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

BARDA- and Gates-funded experimental replicon shots move toward accelerated approval.

By Nicolas Hulscher, MPH

In November 2024, the FDA green-lit a Phase 1 trial for the Arcturus Therapeutics self-amplifying (replicon) H5N1 "pandemic" bird flu injection (ARCT-2304):

These experimental replicon shots are primarily funded by BARDA with support from the Gates Foundation, who gave Arcturus Therapeutics a $928,563 grant in October 2024 to “improve understanding of durability of protection after administration of nucleic-acid based vaccines.”

Yesterday, Arcturus Therapeutics received U.S. FDA Fast Track Designation for the replicon injection ARCT-2304:

According to the FDA:

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

It’s important to understand that these products behave like a synthetic virus. The replicon mRNA is designed to encode not only the target antigen but also viral replicase, enabling the mRNA to replicate itself within the target cells. This replication machinery allows for an unknown period of toxic antigen production and an increased probability of shedding:

In a grave mistake, the European Commission recently approved COVID-19 replicon mRNA injections (ARCT-154) developed by Arcturus Therapeutics:

As I outlined last year, there are currently at least 33 samRNA vaccine candidates in development:

Here is the current timeline of self-amplifying mRNA injection approvals:

• FEB 2025 - EU approves COVID-19 samRNA vaccine (Arcturus Therapeutics - ARCT-154).

• NOV 2024 - U.S. FDA authorizes trial for H5N1 bird flu samRNA vaccine (Arcturus Therapeutics - ARCT - 2304).

• NOV 2023 - Japan fully approves COVID-19 samRNA vaccine (Arcturus Therapeutics - ARCT-154).

• JUNE 2022 - India authorizes very first COVID-19 samRNA vaccine for human use (Gennova Biopharmaceuticals - GEMCOVAC-19).

Last month, I told Dr. Drew and his audience that experimental self-amplifying mRNA shots risk irreversible population harm and should be halted:

It's become abundantly clear that the pharmaceutical industry and captured regulatory agencies have zero regard for the massive safety concerns of undefined synthetic mRNA replication resulting in uncontrolled toxic antigen production. The fact that our FDA issued Fast Track Designation for an experimental replicon mRNA bird flu injection is deeply worrisome. It would take decades to understand the full safety profile of these self-amplifying genetic products.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

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