Biologics

FDA Probes Flu Vaccine Shortcomings

FDA commissioner Scott Gottlieb says the agency is investigating why this year’s flu vaccine was not very effective against one strain — H3N2. “We’re taking steps to investigate each of [the] potential causes, rule out possible reasons for the variation in effectiveness and improve vaccine efficacy against H3N2,” he said in a statement. “Overall, preliminary vaccine effectiveness reported by Centers for Disease Control and Prevention (CDC) for H3N2 influenza was 25%, which means that people who received the vaccine were 25% less likely to be sick and need to see a doctor.”

Gottlieb says that future vaccines may require a higher amount of H3N2 antigen to elicit a proper immune response to that particular strain of influenza. “As I noted previously, the work conducted with CMS shows a preliminary finding that suggests the cell-based influenza vaccine might be somewhat more effective than the egg-based vaccine,” he explains. “We are working to follow up on that finding. We’re also combing through the data to see if there are other reasons for why this season’s vaccines were less effective against H3N2. Our scientists are currently working internally and collaborating with others inside and outside of the federal government to understand all of these findings.”

Meanwhile, Gottlieb notes that a 3/1 advisory committee meeting will discuss the composition of next season’s flu vaccines. He says the World Health Organization has recommended changing two of the strains currently contained in this year’s influenza vaccines for the Northern Hemisphere. Panel members at the meeting will determine if these recommendations should also apply for the U.S.

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