Moderna获得FDA专家组一致认可流感疫苗

2026-06-19 05:00

A US FDA advisory panel unanimously agreed that the benefits of Moderna's (MRNA) mRNA seasonal flu vaccine, mRNA-1010, outweigh the risks in individuals 50-75 years old.
The agency's Vaccines and Related Biological Products Advisory Committee based its decision on data from several studies, including a late-stage trial involving more than 40,000 adults aged 50 and older (Study 304) and another targeting nearly 3,000 adults aged 65 years and above (Study 303 Part C).
The BLA has an FDA action date of August 5.
Moderna faced a major setback in its effort to gain approval of the shot in February when the FDA issued a refusal-to-file letter saying its application lacked an "adequate and well-controlled" trial. However, later that same month, the agency reversed course.

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