FDA refuses to review Moderna's influenza vaccine

[lostincalifornia]

The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines.

Moderna, revealing the rejection, took the unusual step of releasing the letter it had received from Vinay Prasad, who heads the FDA’s biologics division. It also issued a strongly worded statement from its CEO Stéphane Bancel, who said the decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”

At the heart of the dispute is what existing influenza vaccine Moderna should have used as a control when testing the efficacy of its new shot, which utilizes the same mRNA technology the company used in its Covid-19 vaccine.

In the “refusal-to-file” letter, Prasad wrote that the FDA does not consider the study in the application to be “adequate and well-controlled” — the standard for FDA approval under the law — because “your control arm does not reflect the best-available standard of care in the United States at the time of the study.” He added: “I note that this determination is consistent with FDA’s advice given to you prior to your study.”

https://www.statnews.com/2026/02/10/fda-refuses-review-moderna-flu-vaccine-application/

[Mysterian]

1. What the actual fuck?

[GreenWave]

2. Fred Trump wanted us to die from plagues, etc. Now sonny boy is leading the effort.