Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice?
With no safety and efficacy evidence from human clinical trials, on Aug. 31, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for Pfizer/BioNTech’s Comirnaty and Moderna/NIAID’s Spikevax messenger RNA (mRNA) COVID-19 biologics to distribute “bivalent formulations” (two-in-one) of the shots to use as a “single booster dose.”1 2 The […]
Why are Standards So Lax on COVID Drug Approvals?
Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet. First, consider that EUA ( emergency use authorization) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that […]
How Politics Corrupted Science: Dr. Vinay Prasad on COVID
As we’re entering this new phase of the pandemic, the CDC dropping its universal indoor masking guidelines at the end of February, we’re beginning to finally, at least some of us hope, look at this in the rearview, and I want to start with the big picture of what we see there and then move […]
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 […]
