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U.S. Approves First mRNA Flu Vaccine, Signaling Potential Shift in Vaccine Production

U.S. Approves First mRNA Flu Vaccine, Signaling Potential Shift in Vaccine Production

The FDA has approved Moderna's mFlusiva, the first mRNA flu vaccine in the U.S., for adults aged 50 and older. This vaccine uses mRNA technology to provide genetic instructions for the body to produce a harmless piece of the virus, potentially allowing for faster and more accurate responses to evolving flu strains. In trials, mFlusiva outperformed a standard-dose flu vaccine, offering a promising alternative to traditional flu vaccines that rely on virus grown in chicken eggs.

FDA Approves Moderna's mRNA-Based Flu Vaccine for Adults Over 50

FDA Approves Moderna's mRNA-Based Flu Vaccine for Adults Over 50

The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based seasonal influenza vaccine, mFLUSIVA, for adults aged 50 and older. This marks the first flu shot utilizing the same mRNA technology as Moderna's COVID-19 vaccine to be approved in the U.S. The approval, granted on August 5, is aimed at older populations who are more vulnerable to severe flu complications. Clinical trials demonstrated that mFLUSIVA outperformed standard-dose flu vaccines, showing a 26.6% higher efficacy. However, its use in adults aged 65 and older remains under 'accelerated approval,' pending further confirmatory studies.

FDA Approves Moderna's mRNA-Based Flu Vaccine Amid Funding Cuts

FDA Approves Moderna's mRNA-Based Flu Vaccine Amid Funding Cuts

The FDA has approved Moderna's mRNA-based flu vaccine for adults aged 50 and older, marking a significant milestone as it is the first time mRNA technology, previously used in COVID-19 vaccines, has been approved for seasonal flu prevention. This approval comes at a time when federal funding for mRNA vaccine research has been significantly reduced, raising concerns about the future of mRNA technology development. Smaller companies and universities, which rely heavily on government funding for clinical trials, may face challenges in advancing new vaccines due to these cuts. Despite the funding issues, Moderna has managed to fund its research independently, allowing the flu vaccine to be available within weeks.

FDA Approves Moderna's mFLUSIVA, Strengthening Its Position in mRNA Vaccine Market

FDA Approves Moderna's mFLUSIVA, Strengthening Its Position in mRNA Vaccine Market

FDA Approves Moderna's mFLUSIVA, Strengthening Its Position in mRNA Vaccine Market

Trump officials propose new requirements for food additives and ingredients

Trump officials propose new requirements for food additives and ingredients

U.S. health officials want food manufacturers to provide more information about new additives and ingredients

The Latest: Trump calls for spacing out childhood shots, against medical groups’ guidance

The Latest: Trump calls for spacing out childhood shots, against medical groups’ guidance

President Donald Trump has signed an executive order calling for revamped childhood vaccine recommendations that promote his long-held belief that certain shots should be spaced out into separate medical visits

Major Retailers Issue Recalls Due to Salmonella Outbreak Linked to Jalapeños

Major Retailers Issue Recalls Due to Salmonella Outbreak Linked to Jalapeños

A Salmonella outbreak has prompted several major U.S. grocery chains, including Target, Walmart, and Whole Foods, to issue recalls. The outbreak, which has sickened hundreds, has been traced back to jalapeño peppers distributed by Coast Citrus Distributors and grown in Sinaloa, Mexico. The Food and Drug Administration (FDA) reported that Taylor Fresh Foods issued a voluntary recall on its finished products containing the affected jalapeños. The outbreak has resulted in over 300 cases of Salmonella across 27 states, with Colorado and Minnesota reporting the highest numbers. The FDA and the U.S. Department of Agriculture (USDA) have released lists of affected products, urging consumers to dispose of them and seek refunds.

