Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.

The Informed Consent Action Network (ICAN) opposes the licensure of Moderna's mRNA influenza vaccine, Mflusiva, citing an unfavorable benefit-risk ratio, concerning safety signals (including cardiac and hematologic risks), and a lack of clinically meaningful evidence of efficacy compared to current standards of care for older adults. They urge the committee to require additional clinical investigation before granting licensure.

The commenter opposes the approval of Moderna's mRNA flu vaccine (MFLUSIVA), arguing that its higher reactogenicity and modest efficacy gains do not outweigh its benefits compared to protein-based alternatives like Novavax. They express concern over regulatory consistency and urge the FDA to prioritize vaccines with stronger evidence of benefit-risk balance for older adults.

An individual is strongly opposing the approval of the mRNA influenza vaccine, arguing that the mRNA platform is dangerous, lethal, and should be banned for all uses. The commenter claims that mRNA technology is a bioweapon and cites various sources to allege that previous mRNA vaccines were unsafe and ineffective.

A registered nurse and participant in the Moderna mRNA flu vaccine phase 3 trial supports the approval of the vaccine. The commenter emphasizes the need for more flu vaccine options and praises the quality of the trial.

Marcia Cohen Zakai, a senior citizen, supports the approval of Moderna's mRNA influenza vaccine. She argues that the vaccine's ability to better match flu strains and improve effectiveness will increase public uptake and protect the community.

The commenter supports the development and use of mRNA influenza vaccines, specifically highlighting Moderna's mRNA-1010. They argue that mRNA technology allows for faster production and better antigenic matches, which are crucial for protecting high-risk populations like older adults.

An individual is writing on behalf of their family to express strong support for the approval of the MFLUSIVA mRNA influenza vaccine. They argue that the vaccine is a necessary advancement in flu protection and emphasize the importance of individual choice and scientific expertise in the approval process.

A healthcare professional at a Midwestern university supports the review of the mRNA influenza vaccine, emphasizing the need for improved options for older and immunocompromised adults. The commenter stresses the importance of scientific rigor and data-driven decision-making in the approval process.

A retired physician supports the approval of Moderna's mRNA influenza vaccine. They argue that the mRNA platform allows for faster development and better matching of circulating strains compared to current vaccines.