mRNA vaccines expand beyond Covid-19 into oncology and infectious diseases
Clinical research surges as mRNA technology shifts toward cancer treatment, rare diseases, and global health threats (Issue #335, 1000 words, 5 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
The rapid development and deployment of mRNA vaccines during the Covid-19 pandemic demonstrated the transformative potential of this technology and heralded a significant expansion into new therapeutic areas. According to the Chemical Abstracts Service (CAS) of the American Chemical Society, research output has surged, with over 8,000 journal publications on mRNA vaccines since 2020 compared to just 571 before 2019. The CAS report notes that about 70% of active mRNA vaccine trials now target diseases beyond Covid-19, reflecting a strategic shift toward oncology, infectious diseases, and genetic disorders. Johns Hopkins University attributes the shift to mRNA’s adaptability, development speed, and suitability for personalized medicine.
CAS reports that cancer vaccines represent the most advanced non-Covid-19 application, comprising 31% of mRNA vaccine trials. In a randomized Phase 2b adjuvant trial reported in The Lancet, Moderna’s mRNA‑4157 (V940), in combination with Merck’s pembrolizumab (Keytruda), reduced the risk of recurrence or death in resected stage III/IV melanoma by 44% versus pembrolizumab monotherapy. A review in Cancers found that over 120 clinical trials are underway across malignancies, with pancreatic cancer vaccines and glioblastoma treatments showing promising results. The review notes the first commercial approvals for mRNA cancer vaccines are anticipated by 2029 and are expected to advance the field of personalized oncology.
CAS also notes that infectious disease targets have diversified significantly, with influenza representing half of non-Covid-19 clinical trials for mRNA vaccines, followed by RSV, HIV, and varicella zoster. Moderna’s Phase 1/2 trial of its investigational H5 avian influenza vaccine showed positive interim safety and immune response data, though the company’s late-stage development funding from the U.S. Department of Health and Human Services was recently terminated. A report in News Medical Life Sciences notes the current mRNA pipeline includes emerging targets such as dengue, Ebola, and tuberculosis, highlighting the mRNA adaptability across a range of viral diseases.
This technology is also expected to drive significant financial growth in the industry. According to Research and Markets, market projections indicate robust growth, with the global mRNA vaccine and therapeutics sector expected to reach US$1.99 billion by 2035.
As of June 2035, Moderna leads the mRNA research field with a diversified pipeline targeting respiratory viruses, latent infections, rare diseases, and oncology. Stock Titan reports Moderna projects 2025 revenue between US$1.5 and 2.5 billion, primarily due to Spikevax and mRESVIA vaccine sales. The company expects to end 2025 with cash and investments of approximately US$6 billion. Research and Markets notes that over 45 industry players are developing mRNA candidates, with more than 170 clinical trials registered in recent years. Despite progress, manufacturing costs remain high, and delivery optimization and cold chain logistics pose a significant challenge.
THIS WEEK 06/24/25
Health Canada granted a Notice of Compliance for Novartis’ ribociclib tablets (Kisqali) in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative stage II-III early breast cancer at high risk of recurrence.
Health Canada approved Zilia’s flagship product, the Zilia Ocular, a retinal camera equipped with an optical technology that enables non-invasive measurement of oxygenation in the eye.
The U.S. FDA approved Sanofi’s dupilumab (Dupixent) for the treatment of adult patients with bullous pemphigoid.
George Medicines, a late-stage biopharmaceutical company, announced the U.S. FDA’s approval of a telmisartan, amlodipine, and indapamide combination pill (Widaplik) for the treatment of hypertension in adult patients, including as initial treatment.
NOW, LISTEN UP: HERE’S BETTINA HAMELIN OF INNOVATIVE MEDICINES CANADA
In Season 14 of the NPC Podcast, Dr. Bettina Hamelin, President of Innovative Medicines Canada, offers insights into adopting innovative technologies, the domestic pharmaceutical supply chain, and the exclusion of medicines as retaliatory measures for tariffs. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. You can listen to the podcast here.
Pamela Fralick
Executive Leader
Season 01, episode 03
Listen to this episode here
How would you advise the Canadian government or the public on creating a more conducive environment for fostering innovation in Canada? (This episode was recorded in July of 2020 when Fralick was President of Innovative Medicines Canada)
It’s all about balance. This industry fully understands that sustainability is a critical issue for the health system, and we want to be part of the solution. We recognize that governments are focused on cost containment, but we also want them to prioritize value. There is a disconnect between different arms of the government, and the issue isn’t being addressed in a comprehensive, whole-of-government way.
We have some great initiatives happening—support for innovation, a desire to see the industry thrive, and ambitions to double investments and employment. But at the same time, regulations are waiting to be implemented that could strip 70 to 80 per cent of a company’s revenue. How can you achieve both of these goals? It’s a significant challenge. So, while we can delve into the specifics, I think that’s the key takeaway for this podcast.
NEXT WEEK
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