mRNA Vaccines Market - Pipeline Insights

Executive Summary

mRNA vaccines use messenger RNA (mRNA) to instruct cells in the body to produce a protein that triggers an immune response. Unlike traditional vaccines that use weakened or inactivated forms of a virus, mRNA vaccines contain synthetic genetic material that carries the instructions for the body's own cells to produce a piece of the virus, typically the spike protein found on the surface of the virus. mRNA vaccines represent a groundbreaking technology in the vaccine field, offering faster production, flexibility and the ability to target a wide range of diseases.

The COVID-19 pandemic highlighted the mRNA vaccine benefit, where the Pfizer-BioNTech and Moderna vaccines were developed in record time. Both vaccines were designed and tested within months of the virus being sequenced in early 2020, with clinical trials initiated shortly after. This rapid response was crucial for controlling the pandemic. The vaccines not only generated high levels of antibodies but also triggered a strong T-cell response, which is important for long-term immunity.

Major companies like Moderna are developing a combination vaccine targeting both COVID-19 and flu, currently in Phase III trials. The company's Phase II pipeline includes candidates for flu and respiratory syncytial virus (RSV), marking a notable expansion into bacterial pathogen vaccines. BioNTech, another key player, is leveraging mRNA technology to develop personalized cancer vaccines. The company anticipates potential approval of mRNA-based therapeutic cancer vaccines by 2030, with plans to launch its first cancer therapies starting in 2026.

List of Key Companies

The major and key players in the mRNA vaccines pipeline include

• Moderna, Inc.

mRNA-1283: mRNA-1283 is Moderna's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2.

• BioNTech SE

BNT111: BNT111 is an intravenous therapeutic cancer immunotherapy candidate encoding a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. BNT111 induces novel antigen-specific anti-tumor immune responses and enhances pre-existing immune responses against the encoded melanoma-associated antigens, which are expressed in more than 90% of cutaneous melanomas. BNT111 is one of four clinical-stage FixVac product candidates within BioNTech's development pipeline.

• Sanofi
• GSK plc
• AstraZeneca
• Merck & Co., Inc.
• F. Hoffmann-La Roche Ltd
• RinuaGene

Regulatory Designations

• In January 2025, Moderna, Inc. announced ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. This was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR).
• In November 2024, Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study Can Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.

Merger and Acquisitions

• In June 2024, Moderna, Inc. and Merck announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157).

Future Perspectives and Conclusion

The future of the mRNA vaccines pipeline looks exceptionally promising, driven by technological advances, expanding applications beyond infectious diseases and ongoing investments in research and development. One of the most exciting future applications of mRNA vaccines is in cancer immunotherapy. Personalized cancer vaccines, which are tailored to an individual's specific cancer mutations, are being actively researched. These vaccines aim to stimulate the immune system to target and destroy cancer cells.

Companies like BioNTech and Moderna are developing mRNA-based vaccines to treat cancers like melanoma. Early-stage clinical trials have shown promise, and the potential to create vaccines for a wide range of cancers holds enormous value for the oncology field.

One of the critical challenges with mRNA vaccines is the efficient delivery of the mRNA to target cells. The development of advanced lipid nanoparticles and other delivery systems is a priority to improve the stability, bioavailability and targeting of mRNA vaccines. New delivery technologies, such as self-amplifying RNA (saRNA) or nanoparticle-based systems, could allow for more efficient vaccine delivery with fewer doses and potentially more potent immune responses.

The COVID-19 pandemic demonstrated how quickly mRNA vaccines could be developed and deployed in response to a new virus. This rapid development capacity makes mRNA vaccines a valuable tool for future pandemic preparedness. Regulatory bodies are now recognizing the potential of mRNA vaccines for rapid adaptation to new infectious diseases, and frameworks for faster approval and distribution are being set in motion. This could lead to faster vaccine production during future outbreaks of diseases like Ebola, Zika, or other emerging pathogens.