[HTML][HTML] Grading of recommendations, assessment, development, and evaluation (GRADE): Pfizer-BioNTech COVID-19 vaccine
M Wallace - 2021 - stacks.cdc.gov
▪ Databases: Medline, Embase, and Cochrane Library, written in English, restricted to 2020▪
Search terms: coronavirus, COVID-19, SARS-CoV-2, respiratory (symptom, disease, illness,
condition), vaccine, immunization, trial, double blind, single blind, placebo, comparative
study, phase 3, immunogenicity, efficacy, effective, adverse, evidence, and variations on
these terms▪ Inclusion: provided data on vaccination with BNT162b2 and 1) involved human
subjects; 2) reported primary data; 3) included persons at risk for SARS-CoV-2 infection; 4) …
Search terms: coronavirus, COVID-19, SARS-CoV-2, respiratory (symptom, disease, illness,
condition), vaccine, immunization, trial, double blind, single blind, placebo, comparative
study, phase 3, immunogenicity, efficacy, effective, adverse, evidence, and variations on
these terms▪ Inclusion: provided data on vaccination with BNT162b2 and 1) involved human
subjects; 2) reported primary data; 3) included persons at risk for SARS-CoV-2 infection; 4) …
[HTML][HTML] Grading of recommendations, assessment, development, and evaluation (GRADE): Pfizer BioNTech COVID-19 vaccine
JW Gargano - 2021 - stacks.cdc.gov
▪ Inclusion: Relevant Phase 1, 2, or 3 randomized controlled trials of COVID-19 vaccine–1)
involved human subjects–2) reported primary data–3) included adults (age≥ 16 years) at
risk for SARS-CoV-2 infection–4) included data relevant to the efficacy and safety outcomes
being measured–5) included data for the dosage and timing being recommended (30 μg, 2
doses at 0 and 21 days)▪ Additional resources: unpublished and other relevant data by
consulting with vaccine manufacturers and subject matter experts
involved human subjects–2) reported primary data–3) included adults (age≥ 16 years) at
risk for SARS-CoV-2 infection–4) included data relevant to the efficacy and safety outcomes
being measured–5) included data for the dosage and timing being recommended (30 μg, 2
doses at 0 and 21 days)▪ Additional resources: unpublished and other relevant data by
consulting with vaccine manufacturers and subject matter experts