Normally the new vaccine review process with FDA is a boring technical slow process. Up til now, the only people who understood the process and followed it were public health specialists, immunologists mainly in med school faculties, and their vaccine research counterparts inside industry research labs. Not any more.
The standard flu vaccine is old and primitive by comparison with the mRNA covid vaccines. The standard flue vaccine must be reformulated every year based on field sampling mainly in China where the new strain of influenza begins to appear every year about six months before vaccine makers must market their new years flue vaccine. That means every year the small number of companies who attempt to market this old style vaccine for the new flu season are always taking a chance that their new mixture of flu virus strains in the vaccine many not really target the actual new strain of flue that will be infecting their expected populations later in that same year. This means there are years where the current vaccine is mostly ineffective against the actual strains in circulation. To make things worse, the history of influenza yearly outbreaks has occasions when a new strain of virus proves to be very deadly. This virus strain shifting makes deciding which strains to include in the new years vaccine a high stakes choice. Normally, in the USA, this decision process is collaborative between manufacturers, and their regulator, the FDA.
This year the FDA has become non collaborative in my unprofessional opinion. I am not an immunologist, and only worked peripherally with the flu vaccine group at my former employer, and that was decades ago. I would hear about this flu strain selection process in informal discussions within the production lab. I should also point out that flu vaccine was never a "money maker" in the context of large scale of manufacturing, nor high profitability. Making the flu vaccine was seen as a public health duty within that company. Essentially all of the product produced was bought by a small number of government health agencies, there never were any patent protections on that vaccine, and there was nothing high tech or limiting in the technology used. Most commercial producers did not advertise or promote their role in its manufacture. Because the vaccine was a so called killed virus type, there were almost always reactions to the shot which were actually caused by the chemical in the vaccine used to kill the virus. The reactions were caused by that preservative, not the killed flue virus. Most reactions were a sore arm, and fatigue normally for a day or two.
Why is an mRNA flu vaccine possibly very useful? Because in the mRNA process, the manufacturer has the ability to modify or adjust the active component of the vaccine quickly, and precisely. The process is presicely adjustable, while the old style flu vaccine is not. It takes months to reconfigure the flu virus content in the old vaccine. It's also very expensive to go back and start over with a modified strain. Moderna in the USA, and BionTech in Germany are currently the only companies who have mastered the mRNA vaccine process. These two companies changed their whole research and production focus to design and produce an effective Covid vaccine. They were successful, and briefly given I would say a limited amount of recognition. Neither company made a fortune on their gamble to produce the mRNA Covid vaccine, and both companies faced serious negative publicity during and after the pandemic.
Both of these vaccine companies are focused on developing cancer tumor vaccines, which would be eligible for patent protection and would carry very very high prices that are common place in all innovative serious cancer therapies. Last point, both Moderna and Bion Tech (which is marketed by Pfizer in the States) are not large multinational multi product companies. They are small to medium sized firms focused on cancer treatment innovation. This sort of very public wrangling with Washington bureaucrats can easily cause a company to exit the public health vaccine world.
Moderna held further discussions with regulators and announced that the agency would accept the company's application for approval of its flu vaccine that uses mRNA technology.
F.D.A. Reverses Decision and Agrees to Review Moderna's Flu Vaccine
Christina Jewett and Rebecca Robbins
The New York Times February 18, 2026
The Food and Drug Administration reversed course and agreed to review Moderna's mRNA-based flu vaccine for possible approval, just one week after rejecting the company's application on the grounds that its study design was flawed.
Following further discussions, Moderna agreed to split its application by age group — seeking standard approval for adults 50 to 64 and accelerated approval for those 65 and older, along with a commitment to conduct an additional post-market study for the older age group.
The F.D.A. set an August deadline to decide on approval; if authorized, the vaccine could be available before the next flu season.
Moderna's study found the vaccine safe and effective across age groups, with mostly mild side effects, though side effects were more frequent and severe in those under 65 and more pronounced than with the comparison vaccine.
No mRNA-based flu vaccine has been approved anywhere in the world; regulators in Europe, Canada, and Australia are also reviewing Moderna's application. The dispute drew broad industry concern, as the F.D.A. has recently rejected or refused to review several other drug applications, unsettling pharmaceutical companies and investors.
"What we can't have is somewhat arbitrary changes to those rules after the game has been played." — Dr. Stephen Hoge, Moderna's President
"The F.D.A. decision now to review Moderna's flu vaccine is absolutely right for continued American biotech innovation. The past week highlights the need for greater consistency and predictability from the F.D.A. if we want to ensure that the U.S. remains the world leader in biomedical research." — John F. Crowley, President, BIO
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