This article about the Informed Consent Action Network’s petition to halt the JNJ COVID-19 vaccine trial was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law.
This is a summary of the FDA’s response to a citizen petition dated October 16, 2020, filed on behalf of the petitioner, Del Bigtree’s Informed Consent Action Network (ICAN), relating to the clinical trial of Ad26.COV2S, a Janssen Biotech, Inc. (a subsidiary of Johnson & Johnson, JNJ) COVID-19 vaccine.
Like a previous ICAN petition about COVID-19 vaccine trials, the FDA denied the petition in its entirety. FDA concluded that the vaccine trials were thorough, vaccine safety was carefully tested and monitored, and ICAN’s requests are not well-founded.
This summary is divided into three parts: (1) ICAN’s specific requests; (2) FDA’s description of the vaccine process and safety; and (3) FDA’s response to six specific requests.Continue reading “JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition”