Feb. 20 (UPI) -- Regulatory predictability is crucial for vaccine makers as they plan trials for future products but shakeups in the United States' top health agencies are making the process more difficult to navigate.
The U.S. Food and Drug Administration issued a refuse-to-file notice to drugmaker Moderna for its mRNA-1010 influenza vaccine earlier this month. The agency has since changed course, agreeing to review the vaccine, but the initial decision is just the latest signal to the industry that the U.S. market for vaccines has become less receptive.
In a statement to UPI, the FDA said it rejected Moderna's application "because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy."
"Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists," spokesman Andrew Nixon said in a statement. "The most protective flu shots for seniors are a subset of high dose flu shots recommended by the CDC Advisory Committee on Immunization Practices, which would have served as the proper control in this study."
