RFK Jr.-Led FDA Rejects Moderna's mRNA Flu Vaccine After Suddenly Announcing Standards Never Required Before

The best thing Donald Trump did in his first term was his rapid approval and support for mRNA vaccines against Covid. But the populists and conspiracy theorists who brought him to power turned against vaccines, and especially against mRNA technology. So Trump installed anti-vaccine crackpot RFK Jr. as Secretary of Health and Human Services, who is now abusing his power to block new vaccines.

The medical news site Healio reports:

The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.

In a press release, Moderna noted that the FDA’s rejection of the vaccine, mRNA-1010, did not come with any safety or efficacy concerns. Instead, in a letter to the company, the FDA said the application lacked an “adequate and well-controlled” study. …

Moderna said Prasad’s letter is “inconsistent with previous written communications from CBER [Center for Biologics Evaluation and Research] to Moderna” in 2024, when Moderna submitted its phase 3 study protocol for review, as well as in 2025 upon completion of the phase 3 trial.

Specifically, CBER told the company in 2024 that “it would be acceptable to use a licensed standard dose influenza vaccine as the comparator,” according to Moderna. …

In 2025, CBER requested supportive analyses on the comparator—which were provided by Moderna—be included with submission and indicated that the data would be significant during the biologics license application review. According to Moderna, at no point did CBER indicate there would be a refusal to review the application because of the comparator. …

“The arbitrary and unpredictable nature of the FDA’s decision—after Moderna had already consulted with them regarding the trial’s characteristics—is of major concern,” Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, told Healio. “Companies need predictability if they are going to invest a billion dollars to develop a new product. If the regulatory pathway is subject to arbitrary changes, they will no longer be willing to make such investments.”

This is a microcosm of how Trump’s abuses of power are crippling the economy, because no one can plan when the rules about vaccines, tariffs, and everything else are constantly changing, depending on the interests or personal obsessions of the people in power.

The Executive Watch is a project of the Institute for the Study of Modern Authoritarianism, and its flagship publication The UnPopulist, to track in an ongoing way the abuses of the power of the American presidency. It sorts these abuses into five categories: Personal Grift, Political Corruption, Presidential Retribution, Power Consolidation, and Policy Illegality. Click the category of interest to get an overview of all the abuses under it.

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