timing of the withdrawal couldn’t be more suspicious. It comes just one day after the FDA announced that annual COVID-19 boosters for healthy adults under 65 would require fresh clinical trials—a significant departure from the rubber-stamping of years past.
Moderna’s financial situation isn’t helping its credibility. With COVID vaccine profits plummeting and investor confidence shaken, especially after Robert F. Kennedy Jr. was appointed Secretary of Health and Human Services, the company is desperately chasing new revenue streams. That desperation shows.
Its stock has already taken a brutal beating, falling nearly 60% over the past year. The latest stumble saw another 1.4% drop in pre-market trading on Wednesday.
Despite the setback, the FDA is still expected to rule by the end of this month on Moderna’s so-called “next-generation” COVID vaccine, which would form the backbone of the combo shot. But internal delays have already pushed the timeline for full approval of the combined injection to at least 2026.
The question no one in mainstream media is asking: Why are we being rushed into multi-disease injections, based on a platform still riddled with unanswered questions—especially when early warning signs point to serious adverse effects and declining trust from the public?
With a track record built more on aggressive lobbying and emergency powers than long-term safety data, Moderna’s latest move looks less like science—and more like damage control.