Pfizer trial paper: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

URL

https://sci-hub.st/10.1056/NEJMoa2034577

Authors

Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, Gonzalo Pérez Marc, Edson D. Moreira, Cristiano Zerbini, Ruth Bailey, Kena A. Swanson, Satrajit Roychoudhury, Kenneth Koury, Ping Li, Warren V. Kalina, David Cooper, Robert W. Frenck, Jr., Laura L. Hammitt, Özlem Türeci, Haylene Nell, and Axel Schaefer

Published Date

December 10, 2020

Publication

New England Journal of Medicine (NEJM)

Organization

Pfizer, Inc.

Additional Information

Efficacy against SARS-CoV-2 transmission/infection and COVID-19 mortality were not endpoints (i.e., tested outcomes) of this study.

Research Summary
https://www.otaconline.org/application/files/8816/1256/1455/VaccineSummary.Polack.Pfizer.nejmoa2034577_research-summary.pdf

"Limitations and Remaining Questions

Further study is required to understand the following:

- Safety and efficacy beyond 2 months and in groups not included in this trial (e.g., children, pregnant women, and immunocompromised persons).
- Whether the vaccine protects against asymptomatic infection and transmission to unvaccinated persons."

Medium

document

Topics

clinical trial endpoints,clinical trials,COVID-19,FDA approvals,manufacturers,mRNA,vaccines