Moderna Provides Update on BLA Submission for Combination Vaccine Against Influenza and COVID-19

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, its combination flu/COVID vaccine candidate for adults aged 50 and older. The withdrawal comes after consultation with the FDA. The company plans to resubmit the BLA later in 2025 after obtaining vaccine efficacy data from the ongoing Phase 3 trial of mRNA-1010, its investigational seasonal influenza vaccine. Interim data from the mRNA-1010 trial is expected to be available in summer 2025.

Positive

• Planned resubmission of BLA later in 2025 shows continued commitment to the combination vaccine development
• Phase 3 trial interim data for mRNA-1010 expected in summer 2025, maintaining development timeline

Negative

• Voluntary withdrawal of BLA for mRNA-1083 delays potential market entry of the combination vaccine
• Additional efficacy data requirement suggests potential concerns about the current data package

CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the withdrawal of the BLA for mRNA-1083, plans for future resubmission of the mRNa-1083 BLA, and anticipated timing for efficacy data for Moderna's seasonal flu vaccine candidate, mRNA-1010. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Chris Ridley
Global Head of Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

Why did Moderna withdraw the BLA for its flu/COVID combination vaccine (mRNA-1083)?

Moderna withdrew the BLA to await vaccine efficacy data from the ongoing Phase 3 trial of mRNA-1010, its seasonal influenza vaccine candidate. The decision was made after consultation with the FDA.

When will Moderna resubmit the BLA for mRNA-1083?

Moderna plans to resubmit the BLA later in 2025, after receiving interim efficacy data from the mRNA-1010 Phase 3 trial, which is expected in summer 2025.

What age group is Moderna's mRNA-1083 combination vaccine targeting?

The mRNA-1083 combination vaccine is being developed for adults aged 50 years and older.

What is the relationship between Moderna's mRNA-1010 and mRNA-1083 vaccines?

mRNA-1010 is Moderna's investigational seasonal influenza vaccine, while mRNA-1083 is their combination flu/COVID vaccine candidate. The efficacy data from mRNA-1010's Phase 3 trial will support the BLA resubmission for mRNA-1083.