The U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), an influenza vaccine developed by Moderna Inc., to prevent seasonal flu and lower risk of serious illness and complications for adults 50 years of age and older. This approval represents Moderna’s fifth approved product and the first mRNA-based influenza vaccine approved in the U.S., offering a modern respiratory vaccine option for vulnerable populations.

A New Option for Older Populations

Influenza remains a significant public health burden in the United States. During the 2024-2025 flu season, the CDC estimated 51 million influenza-related illnesses. Adults 50-64 years of age accounted for 20% of flu-related hospitalizations while patients 65 years and older made up 57% of hospitalizations and 71% of deaths. Although flu vaccines are widely accessible, the need for modern vaccine development remains high. Symptoms like high fever, body aches, fatigue, dry cough, headache, and sore throat can severely impair daily functioning and quality of life, especially in adults already experiencing health complications.

Major Steps Forward for Millions of Patients

“The approval of mFLUSIVA® marks a major step forward for millions of Americans who experience flu-related illnesses each year. We’re proud of our investigators’ contributions to this approval and excited to support a vaccine option that offers immunization to vulnerable populations.” – Rachel Hastings, Managing Partner at DelRicht Research

DelRicht Research Contributions

DelRicht Research is proud to have supported this milestone approval through the work of twelve experienced investigators and sites:

Dr. Taylor Sanders of Neighborhood Health | Prairieville, LA
Dr. Matthew Mintz of Matthew Mintz Clinic | Rockville, MD
Dr. E. Marshall Newton of Newton Family Medicine | Charleston, NC
Dr. Olabisi Badmus of Olabisi Badmus | Charlotte, NC
Dr. Jennifer Zomnir of Zomnir Family Medicine | Prosper, TX
Dr. Sean Kerby of Gulfport Memorial | Gulfport, MS
Dr. Kymberly Moyer of Magnolia Family Medicine | Hendersonville, TN
Dr. Patrick Dennis of Touro Medical Center | New Orleans, LA
Dr. Jonathan Jacobs of Concierge and Direct Primary Care | Overland Park, KS
Dr. Robert Springer of Springer Wellness and Restorative Health | Atlanta, GA
Dr. Amy Roberts of Amy Roberts MD and Associates | Town and Country, MO
Dr. Melita Tate of Grassroots Healthcare | Tulsa, OK

Together, these investigators contributed to the pivotal research that informed FDA decision-making, helping to evaluate both the safety and efficacy of mRNA-1010 in older adult populations. Their leadership reflects the strength of DelRicht’s embedded, physician-led site network model, which enables rapid enrollment and high-quality data collection across real-world patient populations.

Partnering to Move Medicine Forward

The approval of mFLUSIVA® as an influenza vaccine underscores the power of collaboration with sponsors, investigators, and site networks in accelerating therapeutic options for vulnerable populations. For families affected by influenza, this represents meaningful progress. For sponsors and CROs, it highlights DelRicht’s role as a proven partner in vaccine research, delivering both operational excellence and patient access to accelerate trial success.

To learn more about mFLUSIVA®, visit modernatx.com or read the full press release from Moderna.

Congratulations to the team at Moderna Inc., to our participating investigators, and to the many patients and families who made this approval possible.