Several vaccines have been developed since the onset of the COVID-19 pandemic. The FDA requires evidence from a Phase 3 clinical trial before approving any new vaccines. As a statistician in training, you will examine results from the clinical trial report by Polack et al. (2020) to answer the following questions.
Polack, Fernando P., Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." New England Journal of Medicine (2020).
(a) (10 pts) Find and download this paper.
(b) (10 pts) Is this study experimental, observational, or mixed? Explain.
(c) (10 pts) What is the basic unit in this study?
(d) (10 pts) What is the treatment in this study?
(e) (10 pts) What are the primary endpoints in this study?
(f) (10 pts) Explain whether it is possible to test the effect of vaccines on the primary endpoints in this study.