Moderna Announces Update on Investigational RSV Vaccine
Moderna, Inc. (NASDAQ: MRNA) receives an update from the U.S. FDA regarding the review of its investigational RSV vaccine, mRNA-1345. The FDA will not complete the review by the PDUFA date of May 12, 2024, due to administrative constraints but expects to finish it by the end of May 2024. Moderna remains optimistic about the review and is on track for a CDC Advisory Committee meeting in June 2024.
The FDA has not raised any safety, efficacy, or quality concerns related to Moderna's investigational RSV vaccine, mRNA-1345.
Moderna is appreciative of the FDA's commitment and is looking forward to assisting in the review process and the upcoming ACIP meeting in June 2024.
The FDA will not complete the review of mRNA-1345 by the PDUFA date of May 12, 2024, leading to a delay in the approval process due to administrative constraints.
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Agency has indicated it expects to complete the review by end of May
CAMBRIDGE, MA / ACCESSWIRE / May 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345, Moderna's investigational respiratory syncytial virus (RSV) vaccine, by the previously communicated Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.
The FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345.
Moderna remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) June 26-27, 2024, meeting, which is necessary prior to commercial launch.
"Moderna is very grateful to the FDA for their continued efforts and diligence," said Stephen Hoge, M.D., President of Moderna. "We look forward to helping the agency complete the review of our application, and to the June ACIP meeting."
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 potential approval of the BLA for mRNA-1345 by the FDA, the timing for that approval, and the Company's expectations regarding the review of mRNA-1345 at the June ACIP meeting. 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, 2023 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
Christopher.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 accesswire.com
FAQ
Why will the FDA not complete the review of mRNA-1345 by the PDUFA date?
The FDA cited administrative constraints as the reason for not completing the review by the PDUFA date of May 12, 2024.
What is the new expected timeline for the FDA review of mRNA-1345?
The FDA anticipates completing the review by the end of May 2024.
Is there any safety concern raised by the FDA regarding mRNA-1345?
No, the FDA has not raised any safety, efficacy, or quality concerns related to Moderna's investigational RSV vaccine, mRNA-1345.
When is Moderna's mRNA-1345 expected to be reviewed at the CDC's ACIP meeting?
Moderna's mRNA-1345 is scheduled to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) meeting on June 26-27, 2024.
