White House Blocks FDA’s Vaccine Guidance Document

Published Oct 19, 2020

What happened: The White House blocked the release of a Food and Drug Administration (FDA) guidance document, which detailed steps that pharma companies need to take to produce a safe and effective COVID-19 vaccine. The guidance document, which the White House eventually allowed to be published but only on the FDA’s website, required science-based checks to determine if a vaccine caused adverse health outcomes two months after vaccine administration and data to assess if the vaccine was effective against severe COVID-19 symptoms.

Why it matters: When government leaders fail to consider science in decisionmaking processes, public health and safety are put at-risk. Only with the development of a safe and effective COVID-19 vaccine will we able to slow the spread of COVID-19 around the world and protect millions of people from exposure to a deadly pathogen. However, people’s willingness to take a vaccine will be determined in large part by whether they trust the FDA to implement strong and rigorous scientific methodologies during vaccine development. The White House’s blocking of the guidance document, which was meant to convey transparency and public trust in the vaccine development process, is a chilling reminder of the willingness of political officials to politicize the vaccine and how such interference can further erode public trust in the vaccine development process.

Learn more about how White House officials delayed and blocked the release of the FDA’s vaccine guidance document.