FDA Rejects Moderna's Flu Shot Application A Very Bad Mishap

• FDA declines to review Moderna's application for its mRNA-1010 flu shot citing issues with clinical trial design.
• Moderna disputes the FDA's reasoning, asserting that trial design was previously discussed and agreed upon.
• The rejection follows changes in U.S. immunization policy and the appointment of a new vaccine regulator at the FDA.
• Moderna expects potential delays in approval for its flu shot in the U.S., impacting its 2026 financial outlook.

A Sad Day For Moderna, a Sad Day For Kazakhstan

Jagshemash, my name is Borat Sagdiyev, and I am reporting to you live from… well, not Kazakhstan this time. I am in Americastan, where very strange things are happening with the medicines. Moderna, a big company like my neighbor Nursultan Tulyakbay who has four goats, is having troubles with their new flu shot. FDA, the big cheese of medicines here, says 'nyet' to reviewing it. Is like saying 'nyet' to good time at the running of the Jew. Very bad.

The Trump Man Strikes Back From The Grave

The problem, it seems, is that the FDA does not like how Moderna made the test for the flu shot. They say it is not 'adequate and well-controlled.' Moderna say they agreed to this before, but now, things are different. Is like when I agree to marry Pamela Anderson, but then she see my wife and say 'nyet'. Very confusing. And this Robert F. Kennedy Jr., he is making big changes to how they do the vaccine in U.S. I don't know about it, but it reminds of situation of Japan's Stock Market Hits Record High Following Election Triumph, where I have been told that everyone is getting richer and more wealthy but the situation is exactly opposite and the Trump man is to be blamed.

Vinay Prasad, The New Sheriff In Town

This Vinay Prasad, the head of vaccines at FDA, is like new sheriff in town. He wants to make rules harder. He say the Moderna way is not good enough. Moderna say, 'But we talked about this' He reply like 'Chenqui!' is a new Kazakhi word meaning, you show me good proof and I approve.

Moderna Fights Back With Science

Moderna's leader, Stéphane Bancel, is not happy. He says FDA is not helping America be number one in medicine. He wants them to look at the flu shot fairly. He say it is not controversial to compare to other approved flu shot. Very reasonable, like asking for only one kiss from prostitute, but I am not getting any.

Great Success...Maybe Not

So, what does this mean? It means Moderna might have to wait until 2026 or 2027 to get this flu shot approved. They are waiting for Europe, Canada, and Australia also. This is like waiting for my neighbor to pay me back for helping him milk goat, a long time.

Is This a Conspiracy?

I do not know if this is a conspiracy, but I think it is not fair to Moderna. They are trying to make good medicine. Maybe FDA is being too strict, like my mother-in-law with my wife. We will see what happens, but for now, it is not great success. Chenqui!