This is a leaked internal document from Pfizer dated April 15, 2020. This document outlines the protocol for test subjects involved in trials of their mRNA COVID-19 vaccine. Please take note of Section 10.4.2. which discusses Women Of ChildBearing Potential (WOCBP) inclusion criteria. Great lengths are taken to eliminate women who may be pregnant or intend to get pregnant from the trials.
According to the Centers for Disease Control (CDC) website “Limited Data Are Available about the Safety of COVID-19 Vaccines for People Who Are Pregnant“.
*WOCBP: Women Of ChildBearing Potential
Safety and Immunogenicity of Two RNA-Based COVID-19 Vaccine Candidates PDF
This trial protocol has been provided by the authors to give readers additional information about their work.
Protocol for: Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19
vaccine candidates. N Engl J Med 2020;383:2439-50. DOI: 10.1056/NEJMoa2027906
