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A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY …

A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY …
to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults This document and accompanying materials contain …

Pfizer and BioNTech Announce Publication of Results from …

Pfizer and BioNTech Announce Publication of Results from …
Dec 10, 2020 · Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and …

PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF …

PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF …
Pfizer BioNTech COVID-19 Vaccine is authorized for use under an EUA for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and...

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A Trial Investigating the Safety and Effects of Four BNT162 Vaccines ...

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines ...
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Here, we report safety and efficacy findings from the phase 2/3 part of a global phase 1/2/3 trial evaluating the safety, immunogenicity, and efficacy of 30 μg of BNT162b2 in preventing...

mRNA vaccines against COVID-19: Pfizer-BioNTech COVID …

mRNA vaccines against COVID-19: Pfizer-BioNTech COVID …
Two candidates of the mRNA vaccine were tested in Phase 1 trials: BNT162b1 and BNT162b2.

Pfizer, BioNTech begin phase 2/3 Covid-19 trial with BNT162b2 vaccine

Pfizer, BioNTech begin phase 2/3 Covid-19 trial with BNT162b2 vaccine
Preliminary clinical phase 1/2 data from nearly 120 patients showed a favourable overall tolerability profile for BNT162b2, as compared to BNT162b1, with generally mild to moderate …

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine ...

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine ...
Nov 18, 2020 · There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. To date, the …

A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE …

A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE …
In the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified. This amendment incorporates all revisions to date, including amendments made at the request …

FDA Review of Efficacy and Safety of Pfizer-BioNTech …

FDA Review of Efficacy and Safety of Pfizer-BioNTech …
Pfizer and BioNTech have proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA.