FDA panel votes for rotavirus vaccine

Article

The Food and Drug Administration has made the approval of GlaxoSmithKline's rotavirus vaccine all but official, having its advisory panel vote in favor of the vaccine...

The Food and Drug Administration has made the approval of GlaxoSmithKline's rotavirus vaccine all but official, having its advisory panel vote in favor of the vaccine.

GlaxoSmithKline submitted 11 studies on the oral vaccine Rotarix, which if approved would help prevent the dehydrating diarrhea in infants associated with the rotavirus disease. The panel voted 11-1 in favor of the oral vaccine.

Almost every time the FDA's advisory panel has approved a drug or vaccine, it has gone on to approve the drug. There was a statistically significant increase in pneumonia deaths associated with the vaccine, but GlaxoSmithKline argued the deaths came from a single trial, and weren't indicative of real-world results.

Rotarix is already approved in some countries.

Newsletter

Access practical, evidence-based guidance to support better care for our youngest patients. Join our email list for the latest clinical updates.

Recent Videos
John Browning, MD, provides practical skincare reminders ahead of summer season
Contemporary Pediatrics: RX Review: Updates and Unmet Need in RSV thumbnail
Contemporary Pediatrics: RX Review: Updates and Unmet Need in RSV thumbnail
Contemporary Pediatrics: RX Review: Updates and Unmet Need in RSV thumbnail
Staphylococcus aureus risk in infants and neonatologist considerations with Aaron Milstone, MD
How fragrance plays a role in atopic dermatitis treatments, with John Browning, MD
Octavio Ramilo, MD, reacts to the FDA approval of clesrovimab for RSV prevention | Image Credit: St. Jude Children's Research Hospital
© 2025 MJH Life Sciences

All rights reserved.