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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.
More on Moderna
- Moderna, Inc. (MRNA) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
- Moderna, Inc. (MRNA) Discusses Intismeran mRNA Immunotherapy and Phase II KEYNOTE-942 Oncology Data Transcript
- Moderna, Inc. (MRNA) Discusses Intismeran mRNA Immunotherapy and Phase II KEYNOTE-942 Oncology Data - Slideshow
- Moderna eyes German production sites amid BioNTech plant closures - report
- Moderna hits three-month high after FDA review for flu shot (update)
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