ENXTPA:SANPharmaceuticals
Sanofi (ENXTPA:SAN) Halted Its Phase 3 RSV Vaccine Trial
Sanofi (ENXTPA:SAN) halted a Phase 3 RSV vaccine trial in infants and toddlers after the death of a participant linked to an undiagnosed congenital heart defect.
The company reported an overall acceptable safety profile in the trial with no cases of vaccine associated enhanced respiratory disease identified.
The pause has drawn attention to inclusion and exclusion criteria in pediatric vaccine studies and to how closely clinical trial protocols are followed.
Regulators and investors are...