Pfizer/Valneva Aim for FDA Approval of mRNA Shot for Lyme Disease
On Mar. 23, 2026, Pfizer, Inc. of New York City, NY and Valneva SE of Saint-Herblain, France announced that they would seek regulatory approval from the U.S. Food and Drug Administration (FDA) for an experimental mRNA (messenger ribonucleic acid) biologic shot against Lyme disease that they have jointly been developing since 2020. The shot, designated […]
Combination mRNA COVID-Influenza Shot Recommended by European Medicines Agency
The European Medicine Agency (EDA) has recommended marketing authorization for Moderna’s mCombriax mRNA (messenger ribonucleic acid) shot. The product, also known as mRNA-1083, is a genetically engineered biologic targeting both influenza and COVID-19. It builds on work Moderna has done on its next-generation mRNA COVID shot known as mNexSpike and mRNA-1010.1 2 3 The recommendation […]
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 […]
CDC Looking to Break Up MMR Vaccine?
On Oct. 6, 2025, the acting director of the U.S. Centers for Disease Control and Prevention (CDC), Jim O’Neill, called on the manufacturers of the live attenuated MMR (measles, mumps, rubella) vaccine to break up the biologic and develop separate shots for the three diseases it targets. “I call on vaccine manufacturers to develop safe […]
FDA Plans for Expedited Licensure Approval of GSK’s Autism Drug
On Sept. 22, 2025, the U.S. Food and Drug Administration (FDA), in collaboration with the British pharmaceutical company GSK plc, announced plans to fast-track licensure of leucovorin calcium tablets. The drug, which GSK calls Wellcovorin, has long been used to treat anemia and counteract the effects of chemotherapy, The FDA will approve it for use […]
Disturbing Secrets about Vaccines
The vaccine area is much more complicated than I knew when I worked at a department of infectious diseases as a young doctor. I didn’t perceive vaccines could be a problem and had taken all the recommended ones. My 2013 book, Deadly Medicines and Organised Crime, hardly mentions vaccines at all because none of the major […]