Moderna Inc: Positive AdCom on flu vax, should derisk PDUFA coming up in August

Research evidence excerpt

Moderna Inc: Positive AdCom on flu vax, should derisk PDUFA coming up in August

ogenicity 12/26E

endpoint compared to Fluzone HD rather than the clinical endpoint of relative vaccine UBS Cons.

efficacy (rVE). As such, the potential accelerated approval stipulates that MRNA will run Q1 (3.40) (3.40)

Q2E (1.85) (2.08)

a post-marketing Phase IV study that measures mFLUSIVA's rVE head-to-head to with

Q3E (1.38) (1.12)

HD, recombinant, or other enhanced vaccines in over ~400k patients across up to two

Q4E (1.89) (1.98)

flu seasons. 12/26E (8.52) (8.68)

12/27E (5.23) (4.75)

Approval here would derisk the COVID combo too which we see having a greater value 12/28E (2.04) (3.12)

proposition and is even already approved in the EU. MRNA's technology is able to mass

Michael Yee

produce the vaccine within 2 months so there is some advantage here for better strain

Analyst

selection - ie in June and closer to the flu and covid season vs. in the winter Feb/March michael.yee@ubs.com

months and too far away from when the strains is actually identified. Although it is +1-305-536 9101

currently unclear how communication around influenza strain selection from FDA will

Dina Elmonshed

adjust to take advantage of this compressed timeframe. The launch is not in MRNA's Analyst

2026 guidance and more of a 2027 growth driver but again a wait and see story as dina.elmonshed@ubs.com

vaccine sales and uptake remains uncertain especially in the US. Overall, investor +1-212-649 8276

dialogue is largely centered on the potential INT Phase III interim readout, which our

Kyle Yang, CFA

deep dive (HERE) suggests could come by late fall (i.e. Oct/Nov) with a 50%+ PoS. Associate Analyst

Norovirus interim is also set to hit this year and we note the trial interestingly only kyle.yang@ubs.com