“You may choose to look the other way, but you can never say again that you did not know.”
— William Wilberforce
The great martial artist Bruce Lee reputedly said that all mistakes are forgivable—if one has the courage to admit the mistake. Paul Fenyves, a primary care physician in New York City who specializes in internal medicine, seems to have learned this lesson. Fenyves, a primary care doctor at Weill Cornell Medicine, recently admitted he was wrong to […]
We all know that mRNA vaccines are associated with myocarditis. It’s rare, but it’s an important safety signal. It’s more likely to affect men than women, and it’s more likely to affect people in a certain age range. And that range is about 16 to 24. That’s the peak demographic. And it’s still important from […]
On Oct. 12, 2022, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of the COVID bivalent booster versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID for children as young as five or six years old, respectively. The FDA’s decision on Aug. 31 to grant […]
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 […]
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 […]
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 […]
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 […]