Replies to post #13231 on Moderna Inc (MRNA)

[Vexari]

Take a step back and listen to oneself

What does it actually mean

From a different

Perspective

[axelvento]

"I read this" The PDUFA (Prescription Drug User Fee Act) action date for mRNA-1345 is May 12, 2024, by which time the Company expects the U.S. FDA's response to its Biologics License Application (BLA). If the outcome is positive, the Company anticipates that the U.S. CDC Advisory Committee on Immunization Practices (ACIP) will include mRNA-1345 on the agenda of its June 26-28 meeting. Assuming that corresponding marketing authorizations would be granted as expected, the Company also plans to launch its RSV vaccine in Australia and Germany in 2024 and other markets in 2025 due to regulatory and tender timing.

[DewDiligence]

FDA delays action date on MRNA’s RSV vaccine:

https://finance.yahoo.com/news/moderna-announces-investigational-rsv-vaccine-110000123.html

Moderna…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.

This delay looks like a non-issue as long as FDA approval comes before the ACIP meeting in June. See #msg-173915224 for related info.

[DewDiligence]

MRNA—FDA approves mResvia RSV vaccine_for_adults 60+:

https://www.accesswire.com/870069/moderna-receives-us-fda-approval-for-rsv-vaccine-mresvia

This is the third approved RSV vaccine for the US adult market, the other two being GSK’s Arexvy (#msg-171831470) and PFE’s Abrysvo (#msg-172028729), both of which were approved in May 2023 and are indicated for adults 60+. (PFE’s Abrysvo is separately approved for maternal use to provide short-term protection for newborns.)

MRNA’s mResvia is the only RSV vaccine that comes in a prefilled syringe, but its efficacy appears to be somewhat less than Arexvy and Abrysvo based on cross-trial comparisons.

Commercial uptake of mResvia will depend to a large degree on the recommendations from CDC’s ACIP* regarding the patient population to be treated and the re-dosing schedule of each of the vaccines. If ACIP recommends biennial boosting with Arexvy and Abrysvo and annual boosting with MRNA’s mResvia, that would be a pretty big blow to mResvia’s commercial prospects, IMO. I’m not saying such an outcome is likely, but it is possible.

ACIP’s recommendations generally dictate reimbursement policy in the US market. ACIP’s meeting is Jun 26-27.

*Advisory Committee on Immunization Practices.