Biologics

FDA Denies ICAN Petition on J&J Covid Vaccine

FDA has denied a 3/23/21 petition for reconsideration submitted by the Informed Consent Action Network (ICAN) concerning the agency’s denial of ICAN’s 10/16/20 original petition asking it to amend the study design for a Phase 3 trial of Johnson & Johnson’s Covid-19 vaccine. The reconsideration petition asserted that FDA’s response to the original petition did not adequately consider all the relevant safety concerns regarding the vaccine.

In its 5/12 denial letter, FDA says the changes called for in ICAN’s original petition were to document all adverse events, document adverse events for specified periods of time, amend the study sample size, amend the study design to provide that participants are tested for T-cell reactivity, amend the study design to provide that germline transmission tests are conducted for male participants, and to amend the study design to provide for HIV incidence monitoring.

“FDA denied the original petition finding that with respect to each request, the original petition did not contain facts demonstrating any reasonable ground for the requested action,” the reconsideration denial says. “FDA’s response included extensive discussion of the relevant scientific issues.”

The agency letter reviews the four criteria stated in the law that govern approval of a request for reconsideration, including a demonstration that relevant information or views contained in the administrative records were not previously or not adequately covered.

“We find that you have failed to demonstrate that relevant information or views contained in the administrative record were not previously or adequately considered…,” FDA says. “Because you have failed to demonstrate this criterion, we need not address the other criteria….”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome