By John Q. Hosedrinker 
The Food and Drug Administration (FDA) has refused to review Moderna’s experimental flu shot, mRNA-1010, citing issues with the study design despite previous agency approval. Moderna stated the FDA did not identify any safety or efficacy concerns and plans to meet with the agency to discuss a path forward. This decision, which contrasts with prior feedback, occurs amidst broader shifts in U.S. vaccine regulation influenced by prominent vaccine skeptic Robert F. Kennedy Jr. and the return of FDA vaccine regulator Vinay Prasad, who has advocated for tighter vaccine rules. Despite this setback, Moderna’s stock saw a slight dip, but the company expects approval for its flu shot by late 2026 or late 2027, pending international reviews.
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It seems there’s a significant kerfuffle involving Moderna and the FDA concerning an experimental flu shot. Moderna is reporting that the FDA has refused to even review their application for this new flu vaccine. This is quite a development, especially considering the immense resources, reportedly around $2 billion, that go into developing a new drug.
The sentiment expressed is that this refusal isn’t based on scientific data or the merits of the vaccine itself. Instead, there’s a strong feeling that the decision is being driven by ideological conflicts and what’s being called “culture war bullshit.” This is a pretty harsh accusation, suggesting that broader political or social agendas are overriding the scientific process.
This situation is raising serious concerns about the future of drug development in the United States. The implication is that if promising new treatments and preventative measures are not even being considered due to non-scientific reasons, the entire industry could suffer immensely. Some are even going so far as to say America is “speed running third world status” due to such perceived governmental failings.
Given these developments, some individuals are re-evaluating their investments in the biotech sector altogether. The trust in the U.S. government’s ability to handle public health matters appears to be eroding significantly for these individuals, to the point where they might trust a drug company more than the government. This is a stark statement, highlighting a deep disillusionment.
There’s a palpable sense of urgency for better flu vaccines, and this refusal feels particularly “petty” to some. The question arises: is this an example of the government actively making policies that lead to people getting sick or even dying? The idea that “letting people die is the new policy” is a deeply concerning one, and it’s being linked to the current administration’s leadership in health and human services.
Speculation is also rife about potential motivations behind the FDA’s decision. Some are suggesting that if the applicant were Pfizer, which has been a major supplier of medications, or if there were political donations involved, the outcome might be different. The suggestion that companies might need to “donate to the ballroom,” or that bribery is involved, points to a cynical view of how such decisions are made.
The conversation then turns to the possibility of vaccine tourism. With the U.S. government seemingly creating obstacles, other countries, like Canada, are being suggested as welcoming havens for pharmaceutical companies and individuals seeking advanced medical treatments. This highlights a potential brain drain and a loss of leadership for the U.S. in crucial areas like vaccine development.
The frustration is so high that some are making sarcastic suggestions, like telling the FDA it’s “horse medicine” to get it reviewed, referencing a popular, albeit controversial, treatment. This underscores the feeling that rational processes are being abandoned.
A key point of contention is Moderna’s proven track record. The reminder that this is a company that “pulled a covid vaccine out of their ass in record time to save the world” emphasizes the perceived contradiction in their current situation. Why would a company with such demonstrated capability in rapid vaccine development face such an impasse?
There’s a strong desire to understand the FDA’s perspective, especially given the current administration’s perceived lack of “common sense” regarding vaccines. This questioning of the administration’s credibility on vaccine matters is a recurring theme.
The ultimate question driving much of this discourse is “Why do they want more of us to die?” This sentiment reflects a deep-seated fear and confusion about why a public health agency would seemingly hinder progress in developing better health tools. The idea of launching a “vaccine tourism travel service” is born out of this frustration, offering a way around perceived governmental roadblocks.
Some believe the issue is purely ideological, linked to what’s termed “MAGA’s lame ass culture war,” which they feel is setting the country back significantly. Others, however, suspect more clandestine motives, such as the need for bribes, or that the current political climate favors keeping people “poor sick and uneducated” for easier manipulation.
The notion of a “bribe” is repeated, with some sarcastically suggesting that “the right amount of money to the right person” is the key, even naming Donald Trump as a potential recipient. This points to a deep distrust in the integrity of the political and regulatory process.
There’s a broader concern that these actions are “small steps towards eugenics,” and a general feeling of embarrassment about the state of the country. This sentiment is so strong that some are even expressing disinterest in national celebrations due to their disillusionment.
The refusal to even review the application upfront is seen as particularly baffling and “anti-science.” The suggestion that California might review it shows a lack of faith in federal institutions. The impact of political divisions is seen as hindering progress across all aspects of society.
The current administration is characterized as “crazy” and wanting people to die. This has led to thoughts of seeking medical treatments abroad, in places like Canada or Europe, because “idiots are in charge of the US at the moment.” The inclusion of COVID-19 in some of these discussions is seen as a trigger for certain political factions, potentially complicating broader public health efforts.
There’s a bit of self-awareness in one comment that asks how many of those criticizing actually get their flu shot annually, implying a potential disconnect between outrage and personal action. Nevertheless, the FDA is being described as “on a hot streak,” albeit sarcastically, for actions that are seen as detrimental.
The idea that politicians need to profit from these situations is also raised, contributing to the cynical view of the process. Even international observers are weighing in, expressing distrust in “pharma bros” and their practices, though suggesting the U.S. is particularly adept at “dirt money.”
The situation is described in stark terms: “Americans are so fucked.” There are even humorous, albeit dark, comparisons to “Resident Evil” reboots, suggesting a descent into chaos. The principle of separating church and state is invoked, perhaps implying that religious or ideological fervor is interfering with rational governance.
The ultimate implication of this refusal is a stark warning about the future of healthcare and innovation in the United States. If experimental treatments, even those from established companies with a proven track record, are subject to such barriers based on non-scientific grounds, it raises serious questions about the country’s ability to protect and advance public health. The call for transparency from both Moderna and the FDA is strong, emphasizing that vague statements are unhelpful and that the scientific and regulatory processes should be open to scrutiny.