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 […]
Carol Taccetta, MD, Requests References from CBER Director to Support CDC’s “[Building] Evidence” That Experimental Bivalent COVID-19 Vaccines Are “Safe and Effective” During Pregnancy and “Not Associated with Fertility Problems”
Introduction The CDC recommends “COVID-19 vaccination” to “people who are pregnant, breastfeeding, trying to get pregnant now, or those who might become pregnant in the future.” (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html) Pfizer/BioNTech’s study, “To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and […]
A Drug Safety Physician’s Correspondence with the FDA: A Quest for Accuracy in Investigational Bivalent mRNA COVID-19 ‘Vaccine’ Adverse Event Reporting
Introduction On November 4, 2022, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) concluded that, based on Vaccine Adverse Events Reporting System (VAERS) and v-safe data received between August 31, 2022, and October 23, 2022, “Health care providers and patients can be […]