Moderna's Flu Shot Stalled FDA Rejection Raises Eyebrows

• FDA rejects Moderna's flu shot application due to concerns over trial design, not safety or efficacy.
• Moderna disputes FDA's reasoning, claiming the agency previously approved the study design.
• The decision could delay the potential approval of Moderna's flu shot until late 2026 or 2027.
• Moderna has requested a meeting with the FDA to discuss the path forward amidst changing US immunization policy.

A Licence to...Wait A While

Well, this is a turn-up for the books. It seems Moderna, bless their cotton socks, have hit a snag with their experimental flu shot. The FDA, not exactly known for their lightning-fast decisions, has decided not to review their application. It appears even I, with my "licence to kill," couldn't expedite this process. It's like trying to outrun a SPECTRE agent in a Trabant – frustrating and, ultimately, futile. The share price took a hit, naturally – about 7% after hours. Makes you wonder if someone's been playing poker with company secrets again.

Shaken, Not Stirred...By the Data

Moderna seemed rather miffed, pointing out that this decision is somewhat inconsistent with previous feedback. One might say the FDA has changed its tune faster than I change aliases. Apparently, they aren't thrilled with the study design, despite having given it the nod earlier. As Q would say, "A puzzling development, 007." But I've faced far more perplexing puzzles than this. Remember the time I had to disarm a nuclear weapon with nothing but a paperclip and a dodgy sense of humour? This is almost as complicated. Perhaps this is related to Trump's Truth Social Snafu Apes, Memes and Election Nightmares, though who knows what goes on in those circles.

The Man with the Golden Regulator

Adding a dash of intrigue to this whole affair is one Vinay Prasad, the FDA's top vaccine regulator. Back in August, he made his return to the agency after being briefly ousted. Now, Mr. Prasad has been quite vocal about tightening vaccine regulations. Some say he's been linking child deaths to Covid shots, a rather bold claim, even for a man in his position. This is precisely why oversight is paramount. One rogue agent can undermine the entire operation.

For Your Trials Only

The FDA's primary gripe, as outlined in a letter signed by Mr. Prasad, is the clinical trial design. Apparently, comparing the new shot to a standard flu shot just doesn't cut the mustard anymore. They argue it "does not reflect the best-available standard of care." Well, I've always believed in striving for the best, but sometimes, old standards are reliable for a reason. It's like choosing between a Walther PPK and some new-fangled laser pistol – sometimes, the classic is the way to go.

Never Say Never...To Regulatory Hurdles

Moderna, naturally, disagrees, pointing out that FDA rules don't actually mandate using the absolute top-of-the-line vaccine as a comparator. Their CEO, Stéphane Bancel, even suggested it shouldn't be controversial to conduct a comprehensive review when using an FDA-approved vaccine as a benchmark. He has a point, doesn't he? You wouldn't expect me to fight Oddjob with a feather duster, would you? Though, knowing my luck, I probably could make it work.

The World Is Not Enough...Time, That Is

The upshot of all this? Moderna now expects the earliest possible approval for their flu shot to be in late 2026 or 2027, pending regulatory reviews. Looks like it's back to the drawing board, or perhaps another round of negotiations with the FDA. In the meantime, I'll stick to my usual preventative measures: a well-tailored suit, a dry martini (shaken, not stirred), and a healthy dose of scepticism. After all, the world of espionage – and pharmaceuticals – is full of surprises.