FDA AdCom Votes Unanimously in Support of mRNA Flu Vax - Aug 5th PDUFA

研报英文原文证据摘录

FDA AdCom Votes Unanimously in Support of mRNA Flu Vax - Aug 5th PDUFA

s risks for the prevention

of seasonal flu in ages 50-64 years. (a) Panelists generally viewed mFLUSIVA's rVE efficacy in

Study P304 as clinically meaningful and effective vs SD comparator in this population. Discussion

also focused on the vaccine's ability to better induce memory T cell responses vs existing influenza

vaccines, which are often limited by waning immunity, with durable protection seen as a key

potential advantage. (b) Panelists also considered the safety profile to be sufficiently characterized,

with AEs broadly consistent with those observed across Moderna’s established mRNA platform.

The reactogenicity profile and all-cause mortality AEs (while elevated vs comparators) were viewed

as "manageable" within the context of robust post-approval pharmacovigilance. Additionally, one

panelist emphasized the need to assess the durability of rare adverse events, particularly in older,

frail, and immunocompromised populations.

(2) Panelists vote 9 (Yes) / 0 (No) that mFLUSIVA's benefits outweigh its risks for the prevention

of seasonal flu in ages >65. (a) The Committee's discussions were centered around the clinical

meaningfulness of mFlusiva's 27.4% relative vaccine efficacy (rVE) vs standard-dose Fluarix

comparator in this older population, given ACIP preferentially recommends high-dose/adjuvanted

vaccines (standard of care). (b) Absent H2H data showcasing mFLUSIVA's magnitude of benefit Andrew Tsai * | Equity Analyst

relative to the standard of care vaccine, the key topic discussed was whether P303 Part C +1 (415) 229-1566 | atsai@jefferies.com

immunogenicity data comparing mFLUSIVA's (trivalent TIV) vs high-dose Fluzone (quadrivalent Brian Balchin, ACA * | Equity Analyst