Health Communication Lecturer at IDC Herzliya International School Dr. Yaffa Shir Raz today responded to the FDA briefing document on Pfizer’s COVID-19 vaccine trials that reveals scores of test subjects went “lost” during the research, blasting the “lack of transparency” and claiming that the lapse renders the results suspect.
Shir Raz wrote: “Another crucial matter that arises from the FDA report is that during the experiment, after the first and/or second dose, 80 participants in the experiment group and another 86 in the placebo group went “lost” to the investigators.
“What do you mean they ‘went lost’, you ask?
“Well, literally – gone.
“End of story.
“Their traces are lost.
“The big question, that needs to greatly bother the researchers and certainly the FDA experts – is what happened to the fate of those 80 participants in the immune group?
“How can you tell if everyone is alive, safe, and sound?
“And why didn’t the researchers continue to follow them, also (and maybe specifically) if they dropped out of the research after they were already vaccinated?
“Let’s even assume that only one or two of them died a month later, or suffered serious side effects (or if they G-d forbid will occur in the future) – it could be crucial to the result. Why didn’t the follow-up continue after them? Why didn’t the investigators find out what became of their fate?
“This item is mentioned in the table presented in the FDA report, but for some reason – there is no reference to it in the data review.
“Transparency is definitely not the name of the game here!”, Shir Raz concluded.
The FDA briefing document says:
“188.8.131.52.3. Deaths in Study C4591001 Phase 2/3
“There were 6 participants, all in Phase 3, who died through the data cutoff date of 14 November 2020. This included 2 participants in the BNT162b2 group and 4 participants in the placebo group. None of these deaths were assessed by the investigator as related to study intervention.
“Details of the 6 reported deaths among all enrolled participants include:
- One participant in the older BNT162b2 group experienced an SAE (severe adverse event) of arteriosclerosis and died 3 days after Dose 1.
- One participant in the older BNT162b2 group experienced an SAE of cardiac arrest 60 days after Dose 2 and died 3 days later.
- One participant in the younger placebo group experienced an SAE of unevaluable event (unknown of unknown origin; no additional information currently available at the time of this report) 8 days after Dose 1 and died the same day.
- One participant in the older placebo group experienced an SAE of hemorrhagic stroke 15 days after Dose 2 and died the next day.
- One participant in the younger placebo group experienced an SAE of death (cause unknown; no additional information currently available at the time of this report) 34 days after Dose 2.
- One participant in the older placebo group experienced an SAE of myocardial infarction 16 days after Dose 1 and died the same day.”
Shir-Raz thanked Dan D. Aridor for the find.
השאלה הגדולה, שצריכה להטריד מאוד את החוקרים ובוודאי את מומחי ה-FDA – היא מה עלה בגורלם של אותם 80 משתתפים בקבוצת החיסון? pic.twitter.com/MaZhFd4FBL
— Yaffa Shir-Raz (@YaffaRaz) December 9, 2020
Source: Mordechai Sones – Sheva