Biologics

FDA/CDC Dismiss ‘Signal’ with Pfizer Bivalent Vaccine

FDA and CDC say a recent potential safety signal suggesting Pfizer’s bivalent Covid-19 vaccine may cause ischemic stroke in people aged 65 and older has not been validated after looking at various vaccine clinical trial and surveillance databases. The agencies note that the signal has not been identified with Moderna’s bivalent Covid-19 vaccine.

The preliminary signal was detected in CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, and it met the statistical criteria to warrant additional investigations into whether there was a safety concern, the agencies say in a 1/13 notice.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” FDA and CDC say. The agencies say they will continue to evaluate additional data from other vaccine safety systems, and the issue will be discussed further at a 1/26 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee.

CDC continues to recommend that everyone aged six months and older stay up-to-date with Covid-19 vaccinations.

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