Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study
Pfizer, Inc. has withdrawn its emergency use authorization (EUA) application for its experimental BNT162b2 (also known as “Comirnaty”) messenger RNA (mRNA) COVID-19 biologic (developed in collaboration with Germany’s BioNTech) in India.1 Pfizer was the first pharmaceutical company to apply for an EUA to distribute a COVID biologic in India in 2021. However, India’s regulatory agency […]
College Student in New York Dies of Myocarditis Related to Pfizer COVID Shot
A 24-year-old student at Corning Community College in Corning, New York died on Oct. 27, 2021, about six weeks after receiving the second dose of Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) biologic for COVID-19. George Watts Jr., who was healthy and had no underlying medical conditions, was vaccinated in August and […]
Pfizer, BioNTech Seek COVID Biologic Emergency Use Authorization for Infants as Young as Six Months Old
Pfizer and BioNTech have requested emergency use authorization (EUA) for doctors to administer two doses of their mRNA COVID-19 biologic to infants as young as six months old. A statement from Pfizer states that the “rolling submission” application was submitted on Feb. 1, 2022 at the request of the U.S. Food and Drug Administration (FDA) […]
Myocarditis Risk Following mRNA COVID Shots May Be Far Higher Than Previously Estimated
A new study conducted by researchers from the U.S. Centers for Disease Control and Prevention (CDC) and several universities and hospitals in the United States shows that the risk of myocarditis (inflammation of the heart muscle) after receiving a messenger RNA (mRNA) COVID-19 biologic is 133 times greater than the normal risk for the condition […]
FDA to Release Pfizer Data, But the Devil Could Be in the Details
Last month, the U.S. Food and Drug Administration (FDA) asked a Federal Court Judge to allow the agency 75 years to release all the data upon which it licensed Pfizer’s COVID-19 vaccine (Comirnaty). Earlier this month the FDA’s request was rejected. The drug regulator had originally stated that it could only produce 500 pages per […]
Sales of Pfizer COVID-19 Biologic for 2021-2022 May Near $70 Billion
Based on better than expected sales of its experimental messenger RNA (mRNA) BNT162b2 COVID-19 biologic, New York-based pharmaceutical company Pfizer, Inc. last summer revised projected sales of its experimental drug, also known as “Comirnaty,” from $26 billion to $33.5 billion in 2021. Characterizing second-quarter sales of BNT162b2 as “remarkable,” Pfizer’s chief executive officer (CEO) Albert […]
