A SHOT IN THE DARK

Unpacking the FDA’s Rush to Approve a Replicating Vaccine—Is This Innovation or a Global Risk?

A Shot in the Dark

Why is the FDA rushing a Bird Flu vaccine that replicates like a virus? Imagine a vaccine that doesn’t just sit in your body—it replicates like a synthetic virus, spreading its code inside your cells. That’s ARCT-2304, a self-amplifying mRNA shot for H5N1 bird flu, developed by The Gates Foundation sponsored Arcturus Therapeutics in San Diego, where Phase 1 trials kicked off in November 2024. Why the rush? President Trump’s FDA granted it Fast Track designation in April 2025, signaling urgency for a disease that’s not currently a pandemic threat. How did this happen so fast? With the Gates Foundation and BARDA bankrolling it, questions swirl: Is this about saving lives—or something darker? This matters to you because an untested vaccine with the power to “shed” could change everything. Let’s dig into the truth behind this alarming experiment.

YOUTUBE, TimCast, 14 April, 2025. "Trump Admin FAST TACKS New mRNA Vaccine For Bird Flu, Harvard Warns A PANDEMIC May Be Coming," https://www.youtube.com/watch?v=j0HPGI0lEm8 ^[2]

Unpacking the H5N1 Vaccine Push

ARCT-2304 isn’t your typical vaccine. Unlike traditional mRNA shots, it’s self-amplifying—meaning it replicates its genetic instructions inside your cells to produce H5N1 antigens, potentially at lower doses but with unknown risks like shedding^[1]. Arcturus Therapeutics, backed by the Gates Foundation’s $782,543 grant in October 2024, started Phase 1 trials in November 2024, enrolling 200 healthy adults across U.S. sites^[2]. The FDA’s Fast Track designation in April 2025 aims to speed up development, but H5N1 isn’t a current public health crisis—human cases are rare, with a 50% mortality rate but low transmission^[3].

CBS NEWS, 60 Minutes, Bill Whitaker, Heather Abbott, 20 April, 2025, “Bird Flu,” https://www.cbs.com/shows/video/MtuLxdB5T2kMvR5GCNbw776hQZsybrBe/^[14]

So what’s true? The vaccine’s tech is innovative, promising stronger immunity. What’s not? Claims of a “bioweapon” lack evidence; H5N1’s threat is real but overstated. Who’s spinning? The Trump administration, accelerating this via BARDA’s funding (contract 75A50122C0007), may be pushing pandemic preparedness to justify budgets. Critics like Nicolas Hulscher on X warn of “irreversible population harm”^[4]. Meanwhile, Gates’ $10B global vaccine advocacy raises questions about influence over public health^[5].

UNITED STATES SENATE, Oversight Committee, 2024 - 06-18 - Senate Homeland Security Hearing - examining 'available evidence' on the origins of COVID-19, H5N1 & Gain of Function Research. Witness Ebright, R., Ph.D., https://www.youtube.com/watch?v=Gt9BNBSMW3U

The Data Behind ARCT-2304

Let’s break down the facts. ARCT-2304, developed by Arcturus Therapeutics, uses self-amplifying mRNA (sa-mRNA) technology, which allows the vaccine to replicate its genetic material inside your cells. According to Arcturus’ vice president Neda Safarzadeh, “LUNAR-H5N1’s self-amplifying mRNA platform enhances immune response and offers better liver durability, providing a more robust and lasting defense compared to conventional vaccines”^[6]. This sounds promising—Phase 1 trials, launched in November 2024, are testing 200 adults aged 18–80 across multiple U.S. sites, measuring immune responses via hemagglutination inhibition and virus neutralization assays^[2]. Interim data, expected in late 2025, will reveal if smaller doses can indeed trigger stronger immunity, a potential game-changer for pandemic preparedness.

GOODDOG MEDIA, LLC, QBits, 22 April, 2025, GoodDog, “Counter-Revolution,” A Shot In The Dark Segment, https://www.gooddog-usa.com/army-of-light

But here’s the catch: self-amplifying mRNA is experimental. Unlike the COVID-19 mRNA vaccines from Pfizer and Moderna, which degrade quickly, sa-mRNA replicates in the body, raising concerns about uncontrolled antigen production or shedding—where the vaccine’s components might spread to others^[1]. Nicolas Hulscher, an MPH on X, warns, “ARCT-2304 replicates inside your cells like a synthetic virus—producing toxic antigens and potentially shedding for an unknown duration” [4]. And, as observed by Brian Hooker, Ph.D., Chief Scientist at Children’s Health Defense Fund,

CHILDREN'S HEALTH DEFENSE FUND, Hooker, B., PhD, Chief Science Officer, 'mRNA Vaccines are designed to shed, they are designed to basically vaccinate innocent bystanders,' 23 January 2025, https://x.com/ChildrensHD/status/1882430631340114071

“ Those are designed to shed, those are designed to basically vaccinate innocent bystanders. Are we dealing with the same shedding situation that we dealt with with the Covid shots, the mRNA vaccines? Yeah, same thing. Covid shot. And so you would expect shedding of these vaccines. And now with the advent of self-replicating Messenger, RNA.

