Sen. Johnson to DoD, FDA, CDC:Whistleblower Allegations about COVID-19 Vaccine Mislabeling and Unauthorized Manufacturing Must be Fully Addressed
August 19, 2022
Part 1 of 2
WASHINGTON – On Thursday, U.S. Sen. Ron Johnson (R-Wis.) sent a letter to Department of Defense (DoD) Secretary Lloyd Austin, Food and Drug Administration (FDA) Commissioner Robert Califf, and Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky regarding concerns about mislabeling and unauthorized manufacturing connected to COVID-19 vaccines at military bases.
Nine DoD whistleblowers disclosed to Congress that at least one vaccine lot number—FW1331—was manufactured at a location that was not FDA approved. These whistleblowers also alleged that this lot number, which was printed on a vaccine vial labeled “Comirnaty,” appeared on a CDC database that lists Emergency Use Authorization (EUA) vaccine lot numbers.
The senator wrote, “DoD, FDA, and CDC must provide a thorough explanation for why a vaccine lot with the ‘Comirnaty’ label would be listed on a database that is meant to display vaccine lots associated with the EUA.”
The full text of the letter can be found here and below.
August 18, 2022
The Honorable Lloyd J. Austin III
Secretary of Defense
U.S. Department of Defense
The Honorable Robert M. Califf, MD
Commissioner
Food and Drug Administration
Rochelle P. Walensky, MD, MPH
DirectorCenters for Disease Control and Prevention
Dear Secretary Austin, Commissioner Califf, and Director Walensky:
Nine Department of Defense (DoD) whistleblowers recently provided my office with information that raises questions about the manufacturing and labeling of COVID-19 vaccines distributed to service members.[1] These new whistleblower allegations must be fully addressed by DoD, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).
Lt. Chad Coppin, who is a commissioned officer in the U.S. Coast Guard, disclosed that on June 10, 2022, his base located in Juneau, Alaska received “a shipment of 60 Comirnaty vials packaged in six boxes of ten vials.”[2] These vials included the vaccine lot number FW1331.[3] Lt. Coppin noted that, “[p]rior to this date, only emergency use authorization shots [had] been available[.]”[4] Lt. Coppin provided my office with pictures of one of the Comirnaty vials and boxes his base received:
https://www.ronjohnson.senate.gov/2022/8/sen-johnson-to-dod-fda-cdc-whistleblower-allegations-about-covid-19-vaccine-mislabeling-and-unauthorized-manufacturing-must-be-fully-addressed
Whistleblowers letter