The Self-Amplifying Technology of the Kostaive Serum Remains Unexplored, Yet Risks to Healthy Individuals Have Been Overlooked.
Before the drug is commercialized, institutions must initiate investigations conducted by researchers without conflicts of interest.
The European Medicines Agency (EMA) has approved Kostaive, a new anti-Covid-19 vaccine based on self-amplifying RNA (saRNA). This technology uses RNA molecules capable of replicating themselves within cells, promising lower doses and a prolonged immune response thanks to the RNA’s persistence and higher concentrations of the Spike protein.
saRNA Technology: Potential Biological Risks to Be Assessed
The saRNA technology, derived from engineered alphaviruses, results in massive duplication of viral RNA within cells and high expression of the Spike protein. The use of this technology—more recent than traditional mRNA—raises safety concerns for healthy individuals that require in-depth investigation.
Potential Systemic Spread and Infectious Extracellular Vesicles
It is crucial to study the potential distribution of saRNA molecules throughout the body. Research on alphaviruses similar to saRNA indicates that the intracellular accumulation of viral RNA can lead to the production and release of extracellular vesicles containing viral genetic material. These vesicles may propagate within the body and amplify Spike protein expression.
Vesicle-Mediated Transmission: An Urgent Topic for Investigation
The transmission of viral genetic material via extracellular vesicles is a well-documented phenomenon for several viruses. It is essential to investigate whether this mechanism is relevant to Kostaive’s saRNA, particularly considering its ability to induce sustained biological expression of the Spike protein—raising potential concerns regarding adverse effects and immune responses.
Airborne Spread Risk: Further Scientific Questions
Extracellular vesicles containing saRNA may reach lung tissue and be released through exhalation, with potential environmental implications. Moreover, the ability of these vesicles to potentially enter various cell types without protective barriers presents a scientific concern that warrants further study.
The Need for Independent Research on Safety
It is of utmost importance to conduct thorough preliminary research into the potential safety risks associated with Kostaive’s saRNA technology prior to widespread use. Independent scientific studies are necessary to assess biological risks and ensure public safety.
Source: “La Verità”
Authors
- Mariano Bizzarri (Sapienza University of Rome)
- Marco Cosentino (University of Insubria)
- Alberto Donzelli (Former Member of the National Health Council)
- Maurizio Federico (Italian National Institute of Health)
- Giovanni Frajese (Foro Italico University)