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 […]
Novavax’s Protein COVID-19 Vaccine Now Available in Europe
Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine has been authorized for distribution in the European Union (E.U.), making it the fifth COVID vaccine available for use in the E.U. Approved for people over 18 years old, Nuvaxoid is the first protein subunit COVID vaccine to be approved for use.1 2 The […]
Are Adverse Events in COVID-19 Vaccine Trials Under-Reported?
Phase III controlled trials are considered the ‘gold standard’ for assessing vaccine efficacy and safety in humans. These are the trials upon which authorities have assured the public that COVID-19 vaccines are “safe and effective.” The benefits of the vaccines in reducing disease severity and hospitalizations are well-known, but what do we know about the adverse events?Data on adverse events is vital for effective decision-making by regulators, policy makers, doctors, and patients.