Uh, which is the vaccine that, uh, has been approved in Japan, then you know that they're going to roll out this technology and those are designed to shed, those are designed to basically vaccinate innocent bystanders. We do not wanna be near you if you've had that shot. Okay? So just heads up, if you're gonna take, be dumb enough in this day and age to take a bird flu shot, sorry.

But that's the way it is. How can you possibly think with all the science that you've just told us that that is a good idea? Right? Then please stay away from us.”

Brian Hooker, Ph.D., Chief Scientific Officer, CHD, 23 January, 2025

ARCTURUS THERAPEUTICS, FDA Fast Track Certification Award, 10 April, 2025, https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-receives-us-fda-fast-track-designation-0^[15]

Funding fuels the fire. The Gates Foundation donated $782,543 in October 2024 to Arcturus to study nucleic-acid vaccine durability, directly supporting ARCT-2304^[2]. Gates’ broader vaccine efforts are staggering: $4.1 billion to Gavi and $10 billion for global vaccine initiatives since 2010^[5]. BARDA, under contract 75A50122C0007, fully funds the project, leveraging its pandemic preparedness mandate^[1]. No other private donors are confirmed, but the Trump administration’s acceleration of this Gates-funded vaccine has sparked debate. A Natural News article claims, “The Trump administration has once again thrown its weight behind controversial vaccine technologies,” tying this to Operation Warp Speed’s legacy^[8].

What about the “criminal conspiracy” angle—a eugenicist pushing an untested bioweapon for a non-deadly illness? H5N1 is deadly (50% mortality in human cases), but transmission is low, with only 868 cases reported globally from 2003 to 2023^[3]. The CDC confirms no current vaccine exists for H5N1, though candidate viruses are ready if needed^[2]. The bioweapon claim lacks evidence—no primary sources link Gates or Arcturus to eugenics. However, the FDA’s history of corruption, as Dr. Wojak, M.D. notes on X, raises red flags: “The FDA isn’t flawed. It’s criminal,” citing 33% of approved drugs from 2001–2010 later withdrawn for safety issues^[9]. Video from a 2025 FDA oversight hearing echoes this: “We’ve seen reckless approvals,” a whistleblower testifies at 5:20^[10].

THE MCCULLOUGH FOUNDATION, Hulscher N., Epidemiologist, “Experimental self-amplifying replicon mRNA injections risk permanent population harm,” 11 April, 2025, https://x.com/McCulloughFund/status/1910742304002105560

Why This Matters

This isn’t just about a vaccine—it’s about trust in the systems that control your health. If ARCT-2304’s self-amplifying tech goes wrong, the stakes are catastrophic. Uncontrolled replication could lead to immune overreactions or shedding, affecting not just you but your community^[1]. Financially, the ripple effects are massive—healthcare costs from vaccine injuries could dwarf the $1.4 trillion U.S. economic activity tied to pandemics^[11]. The Gates Foundation’s influence, with $10 billion in vaccine initiatives, suggests a future where unelected billionaires shape public health^[5]. What’s next? If the FDA fast-tracks more untested tech, we’re on a slippery slope to medical tyranny. The invasive motive of profit must be removed from the value chain of medical delivery, or, medicine will continue to attract those willing to sacrifice quality of care in exchange for riches.

RUMBLE, Bannon, S., War Room with Special Guest Naomi Wolf, CEO Dailyclout.io, 22 April, 2025, https://rumble.com/embed/v6q941h/?pub=4

The human angle hits hard. Imagine a parent, trusting the FDA, vaccinating their child—only to face lifelong health issues from an experimental shot. Dr. Wojak, M.D., warns on X, “Healthcare is the #1 cause of death,” citing 400,000 annual U.S. deaths from medical errors and adverse drug reactions^[12]. This isn’t sci-fi; it’s a real risk unfolding now. With interim data due in late 2025, the clock is ticking. Will this vaccine save lives—or become a Pandora’s box?