FDA Faces Challenges in Meeting Foreign Food Safety Inspection Mandates Amid Staffing and Budget Constraints

FDA Faces Challenges in Meeting Foreign Food Safety Inspection Mandates Amid Staffing and Budget Constraints

The Food and Drug Administration (FDA) is struggling to meet its congressional mandate for foreign food safety inspections, conducting fewer than 1,000 inspections in 2025, far below the required number. The FDA's mandate, established to prevent contaminated food from entering the U.S., requires nearly 20 times the inspections currently being conducted. The agency cites budgetary and staffing constraints as significant barriers, with the number of inspectors not keeping pace with losses. The FDA has not requested a revision of the mandate from Congress, despite deeming it unrealistic. The agency's budget has not increased to match inflation, and recent government layoffs have further strained resources. The FDA's inspection rate has declined, with foreign inspections dropping by 29% from 2024. The agency is working to expand staffing at foreign posts, but challenges remain.

Major Grocery Chains Recall Products Amid Salmonella Outbreak Linked to Jalapeños

Major Grocery Chains Recall Products Amid Salmonella Outbreak Linked to Jalapeños

Several major grocery chains, including Target, Walmart, and Whole Foods, have issued recalls due to a Salmonella outbreak linked to jalapeño peppers. The outbreak has resulted in hundreds of illnesses across 27 states. The Food and Drug Administration (FDA) reported that the outbreak is connected to fresh jalapeños grown in Sinaloa, Mexico, and distributed by Coast Citrus Distributors. Taylor Fresh Foods initiated a voluntary recall of its products containing the affected jalapeños. Other retailers involved in the recall include Hannaford, Kroger, and Trader Joe’s. The recalled products have 'Best If Used By' dates up to August 16, 2026, and were distributed to retail centers in multiple states. Consumers are advised to dispose of the recalled products and can seek refunds at the point of purchase.

BARDA Announces Major Contract for Pandemic Influenza Vaccine Preparedness

BARDA Announces Major Contract for Pandemic Influenza Vaccine Preparedness

The Biomedical Advanced Research and Development Authority (BARDA) has issued a pre-solicitation notice for a significant long-term contract aimed at sustaining and expanding the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. This initiative includes the U.S. National Pre-pandemic Influenza Vaccine Stockpile (NPIVS). The notice, posted on July 30, 2026, signals BARDA's intent to establish multi-year partnerships with licensed influenza manufacturers to ensure pandemic influenza vaccines and adjuvants are ready for rapid deployment. The contract aims to maintain regulatory and manufacturing readiness during non-pandemic periods, allowing for swift response to emerging strains.

Nanotechnology Advances COVID-19 Vaccine Delivery with Lipid Nanoparticles

Nanotechnology Advances COVID-19 Vaccine Delivery with Lipid Nanoparticles

The COVID-19 pandemic has accelerated the development of vaccines, with nanotechnology playing a crucial role in enhancing vaccine delivery systems. Lipid nanoparticles (LNPs) have been instrumental in addressing challenges associated with traditional vaccine approaches, such as immunogenicity and stability. These nanoparticles have become the backbone of mRNA vaccines like Pfizer-BioNTech and Moderna, improving vaccine stability, enabling precise cellular delivery, and reducing side effects. The chapter discusses the transformative role of nanotechnology in vaccine delivery, focusing on mRNA, self-amplifying RNA (saRNA), and circular RNA (circRNA) vaccines. Innovations in thermostable formulations, mucosal delivery systems, and AI-driven vaccine design are paving the way for more accessible and effective immunization strategies.

FDA and USDA Issue Alerts on Food Products Due to Listeria and Salmonella Risks

FDA and USDA Issue Alerts on Food Products Due to Listeria and Salmonella Risks

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) have issued several alerts and recalls concerning food products due to potential contamination risks. Notably, City Foods, Inc. is recalling approximately 3,215 pounds of ready-to-eat pastrami and corned beef products due to possible Listeria contamination. Additionally, the FSIS has issued a public health alert for meat and poultry products containing FDA-regulated jalapeños that have been recalled due to possible Salmonella contamination. These actions are part of ongoing efforts to ensure food safety and protect public health.