The FDA Does a Very Good Thing

By John R. Puri

Thursday, August 06, 2026

 

Despite what RFK Jr. says, mRNA-based vaccines have the potential to be groundbreaking. It came as a pleasant surprise this morning to see that one more will soon be available, with possibly lifesaving consequences.

 

From the New York Times:

 

The Food and Drug Administration on Wednesday approved the first mRNA flu vaccine, enabling use of a technology that will make it easier to rapidly target a widely prevalent or particularly virulent strain of the virus.

 

The vaccine, developed by Moderna, proved more effective than flu vaccines currently on the market in clinical trials:

 

The company enrolled nearly 41,000 people who were 50 to 64 years old in a major study that found that the vaccine was effective but had more side effects than a vaccine manufactured with older technology. In the study, about 21,000 people took the Moderna vaccine and about the same number took the comparator vaccine. Within six months, 411 of the Moderna recipients got the flu compared with 557 of those who took the other flu shot. That translated to a relative efficacy of about 27 percent.

 

There are drawbacks, unfortunately, as with any alternative drug. Those taking Moderna’s vaccine were twice as likely to experience minor side effects, such as injection-site pain, fatigue, and headache. Out of 21,000 recipients, there were three cases of serious medical reactions linked to the shot. (None resulted in death.)

 

These are risks worth considering against the benefits of increased immunization. But they are far better considered by doctors and patients, on a case-by-case basis, than by bureaucrats who make a one-size-fits-all determination. The FDA’s job is to ensure a baseline level of safety and efficacy and then allow individuals to judge for themselves. Approving the vaccine was the right call — especially because it sets the precedent that future mRNA drugs, targeting much worse diseases than the flu, will get a fair shake.

 

Incredibly, however, Moderna’s application almost didn’t receive even a cursory review:

 

Initially the F.D.A. had refused to even review Moderna’s application for approval earlier this year, but quickly reversed course after a public outcry. The flu kills more than 300,000 people worldwide each year and was particularly harsh in the 2024-25 season, with an estimated 45,000 deaths in the United States, including at least 297 reported cases in children, according to the Centers for Disease Control and Prevention.

 

That decision “came from the desk of Dr. Vinay Prasad, who at the time was the head of the agency’s vaccine division.” He isn’t there anymore. Amazing things can happen when Bernie Sanders acolytes step away from regulatory positions.

 

As for why Prasad held such an important job in the first place, we can thank the boss at the Department of Health and Human Services. Hopefully no one has told him about the Moderna approval.