Moderna has voluntarily withdrawn its pending Biologics License Application (BLA) for mRNA-1083, a flu/COVID combination vaccine candidate for adults aged 50 years and older. The decision comes after consultation with the US Food and Drug Administration (FDA). Moderna plans to resubmit the BLA later this year, once data from its ongoing Phase 3 trial of mRNA-1010, an investigational seasonal influenza vaccine, is available.
The company expects interim results from the mRNA-1010 trial to be released this summer. Moderna continues to advance its mRNA platform, which has enabled the development of therapeutics and vaccines for various diseases.
Moderna’s mRNA technology allows for rapid development and delivery of medicines, transforming how diseases are treated and prevented. The company is committed to responsibly changing the future of human health through its work in mRNA medicine.
Source: https://investors.modernatx.com/news/news-details/2025/Moderna-Provides-Update-on-BLA-Submission-for-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx