A groundbreaking flu vaccine using mRNA technology has shown significantly better results than traditional shots in a comprehensive clinical trial involving more than 40,000 participants aged 50 and above, according to research published Wednesday.
The experimental vaccine from Moderna demonstrated 26.6% greater effectiveness compared to GSK’s conventional standard-dose flu vaccine, surpassing the study’s primary objective of proving non-inferiority to existing immunizations.
Federal regulators are currently evaluating the vaccine application, with a final determination anticipated by August 5th. If given the green light, this would mark the first seasonal influenza vaccine in America utilizing mRNA technology, which offers faster development capabilities than traditional manufacturing approaches.
However, the approval process faces additional challenges under Health Secretary Robert F. Kennedy Jr., who has expressed strong opposition to mRNA platforms. Kennedy, known for his anti-vaccine stance, has eliminated hundreds of millions in research funding and made unsubstantiated claims about the technology.
“These findings support the role of mRNA-1010 in improving influenza prevention,” stated Dr. Isabel Leroux-Roels from Ghent University and her research team in their publication in the New England Journal of Medicine.
The study revealed that participants receiving the mRNA vaccine experienced more frequent side effects, including pain at the injection site, tiredness, headaches, and muscle soreness, compared to those getting standard shots. However, most reactions were classified as mild to moderate and resolved quickly.
Serious adverse events occurred at similar rates between both groups, affecting 2.2% of mRNA vaccine recipients versus 1.9% of those receiving the conventional vaccine. Researchers noted that overall safety profiles aligned with previous large-scale trial results.
The FDA initially declined Moderna’s application in February, questioning the company’s choice to compare against a standard-dose vaccine rather than the high-dose formulation typically recommended for Americans 65 and older due to its superior effectiveness.
Following discussions between the company and regulators, the agency accepted a revised application with Moderna’s commitment to conduct additional studies in elderly populations after approval.
International regulatory authorities in the European Union, Canada, and Australia are also reviewing the vaccine. Meanwhile, European officials approved Moderna’s combination mRNA vaccine targeting both influenza and COVID-19 in April.
