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) […]
U.S. Hospitals May ‘Recalculate’ How They Report COVID Cases
Perhaps influenced by the lifting of COVID-19-related restrictions by several European countries—starting with Denmark—during the past two weeks, the United States seems to be on the verge of following Europe’s lead in declaring the pandemic over. In a recent interview with the Financial Times, White House chief medical advisor and director of the National Institute […]
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 […]
Testing Will Not Save Us
I have heard many people say that at this moment—January 2022—testing will save us. They cite success stories like the National Basketball Association’s bubble (of 2020) to show what testing can accomplish. Unfortunately, here are nine considerations that they are missing when it comes to mass testing. 1. No one has any tests. There are […]
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.