The FDA has delayed its decision on Moderna’s investigational respiratory syncytial virus (RSV) vaccine due to administrative constraints, the biotechnology company announced in a release.1 The federal agency said that it expects to complete a review of the Biologics License Application (BLA) for mRNA-1345 by the end of May, instead of the original Prescription Drug User Fee Act (PDUFA) date of May 12.
Moderna said that the FDA did not inform it “of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345.” The vaccine is still set to be reviewed at a meeting with the CDC’s Advisory Committee on Immunization Practices (ACIP) that is being held June 26 to 27.
Key Takeaways
- The FDA has postponed its decision on Moderna's investigational RSV vaccine, mRNA-1345, citing administrative constraints. The review is now expected to be completed by the end of May.
- Despite the delay, the FDA has not raised any concerns regarding the safety, efficacy, or quality of mRNA-1345. Moderna remains confident in the vaccine's potential and looks forward to assisting the FDA in completing the review process.
- mRNA-1345's rolling BLA submission was supported by data from the ConquerRSV study, demonstrating significant efficacy in preventing RSV-associated lower respiratory tract disease.
"Moderna is very grateful to the FDA for their continued efforts and diligence," Stephen Hoge, MD, president of Moderna, said in a release.1 "We look forward to helping the agency complete the review of our application, and to the June ACIP meeting."
In August 2021, mRNA-1345 received fast track designation from the FDA, which helps facilitate the development and expedite the review of therapies for serious conditions that fill an unmet need. Moderna subsequently initiated the rolling submission process for a BLA for the vaccine in July 2023.3
READ MORE: The Respiratory Disease Trifecta: What to Know About COVID-19, Flu, and RSV
The rolling BLA submission was supported by data from the ConquerRSV study (NCT05127434), a phase 2-3 trial evaluating the safety and tolerability of mRNA-1345, as well as the efficacy of a single dose to prevent a first episode of RSV-associated lower respiratory tract disease. Findings from the study were published in the New England Journal of Medicine in December 2023.4
ConquerRSV included 35541 participants aged 60 years of older who received either 1 dose of mRNA-1345 or placebo. Primary efficacy end points included prevention of RSV-associated lower respiratory tract disease with at least 2 signs or symptoms and with at least 3 signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease.
Findings from the study showed that, over a median follow up of 112 days, the vaccine had an efficacy of 83.7% against RSV-associated lower respiratory tract disease with at least 2 signs or symptoms and 82.4% with at least 3 signs or symptoms. Against RSV-associated acute respiratory disease, the vaccine had an efficacy of 68.4%. The vaccine also protected against both A and B subtypes of RSV.
Additionally, most adverse reactions to the vaccine were mild to moderate in severity and only lasted for a short time. Serious adverse events occurred in 2.8% of participants in each group.
"Our mRNA platform has allowed us to move from initial clinical testing to our first international phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just 2 years, enabling us to tackle this pervasive public health burden with speed and clinical rigor,” Stéphane Bancel, CEO of Moderna, said in a release at the time the BLA was submitted.3 “mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future—further demonstrating the tremendous potential of mRNA to combat disease."
READ MORE: Immunization Resource Center
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References
4. Wilson E, Goswami J, Baqui AH, et al. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023;389(24):2233-2244. doi:10.1056/NEJMoa2307079
