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Moderna RSV Vaccine Nears FDA Approval

  //food-wine.news-articles.net/content/2026/02/19/moderna-rsv-vaccine-nears-fda-approval.html
  Published in Food and Wine on Thursday, February 19th 2026 at 3:18 GMT by Action News Jax
      Locales: Florida, Maryland, Massachusetts, UNITED STATES

JACKSONVILLE, Fla. - February 19th, 2026 - Moderna is on the cusp of a significant public health breakthrough with its mRNA-1345 vaccine for Respiratory Syncytial Virus (RSV). The company anticipates a positive endorsement from the Food and Drug Administration (FDA) advisory panel this week, potentially paving the way for a new era in RSV prevention, particularly for vulnerable populations like older adults and infants.

For decades, RSV has posed a persistent challenge to healthcare professionals and families. This common respiratory virus, while often causing mild, cold-like symptoms, can lead to severe complications - bronchiolitis and pneumonia - especially in infants and the elderly. Prior to recent advancements, options for prevention were limited, largely revolving around supportive care and preventative measures like handwashing and social distancing. The development of a highly effective vaccine has long been a goal for researchers.

Moderna's mRNA-1345 represents a novel approach to RSV vaccination. Leveraging the messenger RNA (mRNA) technology that proved so successful with COVID-19 vaccines, Moderna's candidate instructs the body's cells to produce a harmless piece of the RSV virus, triggering an immune response without exposing individuals to the actual virus. This method has demonstrated a favorable safety profile in clinical trials, crucial for vaccines targeting vulnerable demographics.

According to Moderna CEO Stephane Bancel, the company feels "very well-positioned to meet the needs of older adults." This focus on the 65+ population is strategically important. Older adults are at heightened risk of severe RSV illness, often requiring hospitalization and contributing to significant morbidity and mortality, particularly those with underlying health conditions like heart disease or chronic lung disease. Current estimates suggest that RSV causes approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among adults 65 years and older each year in the United States.

While the initial focus appears to be on older adults, the implications of Moderna's RSV vaccine extend to infants. The FDA is also expected to review data on potential maternal immunization strategies, where pregnant individuals would receive the vaccine, passing antibodies to their unborn child, providing early protection after birth. This approach is crucial as infants are uniquely susceptible to severe RSV illness during their first few months of life, before their immune systems are fully developed. Existing preventative measures for infants, such as the monoclonal antibody nirsevimab, offer temporary protection, but a vaccine offers the potential for longer-lasting immunity.

Experts predict the FDA will give significant weight to the advisory panel's recommendation. The panel, comprised of independent medical and scientific experts, rigorously reviews clinical trial data, assessing the vaccine's efficacy, safety, and manufacturing quality. A positive vote is a strong indicator of likely approval. However, it's important to remember that the FDA is not bound by the panel's advice and will make its own independent determination.

The clinical trial results supporting mRNA-1345 have been promising. While specific efficacy numbers are subject to ongoing analysis and publication in peer-reviewed journals, Moderna has consistently reported strong results indicating significant protection against RSV-related illness. The company has also emphasized the vaccine's generally mild side effect profile, further bolstering its appeal.

If approved, the Moderna RSV vaccine is expected to be administered annually, similar to the flu vaccine, due to the potential for waning immunity and the continuous evolution of the virus. The logistical challenges of widespread vaccination, including manufacturing, distribution, and equitable access, are already being addressed by Moderna and public health officials. Furthermore, widespread vaccination could potentially reduce the overall burden of RSV, lessening the strain on healthcare systems during peak season.

Beyond Moderna, several other pharmaceutical companies are also developing RSV vaccines and monoclonal antibodies, creating a competitive landscape. However, Moderna's pioneering use of mRNA technology places it at the forefront of this emerging field, offering a potentially transformative approach to combating this widespread respiratory virus. The anticipated FDA decision marks a pivotal moment in the fight against RSV and offers hope for a future where the risk of severe illness from this common virus is significantly reduced.