Biologics

Stop Trying to Prevent Covid in Healthy People: Offit

FDA Vaccines and Related Biological Products Advisory Committee member Paul Offit, who is affiliated with the Vaccine Education Center at Children’s Hospital of Philadelphia and the University of Pennsylvania’s Perelman School of Medicine, says a lesson learned from the experience with bivalent Covid-19 booster shots is to “stop trying to prevent all symptomatic infections in healthy young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later.” Writing in a New England Journal of Medicine Perspective column, Offit says booster dosing is probably best reserved for the people most likely to need protection against severe disease, such as older adults, people with multiple coexisting conditions that put them at high risk for serious illness, and those who are immunocompromised.

Offit notes that the mRNA vaccine technology-enabled companies to respond quickly to variant strains by creating bivalent vaccines. However, he says, research following the government push for bivalent boosters found little difference in effectiveness between them and the monovalent vaccines. And he says that any moderate increase in protection against probably mild disease from the bivalent boosters is likely to be short-lived.

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