Drugs

Reject Covid Vaccine Challenge Trials: Public Citizen

Public Citizen has written to HHS secretary Alex Azar, FDA commissioner Stephen Hahn, National Institutes of Health director Francis Collins, and National Institute of Allergy and Infectious Disease director Anthony Fauci asking HHS to announce that FDA will not permit and NIH will not support any clinical trial in which human subjects that have been immunized with an investigational coronavirus 2 vaccine are intentionally infected with the novel coronavirus that causes Covid-19. “This important policy decision is consistent with a recommendation by an NIH-funded advisory group published last week,” a 7/6 letter says.

The advocacy group says that “challenge studies” have been promoted as a way to shorten the timeline for vaccine development and approval.

“To our knowledge, not one of the many SARS-CoV-2 vaccine development programs involves plans to intentionally infect volunteers with the novel coronavirus,” Public Citizen says. “The most important disqualifying reason against such potentially dangerous and unethical studies is the lack of any evidence that such studies will accelerate overall vaccine development.”

The letter concludes that there is a pressing need for the four officials to (1) mitigate future pressure from members of Congress for coronavirus challenge studies and (2) reduce the numbers of similarly misinformed people volunteering to be infected with SARS-CoV-2 who now mistakenly believe that infecting humans in such studies is acceptable because it would lead to accelerated vaccine development and approval by explicitly discouraging such unethical studies.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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