Biologics

Chikungunya Vaccine on Pause Due to Safety Concerns

U.S. health officials have issued a temporary pause on the use of Valneva's chikungunya vaccine Ixchiq in individuals aged 60 and older following reports of serious adverse events, including two deaths. FDA and CDC say they are investigating 17 cases of severe side effects reported globally in adults aged 62 to 89 who received the vaccine, according to a safety alert.

Six of those cases were reported in the U.S., and most individuals affected had underlying chronic health conditions, the agencies say. The two fatalities included a case of encephalitis, a serious brain inflammation. Some of the adverse events mirrored severe complications of chikungunya disease itself, and several resulted in hospitalization.

The vaccine, which contains a live but weakened version of the chikungunya virus, was approved 11/2023 for adults 18 and older who are at risk of exposure.

The agencies note that earlier clinical trials involving around 3,500 participants showed common side effects such as headache, fatigue and joint pain. More severe and prolonged reactions — including those requiring hospitalization — occurred in a small number of recipients. Specifically, about 1.6% experienced severe symptoms that interfered with daily life, and some cases persisted for over 30 days, they say.

The agencies are collecting data as part of their investigation and recommend halting the vaccine’s use in older adults while a thorough benefit-risk assessment is conducted.

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