Exhibit 022 · Regulatory action
Moderna mRNA influenza vaccine: advisory committee review and relative efficacy
A prospective influenza vaccine passed an FDA advisory committee meeting last month with a Prescription Drug User Fee Act goal date of August 5, 2026, after the committee initially refused to review the vaccine application in early February.
AJMC reported that a prospective influenza vaccine passed an FDA advisory committee meeting with a Prescription Drug User Fee Act goal date of 5 August 2026, after the committee initially refused to review the application in early February. In a randomized trial of 40,703 participants, Moderna's mRNA influenza vaccine had 26.6 percent relative efficacy (95% CI 16.7–35.4) against a licensed standard-dose influenza vaccine. The comparator was a licensed vaccine.
- Source
- U.S. Food and Drug Administration; VRBPAC; reported by AJMC and CIDRAP
- Date
- February 2026
- Quoted from
- AJMC article, first paragraph
- Grade
- Reported
- Document
- https://www.ajmc.com/view/fda-advisory-committee-supports-moderna-mrna-flu-vaccine-review
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit