Biologics

Explain FDA Vaccine Approval Process: Study

A study by the Annenberg Public Policy Center of the University of Pennsylvania finds that people are more likely to recommend that a pregnant family member or friend be vaccinated to protect the infant from respiratory syncytial virus (RSV) if they are shown a chart outlining the FDA vaccine approval process. A statement (includes a link to the research report) says 57% of those in a group exposed to a flowchart of the vaccine approval process were very or somewhat likely to recommend the vaccine to a pregnant family member or friend, compared with 40% of those in a control group not shown the chart. In a group whose members were informed about the risks of RSV, 58% were more likely to recommend the vaccine.

The statement notes that FDA has not yet approved an RSV vaccine for pregnant women; vaccines have been approved for adults aged 60 and older.

The report makes these recommendations for public health officials and others who communicate with the public about ways to minimize public susceptibility to misinformation about RSV and vaccination:

increase public understanding of the FDA review process;
preemptively communicate about the changing nature of science by including caveats indicating that the guidance on RSV will be updated as more is learned about the vaccine;
visually represent the effects of RSV and offer clear and accurate information about the risks and benefits of vaccination compared with the likelihood of infection and its risks;
the Centers for Disease Control should create a Web page that complements existing information on RSV and focuses on vaccination during pregnancy.

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

Read more

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