FDA to Review Moderna mRNA Flu Vaccine Safety Data
Published Date: 5/22/2026
Notice
Summary
The FDA is holding a public meeting on June 18, 2026, to talk about the safety and effectiveness of MFLUSIVA, a new flu vaccine made by Moderna. Anyone can watch online and share their thoughts before June 17. This is a big deal for people who get flu shots and could affect how this vaccine is used and approved.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Advisory Review of Moderna mRNA Flu Vaccine
If you are 50 years of age or older, FDA's advisory committee will meet on June 18, 2026 to discuss the safety and effectiveness of MFLUSIVA (an mRNA influenza vaccine manufactured by Moderna) for preventing influenza A and B. The public docket for comments (Docket No. FDA-2026-N-4162) closes June 17, 2026, and comments received by June 12, 2026 will be provided to the Committee.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
Previous / Next Documents
Previous: 2026-10320, Caribbean Fishery Management Council's Outreach and Education Advisory Panel; Public Hybrid Meeting
The Caribbean Fishery Management Council’s Outreach and Education Advisory Panel is hosting a hybrid public meeting on June 24, 2026, to discuss fishery education and outreach plans affecting local fishing communities and stakeholders. This meeting offers a chance to join in person or online, making it easier for everyone to get involved and stay informed about upcoming changes and initiatives. No direct costs or new rules are announced yet, but it’s a key step in shaping future fishery programs.
Next: 2026-10322, Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits
The government is reviewing a special fishing permit request that would let certain boats fish in areas usually off-limits to protect habitats. This permit supports a project by the Coonamessett Farm Foundation to use clam dredges in the Great South Channel Habitat Management Area. People have until June 8, 2026, to share their thoughts, and this could change how some fishing rules apply, but no new fees are mentioned.