Introduction There are some adverse reactions in a product label that are so serious, and possibly even preventable, that special labeling is required to highlight this warning information: a “BOXED WARNING.” https://www.fda.gov/media/71866/download https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57 This boxed warning information, “critical for a prescriber to consider,” is commonly referred to as a […]
FDA amended EUA for COVID bivalent mRNA technology booster (April 18th) (Pfzier-BioNTech & Moderna for original & BA4/BA5 clades); then CDC’s ACIP advisory group met April 19th, 2023
VRBPAC (Jan 26th 2023); for this ‘simplified’ approach Dr. Wiseman below outlines the FAILURE & risk of the FDA & CDC decisions given no supporting data, omission of VAERS data on stroke signals This article was republished from the author’s Substack. Dr. David Weisman (excellent scholarship) is the lead […]
FDA Approves Bivalent Vaccine for Babies in TWO DAYS
Pfizer Can Get Anything Approved “At the Speed of Science” The warp-speed approvals of anything that Pfizer asks the FDA to approve continue. On December 5, Pfizer asked the FDA to allow bivalent shots for babies six months and up. Today, on December 8, the application was approved. Not counting the day of […]