Comirnaty - first boost (n=5081) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=5044)
randomized controlled trial
low risk of bias
BNT162b2 vaccine
third dose
placebo
participants had previously received 2 doses of Comirnaty
COVID-19 prophylaxis (excluding children)
single-blind
123 sites in the United States, South Africa, and Brazil
During the interim analysis, the data monitoring committee recommended that participants be made aware of their trial-group assignments to allow those in the placebo group to receive a third vaccine dose. Data from participants who were made aware of trial-group assignments before the first interim analysis because of the regulatory decision were censored at the time of the unblinding of the trial group.
Pfizer/BioNTech Booster study, 2021 NCT04713553
first booster dose (n=-9) vs. complete primary vaccine series (n=-9)
randomized controlled trial
risk of bias NA
30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine
The median time between second dose and administration of the booster dose or placebo was approximately 11 months.
Placebo
COVID-19 prophylaxis (excluding children)
Double-blind.
Data extracted from press realease: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing