Reference:
Pfizer. (2023). NCT04368728 FDA Clinical Trial: C4591001. Retrieved from [link to the document]
Summary:
The clinical trial NCT04368728, with protocol number C4591001, aims to evaluate the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals. The trial is structured in three phases, assessing different doses and age groups, with significant adjustments made to the protocol, including 44 version changes. Originally designed for adults aged 18-85, it has now included participants aged 12-18. The trial incorporates a placebo-controlled, observer-blind design to ensure objective results. Concerns have arisen regarding the integrity of data due to changes in study parameters and
the inclusion of younger age groups without sufficient safety data. The final candidate selected for efficacy evaluation is BNT162b2 at a dose of 30 µg. Safety measures and monitoring protocols are critical throughout the study to protect participants and uphold data integrity.