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North Dakota auditor: COVID vaccines may have been stored at wrong temperature; health officials deny

State Auditor Josh Gallion said the report released by his office reveals a mix of mistakes in vaccine storage and inconsistent record-keeping.

COVID-19 VACCINE
A vial of COVID-19 vaccine.
Forum file photo
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BISMARCK — An audit of the North Dakota Department of Health alleged that thousands of COVID-19 vaccine doses administered last year could have been stored at incorrect temperatures, potentially diminishing the jabs' effectiveness.

The health department maintains it kept vaccines at the right temperatures, and record-keeping issues gave auditors the false impression that doses were stored under the wrong conditions.

State Auditor Josh Gallion said the report released by his office on Tuesday, Oct. 18, reveals a mix of mistakes in vaccine storage and inconsistent record-keeping.

The report says health department inventory records indicated that 1,455 doses of the Moderna vaccine were administered in North Dakota prior to June 2021 after possibly being stored at too cold of a temperature. The COVID-19 vaccine became publicly available in December 2020.

Each of the brands of the COVID-19 vaccine require different storage temperatures, and holding the vaccines in the wrong conditions can render them ineffective, leaving recipients unprotected against the virus, the audit notes. Moderna vaccines should be stored in freezers but not ultra-cold conditions below -50 Celsius, according to the manufacturer.

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The health department, which recently merged with the state Department of Human Services, said in the audit that no Moderna vaccines were ever actually held in ultra-cold freezers. The agency contends that a clerical error recorded the doses as having been stored in the wrong freezers. Health officials determined it was not necessary to notify recipients of the 1,455 doses because of the record-keeping error.

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“We did not distribute non-viable vaccines," said Health Response chief Tim Wiedrich. “The vaccine was appropriately stored at the right temperatures and during the distribution process that was maintained. What we could not do is come back and show the level of detail (the auditor was looking for)... That was a documentation issue. We admit we did not meet the auditor's expectations for documentation.”

gallion.jpg
North Dakota State Auditor Josh Gallion speaks at a press conference on Wednesday, Aug. 17, 2022, in Bismarck.
Jeremy Turley / Forum News Service

Gallion's report said the health department did not provide any evidence of a clerical error and the auditors "cannot determine if the cause of these findings is related to record-keeping errors... or if it was because of actual improper storage of the COVID-19 vaccines."

The Republican auditor noted that members of his office inspected the state warehouse's inventory in August 2021 and found several discrepancies between the health department's records and the physical location and count of vaccine doses.

A second finding in the audit alleged that doses were administered after being held in the fridge too long.

Once Moderna vaccines are taken out of the freezer, they can be stored in fridges for up to 30 days. Gallion's audit found that between 457 and 701 Moderna doses were administered beyond the recommended 30-day fridge shelf life.

Wiedrich rejected the finding, saying department staffers write expiration dates for doses on the vial caps, and no doses were administered past the recommended shelf life.

Gallion's report also found that temperature readings were missing for an ultra-cold freezer that supposedly held about 12,800 doses of the Pfizer vaccine, making it impossible to verify whether the vaccines were stored at the right temperature.

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The health department says an error in the inventory recording system is to blame, and that the ultra-cold freezer in question was not used for vaccine storage.

Wiedrich said North Dakotans who received COVID-19 vaccines from the department can call 866-207-2880 if they have any concerns, though he maintained that the agency did not administer any vaccines that were held at incorrect temperatures. Weidrich added that the agency has since shored up its record-keeping to prevent any questions about vaccine storage in the future.

Gallion said he recognizes the extreme logistical challenges the health department faced during the pandemic, but he believes there's always room for improvement.

“From the auditor’s office perspective, we come in afterwards, and we try to help people understand what occurred with the hopes that we can learn … so that if it happens again, next time we can be better prepared," he said.

doh_audit by Jeremy Turley on Scribd

Jeremy Turley is a Bismarck-based reporter for Forum News Service, which provides news coverage to publications owned by Forum Communications Company.
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