Biologics

FDA Approves RSV Vaccine for Pregnant Women

FDA has approved a new indication for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in infants from birth through six months of age. An agency statement says Abrysvo is approved for use at 32 through 36 weeks of gestational age of pregnancy. It is administered as a single dose injection into the muscle. The vaccine was previously approved in May to prevent LRTD caused by RSV in individuals aged 60 and older.

FDA says the vaccine’s effectiveness was established in a clinical trial in which it reduced the risk of severe LRTD by 81.8% within 90 days after birth and 69.4% within 180 days after birth. Abrysvo’s safety was evaluated in two studies. The most commonly reported side effects by pregnant individuals who received Abrysvo were injection site pain, headache, muscle pain, and nausea. FDA reports that pre-eclampsia occurred in 1.8% of pregnant individuals who received the vaccine compared to 1.4% of pregnant individuals who received a placebo. “In the safety studies,” the statement says, “low birth weight and jaundice in infants occurred at a higher rate in the pregnant Abrysvo recipients compared to pregnant placebo recipients.”

The labeling contains a Warning that a numerical imbalance in preterm births in Abrysvo recipients (5.7%) occurred compared to those who received the placebo (4.7%). FDA says the available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo.

FDA says it is requiring Pfizer to conduct postmarketing studies to assess the signal of serious risk of preterm birth and to assess hypertensive disorders of pregnancy, including pre-eclampsia.

The application had been granted priority review and breakthrough therapy and fast-track designations.

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