In just the most recent strike of the Trump administration’s war on drug development — commanded by our crackpot HHS secretary, Robert F. Kennedy Jr. — the drugmaker Moderna announced yesterday that the Food and Drug Administration is refusing to even review its application for a new influenza vaccine.
Moderna made its name pioneering the application of mRNA technology, becoming one of two firms (the other being BioNTech) to develop the first-ever mRNA vaccines for Covid-19. Moderna has always been dedicated to exploring mRNA, an innovative method of training one’s cells to produce antibodies that fight a given disease. Heck, the company’s stock ticker is MRNA.
As sales of Covid vaccines have subsided alongside the pandemic, Moderna has sought to diversify its product line. In 2024 — the last year before the Trump administration — it won FDA approval for the first non-Covid mRNA vaccine, targeted at respiratory syncytial virus (RSV) in older adults. After that, the most developed vaccine in Moderna’s pipeline was an mRNA-based update to the seasonal flu vaccine. The immunization has now completed Phase 3 trials, typically the final stage of study before FDA approval or denial, and saw very strong results.
Unfortunately, the secretary of HHS, which oversees the FDA, absolutely despises mRNA technology for no coherent reason besides his own crankery. That is why, last year, Kennedy canceled $500 million in research grants for mRNA vaccines against infectious diseases, shifting the funding to older and less effective vaccine types. And it is why Vinay Prasad, the director of the FDA’s vaccine division and one of Kennedy’s progressive disciples, has decided to stonewall Moderna’s application.
From the Wall Street Journal:
The FDA sent Moderna a “refusal-to-file” letter earlier this month, saying the company’s study testing the vaccine wasn’t sufficient, and the agency wouldn’t take up the company’s request for approval to sell the shot, Moderna said Tuesday.
In the letter, the FDA said Moderna failed during testing to compare its experimental flu vaccine with the best available vaccine on the market.
In fact, Moderna tested its vaccine against a quadrivalent inactivated influenza vaccine, the standard type of vaccine taken by 90 percent of Americans who receive any flu shot at all. In the Phase 3 study, Moderna’s vaccine reduced flu cases by 26.6 percent versus the comparator and exhibited no safety concerns.
Again from the WSJ:
Moderna said the FDA didn’t raise any objections about the adequacy of Moderna’s trial before the study started in 2024. After the study was completed, Moderna had a meeting with the FDA in August 2025, and provided additional data requested by the agency. The company said the FDA never indicated it would refuse to review the application.
Based on that guidance, Moderna and its investors have sunk more than $750 million into developing and testing its flu vaccine. It did everything it was required to do under law, and the FDA won’t even take a look at its drug. What kind of signal does that send to other drugmakers considering whether to spend gobs of money on developing and testing a new medicine?
Even when the FDA ultimately rejects a drug over safety or efficacy concerns, it usually has the courtesy to review the thing in good faith. Not when it comes to mRNA, apparently. From the Washington Post:
Moderna said the FDA notified the company of its decision on Feb. 3 in a “refusal to file” letter stating that the company’s application was, “on its face, inadequate for review.”
Refuse-to-file letters are infrequently used by U.S. regulators, according to a study published in JAMA Internal Medicine. Over a decade, that study found, only 4 percent of nearly 2,500 applications received such letters.
We keep hearing about President Trump’s supposedly deregulatory economic agenda. Yet in pharmaceutical medicine — one of America’s most successful and innovative industries — federal regulators are running rampant, substituting their own arbitrary will for proper procedure and crushing the prospects of companies they do not like. Lina Khan is probably blushing somewhere at how brazenly Trump’s FDA is throwing its weight around against disfavored enterprises.
The cost of the FDA’s obstruction is not primarily economic. It will be measured in the number of Americans who suffer from diseases that could have been prevented or treated by medicines that were never approved, or even developed. We can start adding it up now: If Moderna’s vaccine is really as good as its Phase 3 trial suggests, millions more Americans may get sick with the flu after receiving less-effective shots than if the FDA had given Moderna a fair assessment. Some of those Americans will die. That is what inevitably happens when the government restricts people from accessing safe and effective medical innovations.
But we’re making America healthy again, don’t you know?