Henry Miller took another break from writing novels, this time to discuss the FDA's possible
black box warning on Covid-19 vaccines at SBM. He wrote, "For more than half a century, the FDA’s “black box” warning on drug labels has served as the agency’s strongest regulatory signal—a red flag reserved for medicines that carry a clear, serious, and well-established risk of death or irreversible harm. Opioids earn black boxes because they kill tens of thousands of Americans each year through addiction and overdose...Against that backdrop, the
reported plan by the FDA to impose a
black box warning on COVID-19 vaccines is not merely misguided—it would constitute professional malfeasance that risks undermining one of the greatest public-health achievements of the past century."
Dr Miller continued, "As Harvard regulatory expert Dr. Aaron Kesselheim has noted, black box decisions usually involve a discernible process: public notification, advisory committee review, and open discussion of the evidence. In this case, there has been no advisory committee, no publicly released analysis, and no explanation of what new data—if any—justify elevating COVID-19 vaccines into the FDA’s most dangerous category."
Of the Covid-19 vaccines he stated, "Before authorization, they were tested in randomized, placebo-controlled trials involving roughly 75,000 participants. After authorization, they were administered to
hundreds of millions of Americans and more than 13 billion people worldwide, with safety monitored through multiple overlapping systems: clinical trials, active surveillance networks, national registries, and pharmacovigilance programs across more than 90 countries...As Dr. Angela Rasmussen, a virologist and co-editor-in-chief of the journal
Vaccine, has noted, a black box warning signals that a product is inherently dangerous. That message would be broadcast not only to U.S. patients, but globally—handing anti-vaccine movements a powerful new talking point, stamped with FDA authority."
