FDA Claims Licensed Vaccines Do Not Need to Prevent Infections or Transmission

Recently, during the Food and Drug Administration (FDA) contemplated changes to the COVID-19 vaccine status, they elicited a commenting period. An organization called the Coalition Advocating for Adequately Labeled Medicines (CAALM) tracked by TrialSite News filed a petition requesting that the agency update the COVID-19 vaccine product labeling –for both Pfizer and Moderna products—to reflect their actual safety and efficacy more accurately. The third entry was titled “Requests that the FDA require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccines (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling.” While the principals behind CAALM are experts and offer the FDA valid points in their comments, the FDA flatly rejects the organizations requests, declaring that a licensed vaccine doesn’t need to demonstrate that they prevent infection or transmission nor does a vaccine authorized under provisional emergency use authorization need to demonstrate infection prevention or transmission. ------------------------------------ Join The Conversation! |