Biologics

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

The FDA has opened a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines, expanding a review that previously appeared focused only on pediatric cases. The agency says multiple divisions are now examining deaths “potentially related to Covid vaccines” across all age groups, according to a Bloomberg article. FDA did not disclose how many cases are under review, which products are involved, or any medical details, citing the need to protect ongoing analyses.

The move follows recent Covid vaccine scrutiny prompted by an internal memo from CBER director Vinay Prasad (see story) that claimed a review had identified at least 10 child deaths “after and because of” vaccination. FDA has not publicly released the underlying data and has not confirmed the memo’s conclusions.

Bloomberg notes that large observational studies conducted by the CDC and external researchers have previously found no evidence of increased mortality following mRNA vaccination. Regulators and epidemiologists have repeatedly cautioned that adverse-event reporting systems collect unverified submissions that do not establish causality.

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