Moderna Withdraws BLA for Flu/COVID Combination Vaccine, Plans Resubmission Following Phase 3 Trial Results
Moderna Inc. has announced the voluntary withdrawal of its Biologics License Application $(BLA.AU)$ for its combination vaccine against influenza and COVID-19, mRNA-1083, in consultation with the U.S. Food and Drug Administration (FDA). The company plans to resubmit the application later this year, once efficacy data from the ongoing Phase 3 trial of its seasonal influenza vaccine, mRNA-1010, become available. This decision reflects an ongoing regulatory review process, with interim data expected this summer. No grant or funding information was specified in the announcement.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moderna Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1030190) on May 21, 2025, and is solely responsible for the information contained therein.
免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。