Letter: Federal Government’s Plan to Expedite Coronavirus Vaccine Use Would Put Americans at Risk, Lead to Loss of Confidence

Most Americans Likely Wouldn’t Take Unapproved Vaccine

WASHINGTON, D.C. – The U.S. Department of Health and Human Services (HHS) must abandon their consideration of an emergency use authorization to expedite widespread distribution and use of a potential coronavirus vaccine and wait for complete data that ensures such a vaccine is safe and effective, Public Citizen said today in a letter to the agency and top federal health experts.

U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn and Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, have recently discussed the possibility of using such an emergency use pathway instead of the full normal approval process to allow massive distribution of a vaccine after only preliminary data are evaluated by the agency. No vaccine for mitigating or preventing pandemics or epidemics of infectious disease has ever been distributed without full FDA approval based on a thorough evaluation of data from completed clinical trials.

Such a pathway for a vaccine candidate was last considered in 2009 during the swine flu pandemic, and a nationwide survey that year found that when asked if they would take “a new, but not yet approved vaccine,” 64% of Americans said they would not take it.

“In addition to serious efficacy and safety concerns about releasing an incompletely tested and evaluated vaccine to the public, fewer people will likely be willing to be vaccinated because of decreasing public trust in vaccines and the FDA,” said Sidney Wolfe, founder of Public Citizen’s Health Research Group and lead author of the letter.

In addition to HHS Secretary Alex Azar, Hahn and Marks, the letter was sent to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Read the letter here.