FDA Approves First mRNA Flu Vaccine
The mFlusiva vaccine is intended for people over 50 and marks a milestone in applying mRNA technology beyond the fight against COVID-19.
The mFlusiva vaccine is intended for people over 50 and marks a milestone in applying mRNA technology beyond the fight against COVID-19.
The U.S. Food and Drug Administration (FDA) on Tuesday, August 5, 2026, approved Moderna's flu vaccine for people over 50, the company announced. This is the first approval of a vaccine based on messenger RNA (mRNA) for seasonal flu, marking a significant breakthrough for a technology that gained global fame during the COVID-19 pandemic.
The vaccine, named mFlusiva, received traditional approval for adults aged 50 to 64, while for those over 65, it was approved under an accelerated pathway. Moderna has committed to conducting additional trials and providing more data for that older age group to confirm the vaccine's benefit.
The approval is based on data from a late-stage clinical trial involving more than 40,000 adults over 50. Results showed the vaccine was 26.6 percent more effective than a standard licensed flu vaccine. The company also submitted separate data showing that mFlusiva generated a stronger antibody response than competitor Sanofi's high-dose flu vaccine in adults over 65.
Unlike conventional vaccines, which are primarily egg-based and contain viral proteins, Moderna's vaccine uses mRNA technology. It prompts the body to produce influenza antigens itself and triggers an immune response. This approach potentially allows for faster vaccine updates to match circulating strains.
"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for older Americans," Moderna said in a statement.
mFlusiva will compete in the market with flu vaccines from Sanofi, GSK, CSL Seqirus, and AstraZeneca. Analysts, however, do not expect significant revenue from the vaccine before the second half of 2027, as Moderna missed the contracting cycle for the 2026 U.S. flu season. Jefferies, an analytics firm, projects that sales of Moderna's flu vaccine and its combined COVID-flu vaccine in the U.S. could reach $750 million (approximately SGD 960.27 million) by 2030.
Moderna has been counting on this vaccine and a future combination vaccine to offset some of the lost revenue from its COVID-19 vaccine and to prove the long-term commercial potential of its mRNA technology, which has faced pushback from some U.S. health officials.
The path to approval was not entirely smooth. In 2025, Moderna withdrew its application for a combined COVID-flu vaccine after the agency requested additional evidence on the efficacy of the flu component. That withdrawal came amid heightened FDA scrutiny of vaccines under previous leadership, drawing criticism from industry and public health experts.
Earlier in 2026, former FDA Commissioner Marty Makary and former vaccine chief Vinay Prasad were forced to resign amid controversies over reviews of vaccines and rare disease drugs, including Moderna's flu vaccine application. Acting Commissioner Kyle Diamantas has since sought to stabilize the agency and rebuild industry trust.
