Free Republic

The FDA has officially gone rogue. It just approved Moderna’s newest COVID-19 mRNA shot—mNEXSPIKE—without a single placebo-controlled trial, directly contradicting recent public assurances from HHS that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.” However, this authorization appears to align with their so-called “evidence-based approach to COVID-19 vaccination” published in NEJM —a policy that permits the continuation of mass experimentation on many Americans without clinical proof of benefit: FDA Unveils New Plan to Limit COVID-19 Vaccine Use — Keeps Deadly Program Alive NICOLAS HULSCHER, MPH · According to Moderna: The U.S. Food and Drug Administration...

Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000...