@MYTH@bubu :
 

Donc comme je l’ai dit seul ceux qui préparaient et injectaient le produit n’était pas aveugle, mais ils ne faisaient rien d’autre dans l’essai.

 
A. Vous ne connaissez pas le protocole
B. Vous ne connaissez pas la définition du double-blind.
 
Je vous ai déjà suggéré de vous renseigner, mais vous avez préféré m’ignorer.
Donc, on va procéder en trois temps (Définition, Protocole, Explication) afin de pouvoir arriver à la Conclusion

 
1. Définition :

A double-blind trial is one in which neither the subject nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects are aware of the treatment received. This includes anyone determining subject eligibility, evaluating endpoints, or assessing compliance with the protocol. This level of blinding is maintained throughout the conduct of the trial, and only when the data are cleaned to an acceptable level of quality will appropriate personnel be unblinded. If any of the sponsor staff who are not involved in the treatment or clinical evaluation of the subjects are required to be unblinded to the treatment code (e.g. bioanalytical scientists, auditors, those involved in serious adverse event reporting), the sponsor should have adequate standard operating procedures to guard against inappropriate dissemination of treatment codes. The double-blind trial is the optimal approach. This requires that the treatments to be applied during the trial cannot be distinguished (appearance, taste, etc.) either before or during administration, and that the blind is maintained appropriately during the whole trial.
ICH Topic E 9 - Statistical Principles for Clinical Trials
NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS (CPMP/ICH/363/96)

Repris dans Clinical Trials Handbook, Edited by Shayne Cox Gad, Ph.D., D.A.B.T., Gad Consulting Services, Cary, North Carolina, John Wiley & Sons, Inc, 2009 - p. 250
 
2. Protocole
 
An external data monitoring committee (DMC) will be formed and will review cumulative unblinded data throughout the study.
a DMC will conduct unblinded reviews on a regular basis throughout the trial
sponsor staff will be unblinded to vaccine allocation
analyzed by the unblinded statistical team
The following sponsor stafff will be unblinded in Phase 2/3
Those study team members who are involved in ensuring that protocol requirements for study intervention preparation, handling, allocation, and administration are fulfilled at the site will be unblinded for the duration of the study
Unblinded clinician(s), who are not direct members of the study team and will not participate in any other study-related activities, will review unblinded protocol deviations.
An unblinded team supporting interactions with, and analyses for, the DMC
An unblinded submissions team will be responsible for preparing unblinded analyses and documents to support regulatory activities that may be required while the study is ongoing.
the sponsor will conduct unblinded reviews of the data during the course of the study
the unblinded team supporting the DMC, including an unblinded medical monitor, will review cases of severe COVID-19
the unblinded team may discuss with the DMC chair
Because the BNT162 RNA-based COVID-19 vaccine candidates and placebo are different in physical appearance

 
3. Explication :
 

Donc comme je l’ai dit seul ceux qui préparaient et injectaient le produit n’était pas aveugle, mais ils ne faisaient rien d’autre dans l’essai.

Dans cet essai, le patient ne sais pas ce qu’il reçoit, celui qui injecte sait (et il ne fait rien d’autre dans l’essai clinique), ceux qui évaluent les effets secondaires et tous le reste du personnel médical de l’essai ne savent pas non plus.

L’essai peut donc être considéré comme du double aveugle. Le terme double aveugle est vague et regroupe plusieurs definitions.

 
Comme votre explication ne correspond pas au Protocole, la Conclusion est que vous êtes dans l’erreur.
 
Cependant, je ne peux pas vous empêcher de contacter Pfize® et le NEJM afin de leur proposer votre explication. Hésitez-pas à revenir avec leur réponse !
 
Bonne chance !