Bibliography

1. Contagion Live. (10 April, 2025). FDA Grants Fast Track Status to ARCT-2304. https://www.contagionlive.com/view/fda-grants-fast-track-status-to-arct-2304-for-h5n1-influenza-protection

2. [Video] YOUTUBE, TimCast, 14 April, 2025. "Trump Admin FAST TACKS New mRNA Vaccine For Bird Flu, Harvard Warns A PANDEMIC May Be Coming," https://www.youtube.com/watch?v=j0HPGI0lEm8

3. CDC. (2023). Avian Influenza A (H5N1): H5 Bird Flu: Current Simulation, 22 April 2025, Data. https://www.cdc.gov/bird-flu/situation-summary/index.html

4. Hulscher, N. [@NicHulscher]. (2025, April 11). FDA Fast Tracks Gates-Funded ARCT-2304. https://x.com/NicHulscher/status/1910737331679568315

5. Economic Times. (2025). Bill Gates’ Vaccine Advocacy. https://economictimes.indiatimes.com/panache/panache-people-101/bill-gates/profileshow/79020550.cms

6. [Video] Safarzadeh, N., 26 May, 2024, Interview on LUNAR-H5N1, “Arcturus’ Vice President Neda Safarzadeh, H5N1” Arcturus Therapeutics, https://www.youtube.com/watch?v=WfRUUeNBTaQ

7. [Video] Dr. Freiberg, Jeff, Emerging Threats and Key Knowledge From 2024 Trending Into 2025, 25 February, 2025). [6:25]. Contagion Live YouTube Channel. https://www.youtube.com/watch?v=Vt0y6T-3sR0

8. Natural News. (2025). Trump Accelerates Gates-Funded Bird Flu Vaccines. https://www.naturalnews.com/2025-04-15-trump-accelerates-gates-funded-self-amplifying-bird-flu-vaccines.html

9. Dr. Wojak, M.D. [@DrWojakMD]. (2025, April 8). FDA Corruption Thread. https://x.com/DrWojakMD/status/1909568545052410047

10. [Video] UNITED STATES HOUSE OF REPRESENTATIVES, House Oversight Hearing, “Hearing on preparation for next pandemic,” 14 November, 2024. [02:18:45]. PBS News YouTube Channel. https://www.youtube.com/watch?v=88dXGAqk6q8

11. Mckibbin, W., Fernando, R., ResearchGate Journal, 01 October, 2023, Global Economic Impact of Pandemics. https://www.researchgate.net/publication/374731857_The_Global_Economic_Impacts_of_the_COVID-19_Pandemic

12. Dr. Wojak, M.D. [@DrWojakMD]. (2025, March 18). Healthcare Death Toll Thread. https://x.com/DrWojakMD/status/1901964587739623861

13. Reuters, 26 February 2025, “Trump administration weighs pulling funding for Moderna bird flu vaccine, Bloomberg News reports,” https://www.reuters.com/business/healthcare-pharmaceuticals/trump-administration-weighs-pulling-funding-moderna-bird-flu-vaccine-bloomberg-2025-02-27/

14. [Video] CBS NEWS, 60 Minutes, Bill Whitaker, Heather Abbott, 20 April, 2025, “Bird Flu,” https://www.cbs.com/shows/video/MtuLxdB5T2kMvR5GCNbw776hQZsybrBe/

15. ARCTURUS THERAPEUTICS, FDA Fast Track Certification Award, 10 April, 2025, https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-receives-us-fda-fast-track-designation-0

16. GOODDOG MEDIA, LLC, QBits, 22 April, 2025, GoodDog, “Counter-Revolution,” https://www.gooddog-usa.com/army-of-light

17. CHILDREN'S HEALTH DEFENSE FUND, Hooker, B., PhD, Chief Science Officer, 'mRNA Vaccines are designed to shed, they are designed to basically vaccinate innocent bystanders,' 23 January 2025, https://x.com/ChildrensHD/status/1882430631340114071

18. THE MCCULLOUGH FOUNDATION, Hulscher N., Epidemiologist, “Experimental self-amplifying replicon mRNA injections risk permanent population harm,” 11 April, 2025, https://x.com/McCulloughFund/status/1910742304002105560

19. UNITED STATES SENATE, Oversight Committee, 2024 - 06-18 - Senate Homeland Security Hearing - examining 'available evidence' on the origins of COVID-19, H5N1 & Gain of Function Research. Witness Ebright, R., Ph.D., https://www.youtube.com/watch?v=Gt9BNBSMW3U