Sen. Johnson to DoD, FDA, CDC: Whistleblower Allegations about COVID-19 Vaccine Mislabeling and Unauthorized Manufacturing Must be Fully Addressed
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
Food and Drug Administration
Rochelle P. Walensky, MD, MPH
Centers 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. 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.” These vials included the vaccine lot number FW1331. Lt. Coppin noted that, “[p]rior to this date, only emergency use authorization shots [had] been available[.]” Lt. Coppin provided my office with pictures of one of the Comirnaty vials and boxes his base received:
Pictures of Comirnaty Vial (taken on June 10, 2022)
Pictures of Comirnaty Box (taken on June 10, 2022)
Lt. Coppin reported that he attempted to determine the shipping and manufacturing locations of these specific vaccines. He explained to my office that the medical staff at his base informed him that the vials were shipped from Ft. Detrick in Maryland. Lt. Coppin stated that he contacted Ft. Detrick to ask about the manufacturing location of the vials and was told that these vials came from a “Pfizer plant” located in Kalamazoo, Michigan.
Lt. Coppin then called Pfizer directly to ask about the manufacturing location of the specific vaccine lot number for these vials: FW1331. A Pfizer customer service representative apparently told him that this lot was manufactured in France on January 28, 2022 and expires on December 31, 2022. Lt. Coppin disclosed to my office that, “The significance of the France manufacturing location is that it is not an authorized manufacturing location as per the FDA’s Comirnaty [Biologics License Application (BLA)] Supplement Approval letter dated December 16, 2021.” That letter approved a “30 microgram dose formulation (Tris/Sucrose) of Comirnaty” to be manufactured at the “Pfizer Manufacturing Belgium NV, Purrs, Belgium facility.” Any Comirnaty vaccine lots that are manufactured outside of the FDA-approved manufacturing locations and distributed to U.S citizens raises significant legal and health-related concerns.
In addition to the lack of clarity relating to the manufacturing location of vaccine lot FW1331, another DoD whistleblower raised questions about whether this specific vaccine lot is mislabeled as “Comirnaty.” 1Lt. Mark Bashaw, who is a commissioned officer in the U.S. Army, found that the lot number contained on these “Comirnaty” vials—FW1331—matched a lot number on a CDC database listing Emergency Use Authorization (EUA) vaccine lots.
According to CDC, this database, which is called the COVID-19 Vaccine Lot Number and Expiration Date Report, “contain[s] all lots for COVID-19 vaccines made available under [EUA] for distribution in the United States.” 1Lt. Bashaw disclosed to my office that he downloaded this database and found that it included vaccine lot FW1331. 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.
Lt. Coppin, 1Lt. Bashaw, and the additional seven DoD whistleblowers who brought this information to my attention have exercised their right to talk to Congress. Any retaliatory actions taken against these individuals will not be tolerated and will be investigated immediately. DoD, FDA, and CDC owe our service members complete transparency regarding the COVID-19 vaccines that the Biden administration has forced upon them. With this in mind, I request that you provide the following information:
- Was vaccine lot FW1331 manufactured at the Pfizer facility located in Belgium? If not, why not?
- Why is vaccine lot FW1331, which is labeled “Comirnaty,” listed on a CDC database (“COVID-19 Vaccine Lot Number and Expiration Date Report”) for EUA vaccine lots?
- Was vaccine lot FW1331 created under the EUA? If so, why is it labeled “Comirnaty”?
- Please identify the vaccine lot numbers, in addition to FW1331, that are labeled “Comirnaty” and have been distributed to U.S. military bases and are also listed on CDC’s “COVID-19 Vaccine Lot Number and Expiration Date Report.”
Please provide this information as soon as possible but no later than September 1, 2022. Thank you for your attention to this matter.
 Letter from nine Dep’t of Defense whistleblowers, Aug. 15, 2022 (enclosed).
 Chad Coppin disclosure to Sen. Ron Johnson (on file).
 Letter from Jerry Weir, Food and Drug Administration, to Amit Patel, Pfizer Inc., Dec. 16, 2021, https://www.fda.gov/media/154939/download.
 Mark Bashaw disclosure (on file).
 COVID-19 Vaccine Lot Number and Expiration Date Report, Centers for Disease Control and Prevention, https://vaccinecodeset.cdc.gov/LotNumber.
 Mark Bashaw disclosure (on file).