RE: Characterization of Factors Associated With Disease Severity in Adults Hospitalized With Respiratory Viral Infection: The Universal Study21 May 2024 15:28
You need to read the small print of the protocol, what was actually agreed. Here is what the Sprinter trial protocol, rubber stamped by the Regulator, says on page 46:
"6.13.2 blood sample for immunogenicity testing
A blood sample will be taken as per the study schedule for immunogenicity testing.
This will be completed in all sites, and for all patients, WHERE COLLECTION OF SAMPLES IS FEASIBLE. (1*)
If a site is not able to participate in immunogenicity sample collection, THIS WILL NOT PRECLUDE THEM IN THE STUDY."
(*1). Let's just assume they added that caveat understandably because Covid trials were happening in a time of unparalleled chaos in ICU's around the world. Many didn't have enough or any oxygen tanks, PPE, masks, never mind adequate blood sample kits and staff to do those samples - remember Italy, Argentina, etc?*
The company did not intend to do blood samples for all patients because they knew that was impossible across all sites in a rapidly changing and challenging pandemic situation - and they were correct. It was NEVER their intention to guarantee that, as stated in the protocol.