Moderna is a biotechnology company that has rapidly become a focus of global attention due to its pioneering work with messenger RNA (mRNA) technology. This platform uses genetic instructions to teach the body’s cells how to produce proteins that can trigger an immune response or treat a disease. Moderna applies this mRNA platform across a wide array of infectious diseases, cancers, and rare conditions.
Current Status of Their Core Vaccine Platform
Moderna’s primary commercial success continues to be its COVID-19 vaccine, which remains the largest source of revenue despite a shift in the global market. The product, marketed as SpikeVax, is now fully integrated into the seasonal health landscape, moving away from emergency procurement models toward standard commercial sales. This transition requires the company to adapt its product to address the constantly evolving nature of the SARS-CoV-2 virus.
The strategy involves staying ahead of dominant variants to ensure the annual shot remains effective. The company is continually testing and updating its formulations, such as the mNEXSPIKE candidate, which has demonstrated a strong immune response against variants like LP.8.1 in human trials. This focus on next-generation formulations aims to provide broader and more durable protection against circulating strains. The long-term goal is to establish a routine annual vaccination against COVID-19, similar to the seasonal flu shot.
The move toward a commercial market is supported by efforts to simplify the vaccination process. Developing a single-shot booster that covers both COVID-19 and influenza is an objective for the company. This combination approach is intended to streamline the annual immunization experience and improve overall compliance rates.
The Emerging Non-COVID Pipeline
Moderna is aggressively expanding its mRNA technology beyond the initial COVID-19 focus into a comprehensive pipeline across several therapeutic areas. This expansion includes a focus on combination respiratory vaccines, therapeutic cancer treatments, and vaccines for latent viruses. The respiratory portfolio has been bolstered by the approval of the Respiratory Syncytial Virus (RSV) vaccine, mResvia, which is designed to protect adults aged 60 and older.
The combination vaccine program is advancing with candidates like mRNA-1083, which bundles the company’s seasonal influenza vaccine with its next-generation COVID-19 vaccine into a single dose. This combination shot is aimed at capturing the established, larger seasonal flu market while simplifying the immunization schedule. Other infectious disease targets include a vaccine candidate for Norovirus (mRNA-1403), a common cause of gastrointestinal illness, which is now progressing into late-stage clinical trials.
In oncology, the company is developing therapeutic vaccines designed to train a patient’s immune system to recognize and attack cancer cells. One customized cancer vaccine, mRNA-4157, is developed in partnership with Merck. This personalized approach involves analyzing a patient’s tumor to create a vaccine specific to their cancer’s unique genetic signature. The pipeline also includes candidates targeting latent viruses, such as Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV), which persist in the body and are implicated in various long-term health issues.
Major Regulatory and Clinical Trial Updates
The company has recently achieved several major milestones while also encountering setbacks in its late-stage development programs. A regulatory success was the U.S. Food and Drug Administration (FDA) approval of the RSV vaccine, mResvia (mRNA-1345), in May 2024 for older adults. This approval marks the company’s second commercially available product and validates the platform’s potential outside of COVID-19.
Simultaneously, the combination COVID-19/flu vaccine, mRNA-1083, has delivered positive Phase 3 clinical trial results. The trial met its primary endpoints by demonstrating that the shot elicited significantly higher immune responses against both influenza strains and SARS-CoV-2 compared to standard, currently approved vaccines. These positive data pave the way for an anticipated regulatory submission for the combination shot.
However, the company recently announced the discontinuation of its congenital CMV clinical development program for the vaccine candidate mRNA-1647. The Phase 3 trial did not meet its primary efficacy goal of preventing primary CMV infection in women of childbearing age, with the efficacy against infection falling below the target range. Despite this setback, the company continues to explore the vaccine’s potential in other areas, such as preventing CMV reactivation in high-risk patients.