NEW STUDY: COVID-19 Replicon samRNA Injections Induced Severe Blood Abnormalities in 93% of Trial Participants

Despite major safety signals, the FDA, BARDA, Gates Foundation, and Arcturus Therapeutics continue to fast-track this experimental platform for mass deployment.

By Nicolas Hulscher, MPH

A newly published clinical trial has revealed very serious safety concerns surrounding self-amplifying mRNA (replicon) injections—the same technology now being rapidly advanced by the FDA, BARDA, the Gates Foundation, and Arcturus Therapeutics for H5N1 bird flu.

In a Phase 1 trial conducted in Uganda, Kitonsa et al tested a COVID-19 replicon samRNA injection encoding the spike protein in 42 healthy adults. The findings were deeply concerning:

A total of 39 Grade 3 or higher laboratory abnormality adverse events occurred after the second dose—equivalent to 93% of the trial’s participants.

Grade 3 events are defined by regulatory agencies as “severe or medically significant”, often requiring clinical intervention. The most common abnormalities were:

• Thrombocytopenia (low platelet count, internal bleeding risk)

• Lymphopenia (suppressed adaptive immune response)

• Neutropenia (lowered neutrophils, increasing infection risk)

Moreover, 85.4% of participants experienced systemic adverse events such as muscle pain, joint pain, vomiting, and fever. Laboratory abnormalities intensified after the second dose, suggesting cumulative toxicity or immune priming. Concerningly, these adverse events occurred in healthy adults.

Vaccines 2025, 13(6), 553; https://doi.org/10.3390/vaccines13060553

Despite these findings, the authors described the vaccine as “well tolerated”—a characterization that sharply contradicts their own data.

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FDA Fast-Tracked the Same Platform for Bird Flu

While the Kitonsa study involved a COVID-19 samRNA shot, the same replicon RNA technology is now being deployed for H5N1 bird flu injections.

In November 2024, the FDA authorized a Phase 1 trial for ARCT-2304, a self-amplifying H5N1 injection developed by Arcturus Therapeutics. The effort is backed by BARDA and the Gates Foundation.

In April 2025, the FDA granted Fast Track Designation to ARCT-2304:

BREAKING: FDA Fast Tracks Self-Amplifying mRNA Bird Flu Injection

We are very concerned that regulatory shortcuts are being applied to novel replicon injections that have already demonstrated severe systemic toxicity in clinical trials.

However, we may hear some positive news regarding this soon, as HHS has just terminated two major contracts worth $766 million with Moderna for its experimental conventional mRNA H5N1 bird flu injections because the shots were found to not be “scientifically or ethically justifiable.”

We can only hope that similar action is taken on the dangerous replicon mRNA platforms.

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A Global Replicon Rollout

This is not an isolated case. At least 33 self-amplifying mRNA injection candidates are currently in development worldwide. Arcturus Therapeutics’ COVID-19 replicon injection (ARCT-154) has already been approved in:

• India (June 2022)

• Japan (November 2023)

• European Union (February 2025)

European Approval of Experimental COVID-19 Replicon mRNA Injections is a Grave Mistake

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Whether targeting COVID-19 or H5N1, these replicon injections share a common synthetic platform—built to replicate inside the body and prolong exposure to bioactive viral proteins.

When a 42-person trial results in 39 severe laboratory abnormalities after a second dose, that’s not an outlier—it’s a serious warning.

Despite these red flags, the FDA, BARDA, the Gates Foundation, and Arcturus Therapeutics continue to accelerate this technology toward mass distribution. All of these players belong to the Bio-Pharmaceutical Complex:

If we allow this experiment to continue unchecked, the global population will be in serious danger:

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Kitonsa J, Serwanga J, Cheeseman HM, Abaasa A, Lunkuse JF, Ruzagira E, Kato L, Nambaziira F, Oluka GK, Gombe B, et al. Safety and Immunogenicity of a Modified Self-Amplifying Ribonucleic Acid (saRNA) Vaccine Encoding SARS-CoV-2 Spike Glycoprotein in SARS-CoV-2 Seronegative and Seropositive Ugandan Individuals. Vaccines. 2025; 13(6):553. doi: 10.3390/vaccines13060553

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Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

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