Pfizer Argentina Requests “Clarifications”, Possible Changes in Records Related to Death of Clinical Trial Subject
Son necesarias algunas aclaraciones del paciente 12314987, study C4591001.
Regarding the information provided in the literature publication from International Journal of Vaccine Theory, Practice, and Research, 2023, vol 3 entitled Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial.
-Please clarify the correct event term, as the FU# indicated it as “Cardio-respiratory arrest” and had previously been indicated as “Cardiac arrest”.
-Please clarify the number of days between the application of the vaccine dose and the death of the patient due to the fact that the document received indicates 2 different amounts (Days Post Dose 1: 101 days and He received the placebo and died 82 days after).
-Please also confirm the dose number applied due to in case the dose 2 was added as suspect, but according to this report, the patient died after receiving dose 1.
-The events abdominal pain, vomiting, and back pain were reported in this follow-up, please confirm if these should be added as additional events and if so, please provide a new SAE form including causalities.
-Please confirm whether or not an autopsy was performed because in the case it was indicated as “yes” but in this follow-up it was stated “No record of an autopsy is available and the family was not responsive to inquiry.”
Les agradeceríamos que por favor, contesten esta consulta lo antes posible en un nuevo SAE Form y lo envíe por e-mail o por fax al 4788-7003.
Me encuentro a su disposición ante cualquier consulta.
Drug Safety Unit
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