Biologics

Vaccine Companies Pledge Scientific, Ethical Rigor

Nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory and ethical rigor as they conduct clinical trials and prepare regulatory submissions. The pledge, jointly made by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, is intended to reassure the public that vaccine development will follow FDA guidance and adhere to public health standards. The agency guidance clarifies that “scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations,” the companies acknowledge in their commitment.

Meanwhile, FDA commissioner Stephen Hahn was busy 9/8 reassuring the public that vaccine decisions will not be influenced by any political pressure and that only science and data will drive the agency’s decisions. “FDA’s professional staff will only authorize or approve a [Covid-19] vaccine if it meets the high standards that Americans expect for safety and effectiveness,” he said in a series of Twitter posts. “While FDA is committed to expediting this work, we will not cut corners.”

Hahn appears to be working in earnest to restore his credibility after recent missteps involving FDA’s emergency use authorization (EUA) for convalescent plasma (see earlier story). He had to walk back his exaggeration of data that supported the EUA after being widely criticized for stating that 35% of those treated with plasma would be saved.

With Covid-19 vaccines, Hahn says that FDA has “made clear through guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we know that some people have concerns about vaccine development efforts.” To learn more about the guidance, click here.

Additionally, Hahn has committed to an evaluation process that he promises will be as transparent as possible. “An FDA advisory committee of independent experts meets 10/22 to publicly discuss Covid-19 vaccine development,” his Twitter post says. “After specific candidate submissions, we’ll hold additional meetings.”

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