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 “black box.” (https://www.fda.gov/media/71866/download) Boxed Warnings […]
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 Older,” has a status of […]