In a letter to leadership at the U.S. Department of Defense (DoD), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC), U.S. Sen. Ron Johnson (R-WI) revealed nine whistleblowers had disclosed concerns of mislabeling and unauthorized manufacturing of COVID-19 vaccines.
Specifically, this illegal manufacturing was said to have involved military bases, and the whistleblowers – all from DoD – alleged to Congress that at least one lot number, FW1331, was manufactured at a non-FDA-approved site. Despite this, the Comirnaty-labeled lot appeared on a CDC database listing Emergency Use Authorization (EUA) vaccine lot numbers.
In a memorandum to Congress, accompanied by photos, the whistleblowers called the case one of potential fraud and a violation of labeling requirements. They accused the DoD of unlawfully administering EUA products as if they were fully licensed FDA-approved products since at least Aug. 24, 2021, refusing military members a legal right to refuse EUA products.
In response to these accusations, Johnson dispatched a letter to Defense Secretary Lloyd Austin III, FDA Commissioner Dr. Robert Califf, and CDC Director Dr. Rochelle Walensky.
“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,” Johnson wrote. “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.”
Subsequently, Coppin said that the medical staff at his base informed him that the vials were shipped from Ft. Detrick in Maryland and was told the vials were produced by a Pfizer plant in Kalamazoo, Mich. Pfizer claimed it was manufactured in France at a site that would not have been among the FDA’s authorized manufacturing locations for Comirnaty at that time. Separately, 1st Lt. Mark Bashaw discovered the lot match in the CDC database.
While denouncing the Biden administration for supposedly forcing vaccines on servicemembers, Johnson requested that the respective federal agencies answer for where the vaccine lot was manufactured, why it is in a CDC database, whether it was created under the EUA and what other vaccine lot numbers with Comirnaty labels were given to U.S. military bases. He set a deadline of Sept. 1, 2022.
“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,” Johnson said.