GSK Pauses RSV Vaccine Study In Pregnant Women Over Safety Concern
Delay Could Hand Advantage To Pfizer
Enrolment and dosing in a study of up to 10,000 women has been paused, leaving a worrying question mark over the vaccine’s safety.
You may also be interested in...
US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
New breakthrough therapy designations bolster Pfizer’s maternal RSV vaccine and Bavarian Nordic’s older adult program, while Sanofi/AstraZeneca prepare to submit nirsevimab BLA and GSK deals with fallout of safety-driven Phase III trial pause.
The company has not revealed any details of the potential safety issue that led to the decision.
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.