• January 19, 2021

Advocate Aurora Health defends COVID-19 vaccine security after ‘bad actor’ spoils doses

Jan 1, 2021

Advocate Aurora Health officials said Thursday they are still confident in the system’s security protocols despite an employee intentionally removing 570 doses of coronavirus vaccine from refrigerated storage over the weekend, saying the act was the result of a “bad actor” and not “bad processes.”

A pharmacist at Aurora Medical Center-Grafton in Wisconsin admitted to removing 57 vials, which each containing approximately 10 doses of the Moderna vaccine, from freezers at least twice between Dec. 24 and Dec. 26. The employee, who has not yet been identified, returned the vials into storage each time and has been fired. Local and federal authorities are investigating the incident.

A pharmacy technician found the vials outside of refrigerated storage on the morning of Dec. 26.

Some of those doses were used to vaccinate 57 front-line healthcare workers on Dec. 27. Aurora Health Care Medical Group President Dr. Jeff Bahr said those workers have been notified that the incidents may have spoiled their doses.

The discarded vials will likely delay vaccination for hundreds of people. Bahr said the health system would coordinate with Moderna and the Food and Drug Administration on a plan to re-vaccinate the 57 individuals given the spoiled doses.

“At this time there is no evidence that the vaccinations pose any harm to them other than being potentially less effective or ineffective,” Bahr said. “There is no evidence that the individual in question tampered with the vaccine in any way other than removing it from refrigeration.”

Bahr could not provide information as to a possible motive for why the pharmacist removed the vials from refrigerated storage. Unlike the vaccine produced by Pfizer and BioNTech, which requires special storage freezers that can reach temperatures of minus 70 degrees Celsius, the Moderna vaccine can be stored in many regular freezers.

Bahr said an internal review of the incident found no significant security gaps that would warrant making changes to their current protocols.

“We feel strongly that our processes are sound,” Bahr said. “This fell more to this being a bad actor involved than a bad process.”

But the incident raises security questions over the storage of coronavirus vaccine at health facilities. Like Advocate Aurora, other hospital systems have put in place security measures as part of their preparation to distribute the vaccine.

Charles Jolie, a spokesman for Rush University Health System in Chicago, said they had no plans to re-evaluate their security protocols, expressing confidence that the systems they have developed to safely store and distribute the vaccine remain effective.

“We’ve not encountered any issues and have developed a system that gives us great confidence as we continue to be a partner in vaccine distribution,” Jolie said.

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