What independent, peer-reviewed data exist about Enteromix or Russia’s cancer vaccine trials?

Checked on January 27, 2026
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Executive summary

Russia’s vaccine-efficacy">Enteromix vaccine has been publicly touted by Russian agencies and state-linked media as showing dramatic preclinical and very early clinical success, including claims of 100% efficacy and tumor regressions in small cohorts [1] [2] [3]. Independent, peer‑reviewed primary data validating those claims, however, are not available in the scientific literature as reported by international fact‑checks and independent commentators [4] [5] [6].

1. What the Russian announcements actually claim

Russian officials and institutions — notably the Federal Medical and Biological Agency (FMBA) and the National Medical Research Radiological Centre together with the Engelhardt Institute of Molecular Biology — have described Enteromix as a personalized mRNA/oncolytic vaccine that completed preclinical testing and entered small human studies, with reported reductions in tumour size of 60–80% in some patients and an initial clinical cohort of about 48 volunteers [7] [3] [2]. These claims were promoted at public venues such as the St. Petersburg and Eastern Economic Forums, and picked up widely by domestic and international press [8] [1].

2. What independent, peer‑reviewed data exist

A search of the reporting compiled here finds no independent, peer‑reviewed primary publications presenting Enteromix preclinical or clinical datasets; experts quoted in international coverage and an AFP fact check explicitly say they “can find no peer‑reviewed academic evidence” of human clinical trial data for Enteromix [4] [5]. Independent scientific reviews and commentary pieces summarizing available claims do appear (for example a ResearchGate/third‑party review and a journal special issue summarizing the program), but those sources themselves note the absence of transparent, peer‑reviewed trial reports and label the evidence as preliminary rather than conclusive [9] [10] [6].

3. How independent sources assess the quality of the evidence

Independent analysts and clinicians cited in international articles stress that Phase I trials with small sample sizes (e.g., ~48 patients) primarily assess safety and are insufficient to claim broad efficacy, and that Phase II/III trials with larger, diverse cohorts plus peer‑reviewed reporting are essential to validate safety, efficacy and durability [4] [5] [2]. Fact‑checking organizations flagged social media exaggeration of Russian press claims — particularly the “100% cure” framing — and emphasised the need for transparent datasets and international peer review before clinical use can be endorsed [4] [11].

4. Where the publicly available material falls short

Public reports consist largely of governmental press statements, media summaries, and reviews that compile claimed outcomes but do not supply underlying data, methodology details, statistical analyses, or independent replication — the core elements expected in peer‑reviewed publication [8] [1] [6]. Even review articles and conference summaries that describe Enteromix repeatedly note the lack of primary journal articles and call for multicenter trials and open data sharing before wider adoption [9] [10].

5. Competing narratives and potential agendas

The coverage shows two competing dynamics: Russian agencies and domestic press promoting a national scientific breakthrough and quick implementation, including promises of free access, and international scientists and fact‑checkers urging caution and demanding peer‑reviewed evidence [3] [6] [4]. The timing of announcements at high‑profile economic forums and the prominence of state institutions suggest a public relations as well as scientific dimension to the messaging [8] [1].

6. Bottom line and what would change the assessment

As of the sources compiled here, there are no independent, peer‑reviewed primary data published in scientific journals that confirm Enteromix’s claimed clinical efficacy; available material is limited to governmental statements, media reports, and secondary reviews that themselves call for robust, peer‑reviewed Phase II/III evidence and transparent data sharing [4] [5] [9] [6]. The assessment would change decisively if investigators publish full trial protocols, datasets and analyses in reputable, peer‑reviewed journals or register and report larger randomized trials with accessible results.

Want to dive deeper?
What peer‑reviewed mRNA cancer vaccine trials (e.g., BioNTech, Moderna) have published Phase II/III results and what do they show?
How do regulatory agencies (EMA, FDA, WHO) evaluate evidence from small Phase I cancer vaccine trials before granting broader authorization?
What are the standards for independent replication and data transparency in reporting early‑stage oncology vaccine trials?