Moderna, a biotechnology company, rose to global prominence by developing its messenger RNA (mRNA) technology, which was foundational to one of the first authorized vaccines against COVID-19. The company’s work continues to advance with ongoing developments in vaccine technology and other therapeutic areas.
COVID-19 Vaccine and Booster Updates
Moderna’s COVID-19 vaccine, Spikevax, continues to be a focus of public health, with regulators providing updated recommendations based on current viral trends. The U.S. Food and Drug Administration (FDA) approved a new formulation, mRNA-1283 (marketed as mNEXSPIKE), for adults 65 and older, and for individuals aged 12-64 with high-risk health conditions. This updated vaccine is expected for the 2025-2026 respiratory virus season.
In a shift from universal vaccination, advisory committees are moving toward more targeted recommendations. The Centers for Disease Control and Prevention (CDC) advises that most adults aged 18 and older receive a 2024-2025 COVID-19 vaccine, with an emphasis on those over 65 or at high risk. For children, the CDC recommends parents discuss vaccination with a healthcare provider. This approach reflects a transition toward managing COVID-19 with population-specific guidance.
The approval of mNEXSPIKE was supported by a Phase 3 clinical trial involving approximately 11,400 participants. The study showed the new vaccine had a similar safety profile to the original Spikevax but with fewer local side effects like injection site pain. The FDA has also mandated expanded warning labels for both Moderna’s and Pfizer’s mRNA vaccines regarding the rare risk of myocarditis and pericarditis, primarily in males aged 16 to 25.
Future updates to COVID-19 vaccines for the general healthy population between 6 months and 64 years will require new randomized, placebo-controlled trials. This policy change means routine vaccine updates will first be available to seniors and other high-risk groups.
Advancements in the Product Pipeline
Moderna is expanding its product offerings beyond its COVID-19 vaccine, with several candidates in late-stage development and a focus on respiratory illnesses. The company’s vaccine for respiratory syncytial virus (RSV), mRESVIA (mRNA-1345), received regulatory approval in 2024 for adults 60 and older. Following positive Phase 3 data in high-risk adults aged 18-59, Moderna has filed for expanded approval with the FDA.
The company is also developing combination vaccines to simplify immunization schedules. Its combined flu and COVID-19 vaccine, mRNA-1083, has shown positive Phase 3 data in adults 50 and older, and regulatory filings have been submitted. This combination could appeal to the large number of individuals who already receive an annual flu shot. A standalone seasonal flu vaccine, mRNA-1010, is also in a two-season Phase 3 efficacy study, with initial data anticipated in 2025 if enough cases are recorded.
Beyond infectious diseases, Moderna is progressing in oncology. The company is collaborating with Merck on a personalized cancer vaccine (PCV), mRNA-4157, designed to work with Merck’s Keytruda. This therapy aims to stimulate a patient’s immune system to target tumor-specific mutations. A Phase 3 trial for the adjuvant treatment of melanoma has completed enrollment, and the program has expanded into studies for other tumor types, including lung cancer.
The individualized neoantigen therapy has shown a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death in patients with high-risk melanoma in a Phase 2 study.
Key Financial and Corporate Updates
Moderna’s financial landscape reflects its transition from the peak of the pandemic. In the first quarter of 2025, the company reported total revenues of $108 million, a decrease from $167 million in the same period of the previous year, due to lower sales of its COVID-19 vaccine. This resulted in a net loss of approximately $1.0 billion for the quarter.
Despite the decline in revenue, Moderna reaffirmed its 2025 sales guidance of $1.5 to $2.5 billion and announced cost-saving measures. Research and development expenses for the first quarter of 2025 were $856 million, a 19% decrease from the prior year. The company’s cash position remains substantial at $8.4 billion, providing a foundation for its ongoing pipeline development.
The performance of Moderna’s stock (MRNA) has shifted from being driven by vaccine sales to being more closely tied to news about its product pipeline. For the first quarter of 2025, Moderna reported a loss per share of $2.52, which was better than analyst expectations.
Looking ahead, the company’s financial performance will be influenced by the commercialization of new products like its RSV vaccine and potential combination vaccines. The next earnings report is anticipated on July 31, 2025, which will provide further insight into the company’s financial trajectory.
mRNA Technology Platform Expansion
Moderna is leveraging its messenger RNA platform to explore applications beyond infectious disease vaccines. The company is investigating how this technology can address conditions including rare genetic diseases, autoimmune disorders, and cardiovascular diseases.
One area of research is in rare diseases. Moderna is collaborating with Vertex Pharmaceuticals to develop a treatment for cystic fibrosis (CF) delivered to the lungs via an aerosolized lipid nanoparticle (LNP) formulation. The goal is to use mRNA to instruct lung cells to produce a functional version of the CFTR protein. The companies have completed studies that support moving this program into clinical development.
To foster innovation, Moderna has also launched programs like mRNA Access, which allows researchers at partner institutions to use its platform to develop medicines for neglected and emerging infectious diseases. This initiative is part of the company’s broader effort to accelerate new treatments and prepare for future public health challenges.