Biologics

Speed Covid Vaccine Approval Process: Representatives

Some 35 members of the House of Representatives led by Reps. William Foster (D-IL) and Donna Shalala (D-FL) have written to FDA commissioner Stephen Hahn and HHS secretary Alex Azar asking them to consider conditions under which a Covid-19 vaccine might be approved and deployed more rapidly than under the usual approval process. “This consideration must rest on a rational analysis of the risk/benefit ratio, based on the best available science, and be free of political interference,” the 4/20 letter said.

The representatives (two Republicans, 33 Democrats) wrote that they want to assure the officials that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a Covid-19 vaccine. “In the case of accelerated human trials,” they said, “justifiable risks may be taken by parallel testing of multiple dose levels, advancing more rapidly from phase to phase, and potentially by challenging trials that involve deliberately using infected volunteers who have received candidate vaccines or placebos to confirm the efficacy of those vaccines and are at very low risk of serious disease from the infection. This could accelerate the emergency use and eventual licensure of vaccines that have also shown safety in larger groups by many months.”

The letter said that Congress has given the officials clear direction and funding to invest in multiple routes to mass production for multiple plausible vaccine candidates, in advance of their testing and approval, with the acknowledgment that much of the capacity will likely go unused when the final set of vaccines is chosen for mass deployment.

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