Awkward moment: The FDA refuses to file Moderna's mRNA flu shot biologics license application.

How long is this standoff going to last? I am not holding my breath for now...

Dear Readers,

As a front matter, I am beyond grateful for everyone who provided donations, support and prayers for the upcoming court/press event in Amsterdam:

Breaking: I am going to the court in Amsterdam on March 9. Press conference same day.

Thank you for my all paid subscribers. You make this work possible!

Special thanks to:

Ellen R
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Your support matters more than you can imagine. This case is being prosecuted on a shoestring budget, with 1 attorney, while we are being totally stonewalled by media.

I am also very grateful to those who are supporting attorney Warner Mendenhall and praying for his health.

As to the main topic of this post. What just happened at the FDA?

On February 3, the FDA took one of the harshest steps it can take on an application. In an unusual disclosure of what are typically confidential communications between companies and the regulator, Moderna published the refuse-to-file letter that was signed by vaccines and biologics chief Vinay Prasad. I am not sure why the mRNA name is redacted. Moderna’s public information names the flu shot as mRNA-1010:

the next paragraph contains a typo:

Perhaps I am too nitpicky here. Certainly, my own posts often contain typos! However, I do not have a multi-billion dollar budget, nor do I have 10,000+ staff to make sure important letters like this don’t go out looking so home-made. What this lack of quality control may mean: the letter did not go through the usual quality checking.

That aside, the only legal basis for not filing Moderna’s BLA application cited by Prasad is the Public Health Services Act statute for “lack of adequate and well controlled” trial design. The other law cited (FDCA) only applies to the fee Moderna paid upfront for the FDA review. Prasad says they will get 75% of this fee refunded.

Does Prasad have any leg(s) to stand on in this standoff?

As justification for his decision, Prasad says Moderna did not use the “best-available standard of care” in the control arm of the study.

The Phase 3 trial tested Moderna’s mRNA-based flu shot in ~40,000 adults 50 years and older. I find it fascinating and absolutely amazing that these companies consistently find 40,000 volunteers for the deadly juice they brew. Even though the targeted population gets progressively smaller because they are now progressively sicker and more dead. How do they complete these magic enrollment targets? Do they dig up the graves? Do they use the Dominion voting machines?

Alright. Let’s assume they did actually find that many to inject. As to the other design aspects, Moderna did not use placebo as control (duh! that would make poison show up as poison) but used a standard flu vax dose as a comparator vaccine. Does this make Prasad’s case? No! There is no law or FDA policy that prescribes what Phase 3 trial design should entail for new flu vaccines. However, known regulatory expectations state that “comparator arms can be licensed vaccines rather than placebo if an effective vaccine already exists”. The manufacturer and FDA must agree on the best-available standard of care comparator in the population studied.

Because clinical trials take a long time and cost a lot of money, the FDA commits to a particular Phase 3 trial design as a negotiated matter with the manufacturer, typically years ahead of review and approval. In Moderna’s mRNA-1010 case, apparently, that commitment took place in 2024. This design does not contradict any of the current FDA policies or the applicable US law. In a statement announcing the news on Tuesday, Moderna said that not only did its comparator have a history of being used in pivotal flu trials, but the FDA had never suggested the application wouldn’t be reviewed over multiple interactions spanning more than a year. It also said there was no precedent for the agency requiring a comparator to be the best option available.

What is interesting, the media is pushing the narrative that Moderna did not jab the participants in the control arm with the highest possible dose of a standard flu shot! They didn’t “standardly care” well enough, you see! However, this specific argument is nowhere to be found in Prasad’s refusal-to-file letter.

Prasad states that the FDA communicated to Moderna previously that their trial design is inadequate, however Moderna disputes this. They also say they have written communications from the FDA as receipts, and I actually trust that they do.

Moderna is now awaiting a response from the FDA on its request for a type A meeting to get more details on the FDA’s decision, which should happen within 30 days. The biotech had used significant outside financing to fund the trial: The private equity investor Blackstone Life Sciences said in 2024 that it would provide as much as $750 million for the flu program. I also find it interesting that despite having made a mountain of money from their covid shots, Moderna, a public company, has a private equity fund behind a specific product, the flu shot. Why does it take this much cash? Who are the private investors behind this vehicle, how many of them are Epstein’s clients, and what are their preferred rights vs. common shareholders of Moderna stock?

For the sake of completeness, the information not mentioned in relation to this controversy is the “super strong superior efficacy” that mRNA-1010 demonstrated - a whopping 26% relative efficacy!! For reference, recall that mRNA covid shots claimed 95% relative efficacy in Phase 3 trials. That translated to ~1% absolute efficacy. Given that the risks of flu and covid are identical, the absolute efficacy for mRNA-1010 must be around very negative numbers. Also, recall, that even the lamest of the lame WHO guidelines for vaccines require ~30%-50% efficacy range as an acceptable target. The FDA, when it suits them, sides with these guidelines, and doesn’t really publish their own.

I tried to find any published safety data for mRNA-1010, and of course nothing to be found! Trust the science.

How long will this miraculous standoff last? Well, let’s consult history. The previous standoff of Prasad v Sarepta (the toxic gene therapy shot “approved” by Peter Marks), ended quickly and resulted in nothing. The product remains on the market despite zero efficacy and despite killing people.

Next question - who thinks that Prasad is really this stupid? I, for one, don’t think that, despite my generally low opinion of the bunch of clowns in charge of the FDA right now. Here are the available options:

-Prasad is awesomely dumber than anyone thought; or

-Prasad is playing games that he knows are guaranteed to fail.

Why do I believe it is the latter? Lots of reasons: a stunt like this would temporarily combat the dissenting MAHA critics (like myself) and advertise some decisive bold moves against Big Pharma - moves which are guaranteed to generate lots of noise in the media but are also guaranteed to fail in practice. The wailing from the mainstream about the “assault of those awful anti-vaxxers like Prasad on the sacredness of the sacred elixirs of health and safety, the vaccines!!!” is likely to generate another wave of FOMO desire amongst the boomers to suicide themselves at a local pharmacy with yet another booster. However, my money is on this stunt being a PR strategy.

At the same time, if this really stops Moderna’s mRNA flu shot approval, the FDA effectively removes a whole class of competitors for the NIH-owned “whole flu virus” platform, patented by Fauci’s replacement, Jeffrey Taubenberger, into which MAHA administration pumped $500M. Let’s also not forget that BARDA and MAHA-HHS allocated another ~$400M cash to a “non-vaccine biologic” to prevent flu in the next pandemic! Is this standoff really about MAHA-HHS vs Blackstone on whose pony is going to run in the “next pandemic”?

They are throwing another bone to the critics of the MAHA administration who are vocal about zero real action on mRNA vaccines. In 2025, approximately 6 million children received an mRNA covid “booster”. In addition 450,000 servicemembers were jabbed with this heart attack, stroke and cancer-causing “military readiness” cocktail! While Jay Battacharya, the beloved gentle MAHA nerd and Fauci-Collins understudy, assured us, in the interview with Jan Jekielek of The Epoch Times that he has no idea what causes autism, but he is absolutely certain it’s not the vaccines! In other words, “eat real shit cake food! (TM) Signed, Marie Antoinette.

As I mentioned above, I am not holding my breath.

Art for today: Foxgloves, watercolor, 11x14 in.