The Tennessee Department of Health examined the cold chain for COVID-19 doses given between Dec. 28 and Feb. 24 here and found no disruption that would harm the doses, according Dr. Lisa Piercey, health commissioner.

State Health Dept.: Early data shows vaccines ‘kept in temperature’

“Because of the exhaustive assessment by local, state, federal and industry partners, we can confidently reassure all recipients of vaccine at Shelby County sites that the doses they received were stable and effective,” Piercey said in a media briefing Monday afternoon, March 15.

In all, state and federal agencies looked at processes that affected nearly 55,000 doses, a “Herculean” task, Piercey said, which took an estimated 1,000 public sector manpower hours over the last 25 days.

“Due to the previously described deficiencies in record keeping, this was an extensive and painstaking analysis. Information was gathered from vaccine storage units, digital data loggers, all available handwritten temperature logs and hours of personnel interviews between TDH (Tennessee Department of Health) and CDC (Centers for Disease Control),” Piercey said.

The work also included analysis by scientific teams from Pfizer and Moderna and consultation with U.S. Department of Health and Human Services. The White House was notified of the lapses, Piercey said, which included wasting 2,510 doses of vaccine in seven incidents.

The CDC’s final report on the investigation issue was delivered to Shelby County government officials early Monday. The state report on what the county needs to do to improve its accountability is expected in several weeks.

In a statement Monday afternoon, Shelby County Mayor Lee Harris confirmed that the CDC had finished it review and found that the storage temperature had been properly maintained.

“We are pleased that the CDC’s findings validate what we believed all along,” Harris said.

While the CDC has signed off on the stability of COVID vaccine given in Shelby County in the timeframe in question, the federal agency was clear, Piercey said, that it is still looking into other issues that surfaced in the investigation, including how records are kept and inventory is managed for other vaccines commonly given by the Health Department.

In the meantime, Shelby County is not administering any vaccines. 

The CDC team left late last week. The state Health Department wrapped up its work in the investigation Monday.

The outcome was an “enormous relief,” Piercey said, for everyone involved in the investigation.

“The very worst thing that we could imagine is having to deal with the possibility that the people who got the doses didn’t receive stable and effective doses. And because of the issues with recordkeeping, that process of analysis took a lot longer than we expected it to, but it was critically important,” she said.

“It was incredibly important to know that Shelby County has got effective doses. We would do that for anywhere in Tennessee, but specifically in Shelby County. It’s a huge population center with a lot of vulnerable individuals. It was well worth every hour.”

It is not clear if or when Shelby County Health Department will be allowed to resume custody of the COVID-19 vaccine or what it would have to do to prove itself capable.

“I think that would definitely require a lot of conversation with both the Department of Health, as well as the City of Memphis, Shelby County Health Department and all of the other partners involved,” Piercey said. “Determining how they want to be involved – whether that’s partially or fully – that’s something that’s going to take a lot of conversation.”

So far, she said, the department has indicated an interest in giving the shots through state-funded teams that deliver it in hard-to-reach areas or involving its nurses in the current program, which the City of Memphis has been running since late February.

Piercey praised city leadership for “stepping up to the plate and making sure that this process went on without a hitch.” The transition was smooth, she said, and noted the city is “in a really routine cadence of giving well in excess of over 30,000 doses a week.”

“That’s exactly what we want to see in Shelby County,” she said. “Shelby Countians can have full reassurance that the does they are getting are fully effective and safe.”

Piercey said Mayor Harris last week provided her with documentation that local law enforcement had looked into allegations that 12 doses had been stolen.

In late February, Shelby County Health Department said the issue was turned over to local law enforcement to investigate. They found insufficient evidence to file a report of unlawful activity.

There were no witnesses to the alleged theft.

On Monday, Piercey said she also knew little of the incident involving children being vaccinated.

“I believe there were attempts made at the time to contact them, but they were unsuccessful. This was a part of one of those very large mass events. And I’m not sure that they will ever be identified,” she said.

The Appling City Cove vaccination site is run by the University Clinical Health and the City of Memphis.

“We do know who the children are,” said Dr. Jon McCullers, senior executive associate dean of Clinical Affairs and chief operating officer of the College of Medicine at University of Tennessee Health Science Center. 

“We did contact them after this came to light and made sure they had done fine, and they did indeed do absolutely fine with the vaccine with no side effects. Dr. Piercey is with the state Department of Health and this is not a Health Department-run site. She probably is just not aware of the details,” McCullers said.

Monday was Shelby County Health Department Director Alisa Haushalter’s last day of work. She announced her resignation Feb. 26 when the state announced the number of expired doses was some 1,200 more than the 1,300 Haushalter reported being wasted in mid-February.

When asked about Haushalter’s performance, Piercey described her as a “humble public servant” who had dedicated “three if not four decades of her career to public service.”

“Shelby County should be grateful, and I’m grateful for the service that she’s given. I regret that it had to turn out this way, but she has been nothing but the consummate professional, and she’s to be credited for that. And I wish her all the best in her next endeavors.”