Moderna provides an update on BLA submission for the influenza vaccine combination and covid-19
Cambridge, MA / Access Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq: RNA), announced today that in consultation with the Food and Drug Administration of the United States (FDA), the company voluntarily withdrawn the demand for pending organic license (Bla) for the mRNA-1083, its flu / combination of vaccine against adult vaccine for adults of 50 and over. The Company plans to submit the Blae later this year, after the effectiveness data of the vaccines of phase 3 trial during its influenced vaccine of flu and investigation, mRNM-1010, are available. Moderna continues to expect the temporary data of the ARNM-1010 trial to be available this summer.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Thanks to the advancement of mRNA technology, Moderna reinvents the way drugs are manufactured and transform the way we deal with and prevent diseases for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed drugs at an unprecedented speed and efficiency, including one of the oldest and most effective vaccines COVID-19.
Moderna’s mRNA platform has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team motivated by modern values and mentalities to change the future of human health in a responsible way, Moderna strives to offer people as much impact as possible through mRNA medicines. For more information on Moderna, please visit Modernenatx.com and connect with us to X (formerly Twitter), Facebook, Instagram, YouTube and Linkedin.
Prospective declarations
This press release contains prospective declarations within the meaning of the 1995 law of the reform of the private security dispute, as modified, including the declarations concerning: the withdrawal of the blanm-1083, the plans for the future submission of the mRA-1083 bla and the anticipated timing for the effective data for the candidate of the Vaccination against the Moderna Fluing of Moderna, MRNA-1010. The prospective declarations of this press release are neither promises nor guarantees, and you should not grant undue dependence to these prospective declarations because they imply risks, uncertainties and other known and unknown factors, many of which are outside the will of Moderna and which could ensure that the real results differ materially from those expressed or involved by these heavy states of modern. These risks, uncertainties and other factors include, among other things, these risks and uncertainties described in the context of the “Risk factors” of the section in the Moderna annual report on form 10-K for the year ended December 31, 2024, and in the subsequent deposits made by Moderna with the Securities and Exchange American Commission, which are available on the website of the dry to www.sec.gov. Unless the law required, Moderna declines any intention or responsibility to update or revise the prospective declarations contained in this press release in the event of new information, future developments or otherwise. These prospective declarations are based on Moderna’s current expectations and only speak on the date of this press release.
Modern contacts
Media:
Chris Ridley
World Head of Media Relations
+1 617-800-3651
Chris.ridley@modernatx.com
Investors:
Lavine Talukdar
Senior vice-president and head of investors relations
+1 617-209-5834
Lavina.talukdar@modernatx.com
SOURCE: Moderna, Inc.
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