FDA Prescription Drug User Fee Act (PDUFA) goal date remains August 5, 2026

CAMBRIDGE, MA / ACCESS Newswire / June 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, Moderna's investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and voted 9-0 that the benefits of mRNA-1010 outweigh its risks for the prevention of influenza disease in adults 65 years of age and older.

"We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," said Stéphane Bancel, Chief Executive Officer of Moderna. "Influenza continues to cause substantial illness and hospitalizations among older adults each year. We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review."

According to the U.S. Centers for Disease Control and Prevention (CDC), seasonal influenza remains a significant public health burden.[1] Older adults account for a disproportionate share of severe influenza outcomes, including hospitalizations and deaths.

The VRBPAC discussion included data from Moderna's Phase 3 clinical program, including the primary analysis results from the pivotal Phase 3 clinical trial (NCT06602024), previously announced in June 2025 and recently published in The New England Journal of Medicine. These data further support the potential of mRNA-1010 to provide a differentiated non-egg-based option for influenza prevention in older adults.

The safety profile of mRNA-1010 observed in the Phase 3 program was consistent with previously reported studies of Moderna's influenza vaccine candidate.

The FDA will consider the recommendations of VRBPAC as part of its ongoing review of Moderna's Biologics License Application (BLA) for mRNA-1010. Advisory committee recommendations are non-binding, and the FDA is responsible for making the final approval decision.

mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada and Australia. Moderna has received a U.S. FDA Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Regulatory submissions in additional countries are planned during 2026.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is 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, 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 benefit-risk profile of mRNA-1010; the FDA's ongoing review of the BLA for mRNA-1010 and the FDA's final approval decision; the PDUFA goal date; mRNA-1010's safety profile; ongoing regulatory reviews of mRNA-1010 in additional countries; and additional planned regulatory submissions for mRNA-1010. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, 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.

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Moderna Contacts

Media:
Chris Ridley
Vice President, Global Head of Communications
+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

[1] https://www.cdc.gov/flu/whats-new/2025-2026-influenza-activity.html

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

Moderna Announces FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010, an Investigational Seasonal Influenza Vaccine