1. Pink Sheet

As Vaccines Pipeline Gushes, Complex Communication Challenges Loom

 
• By Bridget Silverman

CDC Advisory Committee on Immunization Practices prepares for expected US FDA approvals of new vaccines to prevent respiratory syncytial virus in older adults, chikungunya and dengue and clarified recommendations for high-valent pneumococcal vaccines.

acip vaccine vaccine complicated
• Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Advisory Committee on Immunization Practices wrestled with the increasingly complicated recommendations associated with advances in vaccine development during its October meeting as the Centers for Disease Control and Prevention panel voted on updated pneumococcal vaccine recommendations and laid the groundwork for the expected approvals of candidates for chikungunya, dengue, and respiratory syncytial virus.

The vote that spurred the most public outcry, however, was the topic of some of the briefest discussion at the 19-20 October 2022 meeting

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.