Core Viewpoint - Moderna's development of seasonal vaccines is considered 'risky' due to the FDA's refusal to review its mRNA-based flu vaccine application, reflecting a conflict between the company's mRNA-centric approach and the U.S. government's changing stance on mRNA technology [1] Group 1: Company Challenges - Moderna faces increasing pressure to expand its business as COVID-19 vaccine sales decline [1] - The FDA's decision not to review the flu vaccine application is a significant setback for Moderna's mRNA development efforts [1] - The company has described the FDA's communication as "inconsistent," indicating potential challenges in regulatory interactions [1] Group 2: Industry Context - The situation highlights the broader risks associated with mRNA technology in the current regulatory environment [1] - Analysts suggest that the shifting views of the U.S. government on mRNA technology pose risks for companies like Moderna that are heavily invested in this area [1]
Moderna's work developing seasonal vaccines is ‘risky' under current FDA, analyst says