Biologics

Moderna Flu/Covid Vaccine Beats Comparators: Study

Moderna Phase 3 research found that its investigational mRNA-1083 combination flu and Covid-19 vaccine demonstrated noninferiority and induced higher immune responses than the recommended standard of care flu and Covid-19 vaccines in adults aged 50 and older. The company reported its research in the Journal of the American Medical Association.

The report says 8,015 participants were enrolled and vaccinated for the trial. The mRNA-1083 vaccine “was demonstrated to be at least as immunogenic as recommended standard of care vaccines against both seasonal influenza and Covid-19 and well tolerated in adults 50 years and older,” the study says.

The article cites advantages for the mRNA platform, including avoidance of egg adaptation-related changes and the breadth of immunity and T-cell responses for the influenza component. It also notes that the rapid production and flexibility for updates to vaccine composition can ensure close matching to circulating influenza and SARS-CoV-2 virus strains. It says the platform can quickly adapt to allow for timely and effective public health responses, especially in the face of emerging variants and strains.

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