Friday, November 27, 2020 1:49:08 PM
https://www.pfizer.com/clinicalprotocol
I'm not sure I'm reading it correctly, but maybe Pfizer/Biontech also takes asymptomatic cases into efficacy consideration?
Page 55, Chapter 8.1:
"In addition, a serological definition will be used for participants without clinical presentation of COVID-19:
• Confirmed seroconversion to SARS-CoV-2 without confirmed COVID-19: positive N-binding antibody result in a participant with a prior negative N-binding antibody
result
Serum samples will be obtained for immunogenicity testing at the visits specified in the SoA.
The following assays will be performed:
• SARS-CoV-2 neutralization assay
• S1-binding IgG level assay
• RBD-binding IgG level assay
• N-binding antibody assay"
I'm not sure I'm reading it correctly, but maybe Pfizer/Biontech also takes asymptomatic cases into efficacy consideration?
Page 55, Chapter 8.1:
"In addition, a serological definition will be used for participants without clinical presentation of COVID-19:
• Confirmed seroconversion to SARS-CoV-2 without confirmed COVID-19: positive N-binding antibody result in a participant with a prior negative N-binding antibody
result
Serum samples will be obtained for immunogenicity testing at the visits specified in the SoA.
The following assays will be performed:
• SARS-CoV-2 neutralization assay
• S1-binding IgG level assay
• RBD-binding IgG level assay
• N-binding antibody assay"
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