Vaccine Decisions: US FDA And CDC Weigh New Vaccines For Diseases From Dengue To RSV
Executive Summary
Pink Sheet infographic tracks US regulatory forecast for the many new vaccines facing the twin tests of FDA approval and CDC recommendation, which are both needed to effectively access the US commercial marketplace.
You may also be interested in...
AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm
When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.
Keeping Track: Showers Of Approvals In US FDA’s May Forecast
Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.
FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval
Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.