The case reports included in Pfizer clinical trial documents, released June 1 by the U.S. Food and Drug Administration, reveal a trend of classifying almost all adverse events - and in particular severe adverse The latest release by the U.S. Food and Drug Administration of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials.
The 80,000-page document cache includes an extensive set of Case Report Forms from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
Specifically, in this portion of the study, "two participants in the BNT162b2 30 μg younger age group and 1 participant in the BNT162b2 30 μg older age group reported at least 1 severe AE," and "in the BNT162b2 30 μg younger age group, 3 participants reported at least 1 related AE and 1 participant reported 1 severe SAE.".
The review adds, "from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE that was assessed by the investigator as not related to study intervention," and "there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.".
"While "Incidences in the BNT162b2 and placebo were similar within the age groups for younger and older participants, among those who received BNT162b2 instead of the placebo,"two severe events of myalgia and gastric adenocarcinoma were reported for 2 participants in the younger age group, both assessed by the investigator as not related to study intervention.
"An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that "Was assessed by the investigator as related to study intervention; specifically,"an anaphylactoid reaction 2 days post Dose 3" leading to the participant's withdrawal from the study, despite a reported resolution.
"The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date, was mostly reflective of reactogenicity events with low incidences of severe and/or related events.
The 80,000-page document cache includes an extensive set of Case Report Forms from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
Specifically, in this portion of the study, "two participants in the BNT162b2 30 μg younger age group and 1 participant in the BNT162b2 30 μg older age group reported at least 1 severe AE," and "in the BNT162b2 30 μg younger age group, 3 participants reported at least 1 related AE and 1 participant reported 1 severe SAE.".
The review adds, "from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE that was assessed by the investigator as not related to study intervention," and "there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.".
"While "Incidences in the BNT162b2 and placebo were similar within the age groups for younger and older participants, among those who received BNT162b2 instead of the placebo,"two severe events of myalgia and gastric adenocarcinoma were reported for 2 participants in the younger age group, both assessed by the investigator as not related to study intervention.
"An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that "Was assessed by the investigator as related to study intervention; specifically,"an anaphylactoid reaction 2 days post Dose 3" leading to the participant's withdrawal from the study, despite a reported resolution.
"The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date, was mostly reflective of reactogenicity events with low incidences of severe and/or related events.
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