FBI, FDA investigating alleged vaccine tampering by Aurora employee

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The Federal Bureau of Investigation and Food and Drug Administration are investigating alleged vaccine tampering at a Grafton medical center after an Advocate Aurora Health employee intentionally removed COVID-19 vaccine vials from refrigeration over the weekend.

The Milwaukee- and Downers Grove, Illinois-based health system said the Aurora Medical Center – Grafton employee removed 57 vials of the Moderna vaccine from a pharmacy refrigerator on Dec. 25. The vials, which were left out overnight and equated to more than 500 doses of vaccine, were later discarded.

Once the Moderna vaccine is removed from the refrigerator for administration, it can be kept at room temperature for up to 12 hours, according to the biotechnology company.

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Advocate Aurora said it initially believed the cause was “inadvertent human error,” but the employee on Wednesday acknowledged they intentionally removed the vaccine from refrigeration. The health system did not disclose the employee’s purpose for leaving out the vaccine. The employee was fired.

“We continue to believe that vaccination is our way out of the pandemic,” Advocate Aurora said in a statement Wednesday. “We are more than disappointed that this individual’s actions will result in a delay of more than 500 people receiving their vaccine. This was a violation of our core values, and the individual is no longer employed by us.”

Aurora corporate security informed Grafton Police Department of the alleged vial tampering at 6:18 p.m. Wednesday, according to a police department statement. The FBI, FDA and Grafton Police are investigating the incident.

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Advocate Aurora began vaccinating its frontline employees on Dec. 15. As of Dec. 23, 14,000 employees across its Illinois and Wisconsin facilities had been inoculated.

As of Tuesday afternoon, just over 47,150 COVID-19 vaccines have been administered in Wisconsin of the 156,875 doses that have been shipped to the state.

Tuesday saw the second-highest number of vaccines administered (6,427) in the two weeks since Wisconsin health care organizations began inoculating frontline workers. The peak up to Tuesday was Dec. 23, when 9,313 vaccines were administered in the state.

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Of the 47,157 administered vaccines as of Tuesday, 40,850 were produced by Pfizer and 6,306 were from Moderna.

State health officials have said administration of the vaccine will ramp up significantly in the coming weeks, but attributed initial delays to the challenges of rolling out a brand new vaccine.

“When we got those first doses a week ago, the ink was barely dry on the paper of what the appropriate use of this vaccine was, around solidifying all of the storage requirements,” Julie Willems Van Dijk, deputy secretary for the Wisconsin Department of Health Services, said during a Dec. 21 call with reporters. “… That is not how we usually bring a new medication or a new vaccine into the world, that we start administering it within 48 hours of its approval. There’s a period of time for people to learn about it to understand its implications.

“I can assure you, you are very quickly going to see rising numbers of vaccination,” she added. “But the intent was never that we would be able to give 49,000 doses in the first week. It was that we would have those doses available so that people know they can plan to give them in the subsequent days.”

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