Biologics

Novavax Covid Vaccine Showed Myocarditis Safety Signal: FDA

An FDA advisory committee briefing document says that Novavax’s Covid-19 vaccine’s two-dose primary series demonstrated significant efficacy, but it also showed similar risk signals seen with other Covid vaccines, such as myocarditis/pericarditis. The agency’s Vaccines and Related Biological Products Advisory Committee is being convened 6/7 to discuss and provide recommendations on whether the benefits of Novavax’s vaccine outweigh its risks for use in individuals 18 years of age and older.

According to the briefing document, vaccine efficacy against confirmed mild, moderate or severe Covid-19 was 90.4%. “All Covid-19 cases in the [Novavax] arm were mild; in the placebo arm, 11% of cases were moderate and 5% were severe. FDA notes that when data were collected in 2021 the predominant circulating Covid-19 strain was the B.1.1.7 (Alpha) variant.

On the safety side, FDA said: “Multiple events of myocarditis/pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA Covid-19 vaccines and raising concern for a causal relationship to NVX-CoV2373. Events of lymphadenopathy were infrequent but reported by a higher proportion of participants in the NVX arm, with the highest rate observed after Dose 2 (0.2%). Review of the data also identified small imbalances in certain thromboembolic events, including cardiac and neurovascular events, hypersensitivity events, cholecystitis, uveitis, cardiac failure, and cardiomyopathy. However, a causal association between vaccination and these events cannot be concluded based on available data.”

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