FDA Staff Weigh In on Potential First mRNA Flu Shot

Moderna builds commercial muscle as new launches loom

Moderna expands its commercial team, as the FDA issues a mostly positive briefing document on its seasonal flu vaccine, due to face an adcomm tomorrow.

Moderna Is Up 94% This Year: Is It Outperforming Other Vaccine Stocks Like Pfizer and Novavax?

The post Moderna Is Up 94% This Year: Is It Outperforming Other Vaccine Stocks Like Pfizer and Novavax? appeared first on 24/7 Wall St.. Moderna (MRNA) jumps 9% today to $57, extending a +94% YTD rally—the best performer in the vaccine cohort, crushing Pfizer (PFE) at +4% and Novavax (NVAX) at +41%. Moderna's leadership restructuring signals operational readiness for three planned vaccine launches in 2027-2028. Moderna stock carries execution…

FDA Staff Weigh In on Potential First mRNA Flu Shot

(MedPage Today) -- Ahead of an advisory committee meeting this week, FDA reviewers raised no serious efficacy or safety concerns about Moderna's mRNA flu vaccine candidate for adults 50 and older, which has the potential to become the first such...

FDA Say Moderna's mRNA Flu Vaccine 'Effective'

Reviewers with the Food and Drug Administration (FDA) announced that Moderna’s flu vaccine made with mRNA technology is “effective.” While reviewers noted that there is “clinical benefit” to the inoculation, the review document explains that “efficacy in immunocompromised individuals and very frail older adults has not been established.” The lack of data for this population was described as “significant” as the group faces the “highest absolute …

Moderna mRNA Flu Vaccine Effective, FDA Reviewers Say

Moderna’s messenger ribonucleic acid (mRNA) influenza vaccine is effective, but uncertainties remain, Food and Drug Administration reviewers said in a document released on June 16. Data from a Phase 3 trial show the mRNA vaccine, known as mRNA-1010, had a “clinical benefit,” the reviewers said in the 92-page document. The trial compared the immunogenicity and clinical results in a group that received Moderna’s vaccine and compared the results to…

FDA staff scrutinizes evidence supporting Moderna’s flu vaccine

Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.