Drugs

Merck Wins Expanded Indication for Pneumococcal Vaccine

Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children and adolescents aged 2 to 17 years who have completed a primary pneumococcal vaccination series and are at increased risk for pneumococcal disease due to chronic medical conditions.

The action makes Capvaxive the only pneumococcal conjugate vaccine specifically studied and indicated in the U.S. for this high-risk pediatric population, according to the company. The vaccine is intended to provide additional protection against pneumococcal serotypes not included in currently approved pediatric pneumococcal vaccine series.

The expanded indication is supported by data from the Phase 3 STRIDE-13 trial, which demonstrated immune responses supporting the vaccine's use as a supplemental dose following completion of a primary pneumococcal vaccination series.

Pneumococcal disease can cause serious infections including pneumonia, meningitis and bloodstream infections, with children who have chronic heart, lung, kidney and other medical conditions facing elevated risk.

Capvaxive is described as a single-dose 21-valent pneumococcal conjugate vaccine. It was originally developed for adults and includes coverage against 21 pneumococcal serotypes, including eight not found in other approved pneumococcal conjugate vaccines. The vaccine is already approved in adults for the prevention of invasive pneumococcal disease and pneumococcal pneumonia.

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