After 40 Years, Is Vaccine For Group B Strep On Horizon?

US FDA advisory committee debates possible endpoints to demonstrate vaccine effectiveness in maternal immunization; Pfizer, which has candidate in Phase I/II study, says use of surrogate endpoint of protection may be most feasible.

Render illustration of Clinical Trial title on medical documents

For researchers looking to develop a vaccine to prevent Group B streptococcus (GBS) disease in infants, the May 17 meeting of US FDA's Vaccines and Related Biological Products Advisory Committee was a significant step forward.

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

More from Vaccines

More from Pink Sheet

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.