Moderna Inc. (MRNA)

Research evidence excerpt

Moderna Inc. (MRNA)

Goldman Sachs Moderna Inc. (MRNA)

background, in August 2025, following completion of the Ph3 efficacy study, MRNA held

a pre-submission meeting with CBER. In written feedback, CBER requested that

supportive analyses on the comparator be included in the submission - MRNA then

provided the additional analyses requested by CBER in its submission, including data

from a separate Ph3 study (P303 Part C) comparing mRNA-1010 against a licensed

high-dose influenza vaccine.

The VRBPAC will vote on the following questions:

1. Do the benefits of mFlusiva outweigh its risks for the prevention of influenza disease

in adults 50 through 64 years of age? (X Yes, X No, X Abstain).

2. Do the benefits of mFlusiva outweigh its risks for the prevention of influenza disease

in adults 65 years of age and older? (X Yes, X No, X Abstain).

Below, we summarize key points discussed in the briefing documents.

On clinical efficacy, the primary basis for traditional approval in ages 50-64,

mFlusiva demonstrated superior efficacy over the standard-dose influenza vaccine.

In the pivotal P304 Ph3 Study (n=40,805), mFlusiva demonstrated a relative vaccine

efficacy (rVE) of 26.6% (95% CI: 16.7, 35.4) against RT-PCR–confirmed influenza-like

illness compared with a licensed standard-dose comparator in adults ≥50 years of age.

The vaccine met all prespecified success criteria for noninferiority, superiority, and

super-superiority. Notably, rVE against higher-level healthcare outcomes

(hospitalization, ER, or urgent care visits) was 47.9% (95% CI: 12.8, 68.9), supporting

clinical meaningfulness. Point estimates of rVE were consistent across age subgroups

(25.3%–28.0%) and influenza strain types (22.2%–29.6%).

mFlusiva showed superior immunogenicity versus Fluzone high-dose in adults 65