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State Senate’s only physician questions Maryland health secretary over delay alerting patients of possibly spoiled vaccines

The state Senate’s sole physician pressed the head of the state health department Wednesday over a monthslong delay in notifying patients who may have received spoiled vaccines — and said he is worried issues are prevalent among other vaccine providers.

Democratic Sen. Clarence Lam asked Maryland Department of Health Secretary Dennis R. Schrader about the department’s failure to quickly notify hundreds of Marylanders who may have received vaccines that were mishandled — potentially rendering them ineffective — by TrueCare24, a San Francisco-based company the state contracted with last year to hold vaccine clinics across Maryland.

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Schrader said agency auditors are reviewing the issue during the exchange which came during an online meeting of the General Assembly’s vaccine oversight work group.

The health department estimates 476 people need to be revaccinated as a result of the mishandled vaccines. The department began notifying patients Dec. 30, Schrader said.

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A whistleblower within the department, Jessicah Ray, reported to the department’s inspector general that health officials were aware that potentially hundreds of vaccine doses were rendered ineffective by improper storage but were not alerting patients. The state took months to ask for guidance from the U.S. Centers for Disease Control and Prevention on whether to contact those TrueCare had vaccinated — more than a quarter of whom were incarcerated.

Ray estimated that at least 1,000 doses are in question.

TrueCare administered vaccines from the end of July through September at more than 100 sites across the state, including prisons, courthouses and grocery stores. Despite issues with TrueCare from its first day July 17 — its sites lacked medical equipment and couldn’t produce training certifications for staff members, Ray wrote in her complaint to the inspector general — the state put it on a remediation plan and allowed the company to resume administering vaccines beginning July 30.

It wasn’t until Sept. 3 that a health department manager ordered TrueCare to halt vaccinations after another health department employee reported the vendor was storing vaccine in hotels and cars, emails show. Officials then began trying to gather information from TrueCare to prove vaccine viability; the company provided records for only a fraction of its clinics, Ray said.

The Baltimore Sun first reported Ray’s complaint last week. TrueCare has not responded to multiple phone calls and emails requesting an interview.

The department referred the matter to health department’s audit department Sept. 24; auditors are still investigating, Schrader said.

Schrader said the department reached out Nov. 10 to the CDC about TrueCare; the federal agency advised the department to seek to revaccinate people with one dose immediately, regardless of the total number of doses they’ve received.

More than a month later the department has begun calling patients and expects to reach them all by the end of this week, Schrader said.

“To be sure I am not happy about how long it’s taken to obtain the clinical next steps,” Schrader said. “I’ve directed the audit team to complete their review and have it on my desk no later than the end of this month.”

But Lam, who represents Howard and Baltimore counties, said he was concerned that TrueCare is not an outlier, and that he’s heard other third-party vaccine vendors “may also have quality control issues in handling the vaccine.”

“My concern is that this is not just a problem with TrueCare; that there may be more systemic problems in place here with other vendors administering vaccine,” Lam said. “That TrueCare may only be the tip of the iceberg that the public has heard about and that the press has caught onto.”

Lam criticized the department’s pay-per-shot contract model, where vendors were compensated for each shot administered, and which Lam said contributed to potential quality control issues.

“It seems like at the department there’s just a blind drive toward just hitting numbers, to getting as many people vaccinated as possible regardless … to the risk of safety.”

Schrader responded that the department “recognized very quickly that [the pay-per-shot] model wasn’t going to work” when the state piloted it in the spring. TrueCare’s contract, which was pay-per-shot, was executed in June.

“We found out we weren’t satisfied with that approach,” Schrader said.

The department brought on new vaccine vendors when it rebid the contracts for a flat fee that started around August, Schrader said.

“So it didn’t matter how many shots they gave, we paid them a flat rate and there was no incentive to cut corners,” he said. “That has worked much, much better.”

Baltimore Sun reporters Hallie Miller and Meredith Cohn contributed to this article.

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