Despite the use of various licensed vaccines, Influenza remains a huge health burden. According to a CNN news report, since the 1997-98 flu season, the Centers for Disease Control and Prevention Data records the highest number of doctor visits for flu symptoms in the United States in 2025. CDC data from October 2024 to May 2025 highlights 47-82 million people in the USA suffered from flu illnesses, with 21-37 million flu medical visits. It continues to reveal 610,000-1.3 million hospitalizations and 27,000-130,000 deaths due to this disease. As the season continues to progress, the statistics will shift dramatically in 2026, highlighting the need for modern vaccines to treat the flu.
Bringing you the latest updates from across multiple industries, including healthcare and others, with The CEO Views. We are a trusted media publication that keeps you well-informed and updated about all that’s new and all that matters to you.
This article attempts to inform you about the popular mRNA vaccine and the recent FDA review of this vaccine for treating flu illnesses in the United States. In its discussion, the article also delineates the importance of modern vaccinations like mRNA in combating flu-borne diseases.
Global Influenza Outlook
A report by the World Health Organization (WHO) has revealed that global influenza has increased since October 2025, with Influenza A dominating all viruses. Tropical areas of the world have witnessed sustained influenza activity from June through November, with influenza A(H1N1) dominating throughout July. The proportion of influenza A (H3N2) viruses among detected cases has increased since then, continuing to be a predominant virus till the end of September. Detection of Influenza in the WHO African Region increased in October, with influenza A (H3N2) being the predominant one. As of 21 November, 2025, the European region reported increased rates of influenza-like illness and/or acute respiratory infection in primary care. Influenza transmission accelerated in the southern hemisphere of America during 2025. Apart from these regions, other global regions also witnessed higher rates of flu-borne illnesses.
mRNA: The Antidote of Flu Control
The mRNA flu vaccine has been invented to deliver genetic instructions to teach cells to make harmless pieces of the virus, training the immune system to identify and fight infection while preventing the disease. A new mRNA vaccine for flu is demonstrating 34.5% more effectiveness compared to a traditional flu vaccine in preventing infection. In a clinical trial, the Pfizer-developed ‘modRNA’ vaccine to prevent illnesses caused by influenza A was tested in a trial of more than 18,000 people. The invention of this vaccine reflects the transformative power of technology in improving seasonal influenza control and preparedness for a pandemic. Developers claim that this new vaccine has milder side effects than the regular flu shot. In modRNA vaccines, some building blocks of mRNA are replaced with naturally “modified” nucleosides, such as pseudouridine. This nucleoside enables cells to communicate the message more efficiently, leading to stronger immune responses.
FDA to Review Moderna’s mRNA Flu Vaccine
As recently reported, the Food and Drug Administration (FDA) of the United States has changed its course and decided to review the new mRNA flu vaccine developed by Moderna, a US-based pharmaceutical and biotechnology company.
According to reports, the FDA sent Moderna a letter in which it refused to accept the application to review its first mRNA seasonal flu vaccine two weeks ago. This was a rare move by the federal agency, which raised concerns about another hindrance to the technology, targeted by the Trump administration’s health officials.
The FDA mentioned Moderna about the inappropriateness of its application, mentioning that it did not contain an “adequate and well-controlled” trial. This was because the control arm failed to reflect the “best available standard of care in the United States at the time of the study.”
Since then, Moderna met with the FDA to propose a “revised regulatory approach,” with different ways by age. Now, the company is “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” stated a news report. Andrew Nixon, a spokesperson from the US Department of Health and Human Services, said in his statement, “Discussions with the company led to a revised regulatory approach and an amended application, which the FDA accepted. FDA will maintain its high standards during review and potential licensure stages as it does with all products.” Stéphane Bancel, Moderna’s CEO, also said in a statement, “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review.”
If the Moderna flu vaccine gets FDA approval, it will be available for people ages 50 and older for the 2026-2027 flu season. Adding to this, the CEO of Moderna further stated, “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
