MRNA: FDA Advisory Panel Votes 9-0 to Support Risk-Benefit Profile for Flu

研报英文原文证据摘录

MRNA: FDA Advisory Panel Votes 9-0 to Support Risk-Benefit Profile for Flu

EQUITY RESEARCH QUICK TAKE

RBC Capital Markets, LLC

Luca Issi, Ph.D. (Analyst)

Lisa Walter, Ph.D. (Analyst)

Shelby Hill, Ph.D. (Senior Associate)

Cassie Yuan, Ph.D. (Senior Associate)

June 18, 2026

Moderna, Inc.

FDA Advisory Panel Votes 9-0 to Support Risk-Benefit Profile for Flu

NASDAQ: MRNA | USD 63.96 | Sector Perform | Price Target USD 38.00

Sentiment: Positive

The news: An FDA advisory committee voted unanimously to support the risk-benefit profile of MRNA's flu vaccine for both adults

aged 50-64 and 65 and older. The path to this point has been anything but linear. Recall, in February 2026, then CBER Director Vinay

Prasad personally signed a refuse-to-file letter arguing that MRNA had not used SNY's Fluzone HD (the higher-dose vaccine used

predominantly in the 65+ population) as the comparator arm, despite MRNA pointing to FDA written communication from April

2024 explicitly accepting a standard-dose comparator. Within a week, however, the FDA reversed course and agreed to review

the application on a priority basis, a back-and-forth that we flagged as fitting the broader “we play tough” followed by “we are

always willing to negotiate” MO we have observed across other policy domains. Since then, leadership at the FDA has continued to

churn: Prasad departed CBER, Commissioner Makary has since resigned, and Tracy Beth Høeg, the acting CDER director has been

let go. PDUFA date is August 5th and while regulatory uncertainty remains, the panel's unanimous vote across both age groups

is a meaningful endorsement.

Our take: Today's unanimous AdCom vote is clearly a positive data point and likely reduces the risk headed into the PDUFA