EU Authorizes New Self-Amplifying mRNA Vaccine Amid Safety and Ethical Concerns

Brussels — A letter has been written and sent to the European Commission in which grave concerns are raised regarding the recent authorisation of KOSTAIVE  (ARCT-154), a self-amplifying mRNA (sa-mRNA) “vaccine” approved for use across the European Union. Written by a European physician, the letter highlights a wide array of scientific, regulatory, and ethical issues surrounding the technology, calling into question the safety of the product and the speed with which it was approved.

According to the product sheet, KOSTAIVE  contains ZAPOMERAN. This self-amplifying mRNA molecule instructs the body to produce the spike protein from the original strain of SARS-CoV-2 and an enzyme called replicase, which enables the mRNA to self-replicate within the body. The document claims this production is temporary, but the letter expresses scepticism, drawing comparisons with previous mRNA vaccines, particularly Pfizer’s Comirnaty, where spike protein expression was reportedly detected in recipients up to 700 days after injection.

Concerns Over Duration and Distribution

A concerned European Doctor wrote a critical letter in which the duration of replicase activity was questioned, and whether the self-amplifying genetic material could persist and continue to replicate indefinitely. The letter also raises concerns about the biodistribution of the lipid nanoparticles (LNPs) used to deliver the mRNA. It cites past studies in which such particles reportedly accumulated in significant organs, including the brain, heart, liver, and reproductive system.

Particularly alarming are claims referenced in the letter about “micro tags” allegedly found in newborns from vaccinated mothers—a claim tied to non-peer-reviewed sources and widely disputed in scientific circles but presented in the context of highlighting perceived regulatory oversight failures.

Genetic Modification and Legal Implications

A central argument in the letter is that KOSTAIVE  constitutes a genetically modified organism (GMO) because it uses a replication-proficient alphavirus genomic backbone as a delivery platform—known in the field as a replicon. According to the letter, this characteristic should subject the vaccine to GMO regulatory frameworks such as those governed by the European Food Safety Authority (EFSA). The concern is that the modified genetic material could be transmitted between individuals or species, raising the possibility of recombination events and the emergence of hybrid viruses.

In a related development, Slovak MP and physician Dr Peter Kotlar recently stated that analyses of Pfizer and Moderna vaccine batches used in Slovakia revealed high levels of DNA alongside mRNA. He claimed this DNA could integrate into the human genome, arguing that recipients of such vaccines should be regarded as genetically modified organisms. These statements remain highly controversial and have yet to be independently confirmed by the broader scientific community.

Human Augmentation and Ethical Boundaries

The letter further ties the KOSTAIVE  rollout to broader concerns about human augmentation, referencing a 2021 report published by the UK Ministry of Defence titled Human Augmentation: The Dawn of a New Paradigm. The document refers to vaccination as a form of augmentation and controversially argues that ethical frameworks should not delay the deployment of such technologies when national interests are at stake.

The physician who authored the letter contends that such views undermine informed consent and violate the principle of bodily autonomy. “People are not cattle to be augmented without their obtained consent,” the letter states, framing the EU’s rapid authorisation of KOSTAIVE  as part of a broader ideological and political shift.

EMA Position and Public Debate

The European Medicines Agency (EMA) has approved KOSTAIVE  because its benefits outweigh potential risks, stating that common side effects include injection site pain, fatigue, headache, and mild fever. However, the letter points out that these were also the initial reported side effects of earlier mRNA vaccines, which later saw reports of serious adverse events, including myocarditis, thrombotic events, autoimmune complications and deaths.

In conclusion, the letter urges EU regulators to halt deployment until further independent studies assess long-term safety, environmental impact, and the potential for irreversible genetic alteration. It calls for recognising sa-mRNA technologies as GMOs and demands greater transparency regarding their development and approval.

As this debate unfolds, the rollout of KOSTAIVE  may become a litmus test for how far gene-based technologies can advance under current regulatory frameworks—and how prepared European institutions are to address the ethical challenges they bring.

Specific development of Alpha virus based Replicon “vaccines” against Covid-19 dates back to at least 2020:                      

Overview of Alpha viruses: https://www.sciencedirect.com/topics/medicine-and-dentistry/alphavirus-infecti on 

Why the fixation on using Alpha viruses in a Replicon type “vaccine”? 

The Vietnamese human clinical trial with sa mRNA “vaccines” failed to address the impact on the entire ecosystem and environment: https://www.nature.com/articles/541467-024-47905-1

Inter species Viral Transmission: https://www.sciencedirect.com/journal/current-opinion-in-virology/vol/28/suppl /C 

Whose property are now these GMO’s?  Do GENE EDITING “vaccines” NULLIFY HUMAN RIGHTS?                     https://www.trunews.com/stream/todd-callender-genetic-altering-vaccines-coul d-nullify-human-rights 

REFERENCE to the SUPREME COURT CASE that verifies that mRNA synthetic gene modification means the vaccinated belong to the patent holder https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf