HHS BARDA Awards Cidara $339M for Injectable Influenza Drug CD388 Amid International Bird Flu Pandemic Orchestration
CD388 uses plasmids in its manufacturing process, raising human genome integration concerns.
The Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) has awarded Cidara and its influenza drug CD388 $339 million, the biotech company said Thursday.
Many countries are simultaneously performing dangerous gain-of-function-style experiments on avian influenza “bird flu” pathogens while developing vaccines and other drugs to treat the very virus they’re making more destructive (see list of articles at the bottom of this publication).
The new BARDA deal includes $58 million over two years, which will be used to “stand up domestic manufacturing for CD388 in the U.S.” and help Cidara establish its “initial commercial supply chain,” according to a press release.
The FDA awarded CD388 Fast Track designation in June 2023.
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Cidara said the massive new funding will support trials and studies aimed at preparing CD388 for pandemic-grade influenza strains and broader population use.
“That initial tranche of cash will also fuel a clinical trial comparing a higher-concentration formulation and different presentations of CD388, help the company further characterize the asset’s activity against pandemic flu strains in nonclinical models and kick off development of trial protocols for expanded populations, Cidara said.”
The remaining $281 million could be used for studies of CD388 “in specific populations.”
Jeffrey Stein, Ph.D., Cidara’s chief executive, said the U.S. taxpayer dollars will “both expand our commercial supply capacity, as well as ensure U.S. supply of CD388 in the event of an influenza pandemic.”
Though injectable, CD388 is not a vaccine and does not work by stimulating the immune system to produce an immune response.
Instead, CD388 is a long-acting antiviral drug-Fc conjugate that is said to directly inhibit the influenza virus’s ability to replicate.
It is said to provide protection by acting as a small molecule inhibitor rather than training the immune system to recognize the virus.
The company explains:
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status
Safety Concerns Surrounding Cidara’s CD388 Drug
Cidara Therapeutics’ experimental influenza prophylactic, CD388, is raising red flags that go largely unmentioned in the company’s public statements.
While marketed as a breakthrough “non-vaccine” pandemic countermeasure, its own clinical trial records and manufacturing disclosures reveal several troubling details.
Participants in Cidara’s Phase 2b study were instructed to avoid pregnancy, sperm donation, and even blood donation for roughly seven months following a single subcutaneous injection—a restriction far longer than standard antivirals and suggestive of extended systemic persistence or possible reproductive-toxicity risk.
The protocol also monitors subjects for nearly 200 days post-dose, tracking cardiac, hematologic, and metabolic outcomes—a sign of concern for delayed or cumulative adverse effects rather than short-term reactogenicity.
Exclusion criteria bar individuals with heart-rhythm abnormalities (QT prolongation), hinting at potential cardiac liability.
The study further restricts anyone who recently received an influenza vaccination, implying possible drug–vaccine interaction or interference.
Despite these safety caveats, Cidara’s registry entry states it will not share individual participant data, blocking independent verification of adverse-event patterns.
Compounding these issues, CD388’s manufacturing process itself introduces another layer of concern.
According to a 2025 Nature paper detailing the drug’s construction, plasmids are used to produce the biologic component of CD388.
The study states:
“The constructed plasmid was transfected into suspension ExpiCHO cells (Gibco) per manufacturer protocol and collected after 13 days. The Fc ... has two modifications... The Fc domain was purified and then conjugated chemically to multiple zanamivir dimers.”
In practical terms, this means recombinant DNA plasmids drive the production of the engineered human IgG1 Fc fragment, which is later chemically linked to a synthetic antiviral drug (zanamivir dimers).
The plasmid stage—though standard in biologic antibody production—still involves recombinant DNA vectors capable of containing and expressing modified human genetic material, raising the same genome-integration and contamination risks previously documented in other plasmid-based biopharmaceuticals.
If plasmids carrying the C220S and YTE mutations were to integrate into the human genome after injection, potential risks could include:
Disruption of normal genes: Integration might interrupt important genes, causing them to malfunction or not produce necessary proteins.
Activation of oncogenes: Insertion near cancer-related genes could potentially trigger uncontrolled cell growth and lead to cancer.
Altered immune responses: The engineered Fc domain with these mutations might affect natural immune regulation if expressed uncontrollably.
Long-term unpredictable effects: Since these mutated sequences are not naturally part of the genome, their integration could cause unknown changes in gene expression or cell behavior.
Overall, unintended genomic integration carries risks of gene disruption, cancer, immune dysregulation, or other unforeseen biological consequences, so integration of such plasmid DNA into human chromosomes is considered potentially harmful and carefully avoided in therapies.
Taken together, CD388 represents a long-acting, plasmid-engineered biologic hybrid with uncertain reproductive, cardiac, and genomic safety, produced through recombinant DNA transfection and PEG-linked chemical conjugation—yet publicly branded as a simple “non-vaccine.”
With BARDA now investing up to $339 million to mass-produce it as a pandemic countermeasure tested against H5N1 and H7N9 avian flu under BSL-3 conditions, the absence of disclosed immunogenicity data and the drug’s extended persistence in the body make transparent, independent safety evaluation more urgent than ever.
These developments point to a coordinated international framework in which governments and pharmaceutical partners are simultaneously engineering, weaponizing, and medicating against the same avian influenza viruses—a cycle that risks turning so-called “pandemic preparedness” into a self-perpetuating system of global bio-orchestration.
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Better give those to priority government officials, public reps and the Generals first.
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