Russia is on its way to introduce its personalised mRNA-based cancer vaccine called Enteromix which has reportedly shown 100 percent efficacy and safety in early-stage clinical trials. The country's Federal Medical and Biological Agency (FMBA) announced last week that the vaccine not only proved to be safe but also showed powerful tumour-fighting abilities. Sputnik, a global wire and digital news service from Russia on September 7 posted on X: “The Russian Enteromix cancer vaccine is now ready for clinical use, the Federal Medical and Biological Agency (FMBA) has announced.”
At the Eastern Economic Forum (EEF), held between September 3 and 6, Veronica Skvortsova, head of Russia’s FMBA, stated that the Enteromix vaccine is personalised for each patient, designed using their unique RNA profile. The first version of the vaccine, awaiting approval, is aimed at treating colorectal cancer—one of the most prevalent and lethal cancers globally. Preclinical trials showed that the vaccine significantly reduced tumour size and slowed their progression.
It was also proven safe for repeated administration, is built on technology similar to Covid-19 mRNA vaccines, and is said to work without the harsh side effects of chemotherapy or radiation. Research is also progressing on additional variants of the vaccine, including those targeting glioblastoma, an aggressive and often fatal brain tumour, and specific forms of melanoma such as ocular melanoma. These developments could mark a major breakthrough in precision cancer therapy.
Enteromix was developed by Russia’s National Medical Research Radiology Centre in collaboration with the Engelhardt Institute of Molecular Biology under the Russian Academy of Sciences. It was publicly unveiled at the St Petersburg International Economic Forum (SPIEF 2025), showcasing Russia’s latest biotech innovations. Built on mRNA technology—previously used in Covid-19 vaccines—Enteromix trains the immune system to identify and attack cancer cells. It uses a combination of four harmless viruses to target tumours while activating immune defences. After years of preclinical testing, the vaccine has shown the ability to slow tumour growth and, in some cases, eliminate tumours entirely with its Phase-1 trials which began in June 2025 with 48 volunteers. The vaccine is awaiting regulatory approval, and if cleared, could become the world’s first personalised cancer vaccine, offering tailored treatment and potentially transforming global cancer care.
Russia is not alone in the race to develop cancer vaccines. Biotech companies around the world, including BioNTech in Germany, Moderna in the US, and CureVac are actively testing personalised mRNA vaccines for cancers such as pancreatic, melanoma, and lung. Some of these firms have already reached Phase II or III clinical trials, giving them a lead in terms of data maturity and potential regulatory approvals in key markets like the EU and US. Two US cancer vaccines are reportedly under trial and will seek regulatory approval by end of 2026. Where the Russia vaccine is concerned, while Phase 1 results are promising, the vaccine needs to undergo larger, multi-center Phase 2 and Phase 3 clinical trials to confirm its effectiveness and safety in a broader population.
The UK’s National Health Service has also launched the world’s first large-scale trial of personalised cancer vaccines under its Cancer Vaccine Launch Pad, with the goal of treating thousands of patients by 2030. Unlike preventive vaccines, these are designed to help the immune system identify and destroy existing tumours.
India is also making notable strides with the government preparing to roll out a vaccine targeting breast, oral, and cervical cancers for girls aged 9–16, as announced by the Union Minister of State for Health, Family Welfare in February 2025. In addition, India has developed an affordable HPV vaccine to prevent cervical cancer, which affects millions of women nationwide.
Despite Russia’s leads in vaccine development, global uptake of its vaccines, especially its Covid-19 vaccine Sputnik V, has remained limited due to a combination of scientific, logistical, and political factors. One major issue has been the lack of transparency. Sputnik V was approved before completing Phase III trials, raising concerns among international regulators and scientists about its safety and efficacy. This premature approval, coupled with delayed data sharing, hindered acceptance by bodies like the WHO and the European Medicines Agency. Even in Russia, vaccine hesitancy was high with only about 34 percent of the population willing to take Sputnik V at one point.
In India, the vaccine faced similar hurdles. Despite a partnership between Dr Reddy’s Laboratories and Russia’s RDIF, Sputnik V accounted for less than 1 percent of total vaccinations. The rollout was hampered by cold storage requirements, delayed regulatory approvals, and poor yields of the second dose. Moreover, with Covishield and Covaxin dominating the market and being offered free by the government, Sputnik V, which was priced higher and available only in private hospitals, struggled to find demand.
Countries in Latin America, Africa, and Southeast Asia too initially embraced Sputnik V, but later faced delivery shortfalls and turned to alternatives.