Touted as a game changer, a holy elixir and a superlative amongst its therapeutic counterparts, the mRNA cancer vaccine and its launch by Russia has sparked a series of debates in the healthcare realm. The lack of clinical validation has irked the scientific community to rethink the exaggerated claims, given that developing mRNA cancer vaccines is a long and challenging process.
Russian scientists have supposedly arrived at a groundbreaking revelation - a vaccine candidate that can cure cancer. While studies on this modality of immunotherapy were initiated in the 1960s, clinical trials ensued in the early 2000s and today the world has opened up to the breaking news of an mRNA vaccine that can suppress tumour development and metastasis.
Dr Amit Upadhyay, Senior Consultant, PSRI Hospital elaborated on the mode of action of the mRNA cancer vaccine that has been making news worldwide. “These decode a type of protein usually associated with cancer. We inject that into the body, and the body reprograms the immune cells against this type of peptide, which is usually expressed by cancer cells so that our immunity gets redirected towards cancer and fights against it. That is the basis of mRNA-based vaccines.”
Keeping pace with the new era of medicine 4.0 that demands personalisation, the vaccine can be custom-made to suit an individual's tumour characteristics. “These are very personalised vaccines, quite effective, and have the potential to be game-changers,” opined Dr Upadhyay.
Reports claim that AI will be used to assess the tumour characteristics of the patient, beyond which a customised blueprint of the vaccine will be created, with the usable form of the vaccine being available within a week.
Scientific community - Playing the devil's advocate
Industry experts are divided over these lofty claims by Russia. The cancer vaccine, a brainchild and collaborative effort of three research centres claims to be a ubiquitous vaccine for all forms of cancer.
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Industry experts are divided over these lofty claims by Russia
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Dr Roshan Dikshit, Senior Consultant, Haematology & Bone Marrow Transplant, Aakash Healthcare, however, thinks otherwise, “A single cancer vaccine for all cancers is a utopia. Although ideal, it’s not a viable option since the mutational profile and genetic signature of every cancer are different. A targeted and effective mRNA vaccine for a specific cancer can be a game changer. But we are far from getting it for all cancers.”
The devil is in the details and so do industry experts think, they claim that there are gaps in evidential data which makes the announcement almost sound like a farce. The lack of factual data and a stark deviation in preclinical trials and human trials expose the untold truth of this innovative technology.
The Missing Link - Clinical Trials
Clinical trials form the basis of any medical advancement, they offer a window into the functionality and safety of the drug or therapy in question. The scientific community has been dubious about the factuality of clinical trials in the mRNA cancer vaccine.
Dr Upadhyay shed light on the advancements made in animal studies. He expressed optimism around the furore over the clinical trials in the mRNA vaccine stating that animal studies in recent times have been encouraging, unlike previously when the sample size of human populations used to be much smaller leading to inconsistent results. This in turn led to distrust in product/drug efficacy.
“But of late, we have better drug delivery methods and better vectors that can deliver the medicine precisely. So now, things are probably getting better, and hopefully, we should see some good responses coming. There is a lot of research and many trials going on, with very good early results in some. Let’s wait for the final results. Hopefully, we’ll get something soon,” said Dr Upadhyay.
Tricking the tumour- The obstacle course
Digging deeper into the working mode of action of the mRNA cancer vaccine reveals a typical situation of obstacle racing. Dr Upadhyay went on to explain the significant challenges in the development of an mRNA vaccine for cancer, stating that the development of a cancer vaccine may not be as easy as it seems.
“The most important one is how to deliver the vaccine precisely to the immune system. The second challenge is how to regulate the expression of that protein. We have to deliver it precisely to those immune cells where we want it and not to places where we don’t. Additionally, we need to regulate the expression of that protein so that it does not go overboard. That remains a very significant challenge. The third issue is that cancer cells can be a very heterogeneous population.”
“There are many subpopulations of cancer cells that may produce proteins specific to the cancer but may not necessarily be pathogenic or causing disease. So, identifying the proper pathogenic protein, delivering it via mRNA vaccines, and making sure it reaches the right place—where the body should produce the immune response in exactly the right quantity—is still a very technologically challenging task,” said Dr Upadhyay.
Dr Dikshit has also expressed pessimism over these exaggerated claims of Russia arriving at a novel mRNA cancer vaccine. “It does seem far-fetched that a single product can be aimed for all cancers.”
Exploring the uncharted- India
The mRNA technology has emerged as an effective form of immunotherapy, however, this has remained uninitiated in the Indian subcontinent. India is yet to evaluate and investigate the tremendous potential of this therapeutic modality and industry insiders claim that this may require immense groundwork, vision and foresightedness to establish ourselves as a manufacturing hub for cancer vaccines.
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The mRNA technology has emerged as an effective form of immunotherapy, however, this has remained uninitiated in the Indian subcontinent
Dr Dikshit gave his candid opinion on India exploring this breakthrough technique in curbing cancer. “We need quality laboratories and coordination of pharmaceutical companies and clinicians with support from our government to have a home-grown cancer vaccine in the future.”
“India has the potential, but we are not currently focused on developing mRNA vaccines. The research capabilities required would include a strong foundation in genetic research, advanced drug delivery systems, and the ability to handle large-scale clinical trials to ensure the efficacy of the vaccines. Investment in infrastructure for biotech research and collaborations with global players in the field will also be crucial,” stated Dr Upadhay.
Dr Upadhay laid out a vivid and all-encompassing blueprint that would be essential to improve India's research capabilities with respect to such advancements in research. “India would need significant advancements in biotech infrastructure, including specialised labs for genetic research, facilities for large-scale vaccine production, and state-of-the-art drug delivery technology. The country would also need to invest in training and retaining top-tier researchers in genetics, immunotherapy, and mRNA technology. Additionally, funding for clinical trials and the regulatory framework to fast-track approvals would be essential.”
Dr Niti Raizada, Principal Director of Medical & Hemato Oncology, Fortis Hospitals, Bengaluru hinted at a very key aspect, which is that research and clinical trials in such advanced technologies tend to be capital intensive. She further added that trials often tend to be more unsuccessful than successful, making this process highly capital-intensive.
Until India gears up to roll out and embrace this technology that has proved to show remarkable results for cancer, we will have to play a waiting game till then to see how the new mRNA cancer vaccine by Russia plays out in the real world.
The world is in dire need of these groundbreaking therapies that can salvage millions of lives from this deadly disease. The future of cancer care lies in revolutionary cancer vaccines that can target heterogeneous tumours and circumvent immune evasion.
Nevertheless, this announcement by Russia is a head start to the bigger picture, the ultimate cure for cancer - a monumental breakthrough!
