Moderna’s mNEXSPIKE mRNA COVID-19 Shot Approved by European Commission
The European Commission (EC) has granted marketing authorization for Moderna’s mNEXSPIKE mRNA COVID-19 shot, allowing it to be marketed across the European Union (U.N.). The authorization follows a regulatory review and permits all 27 E.U. Member States, as well as Iceland, Liechtenstein and Norway, to consider the shot for use within their vaccination programs. It […]
FDA Greenlights Review of Moderna’s mRNA Flu Shot After Application Amended
On Feb. 18, 2026, the U.S. Food and Drug Administration (FDA) agreed to review Moderna’s application for its mRNA influenza shot, known as mRNA-1010, after the company amended its submission to address regulatory concerns. The agency accepted the updated biologics license application and set a target action date of Aug. 5, 2026, allowing the shot […]
FDA Refuses to Review Moderna’s mRNA Influenza Shot License Application
The U.S. Food and Drug Administration (FDA) has declined to accept for review Moderna’s Biologics License Application (BLA) for its mRNA-based seasonal influenza shot, citing concerns about the completeness of the submission. The decision highlights the agency’s commitment to maintaining clear evidentiary standards for approving the licensing of new vaccines.1 On Feb. 3, 2026, the […]
Changes in Eye Health Linked to mRNA COVID-19 Shots
A recent prospective study published in 2025 in Ophthalmic Epidemiology has identified measurable changes in the cornea of the eye following receipt of mRNA COVID-19 biological, raising new questions about potential effects on eye health. Researchers observed differences in corneal thickness and endothelial cell characteristics in healthy adults after two doses of Pfizer/BioNTech’s Comirnaty COVID […]
Nursing Home Residents Routinely Given Vaccines Rarely Represented in Clinical Trials
According to researchers at the University of Aberdeen in Scotland, people living in older care homes have been largely excluded from vaccine trials, despite being among the groups most likely to receive vaccines, especially during public health emergencies. Researchers say this mismatch has limited the evidence available on how vaccines perform in care nursing home […]
CDC Changes Recommendations for Six Childhood Vaccines
The U.S. Department of Health and Human Services (DHHS) announced updates to the national childhood vaccine schedule involving six vaccines (rotavirus, COVID-19, influenza, meningococcal disease, hepatitis A, and hepatitis B) following a presidential memorandum directing the U.S. Centers for Disease Control and Prevention (CDC) to review and revise its recommendations. The changes clarify which vaccines […]