An error involving the temperature of COVID vaccines is causing Walgreens to look into its procedures and requiring patients in five Northeast Ohio nursing homes to be revaccinated.
Walgreens on Tuesday notified Ohio Gov. Mike DeWine that vials of COVID-19 vaccine administered to patients in five nursing homes Monday were not stored at the proper temperature.
In a statement, Walgreens said, "After completing vaccinations on Feb. 1 at five long-term care facilities in Ohio and following our internal controls processes, we discovered the vials containing the vaccine were subject to improper storage before being delivered to these facilities. There is no reason to believe any patients who received these doses will suffer any harm."
Walgreens is working with the affected facilities—Ashtabula County Residential Services Corp "The Maples" in Kingsville; Ashtabula Towers in Ashtabula; Heather Hill Care Communities in Chardon; Six Chimneys in Cleveland; and Willow Park Convalescent Home in Cleveland—and is following CDC and manufacturer guidance on how and when to revaccinate patients.
During a Tuesday press conference, DeWine said that there will be "a lapse of time before that next shot takes place. There's some, prescribed by the manufacturer, lapse of time before that dose is given again."
"We're going to have to simply wait, I think, to see what guidance they receive from the CDC and manufacturer on next steps," Ohio Department of Health Chief Medical Officer Dr. Bruce Vanderhoff said during the Tuesday press conference.
It is unclear which vaccine was administered in the affected facilities but both the Pfizer-BioNTech and the Moderna vaccines need to be kept at very cold temperatures.
"Walgreens is investigating and has taken additional immediate steps to review and correct our operating procedures to prevent this from occurring again," the company said in a prepared statement.
Vanderhoff said the vaccines can be "challenging to handle because they require ultra-cold storage until they're ready to be administered."
"If there is any breach in that cold storage process before the vaccine is thawed and then administered to patients, the vaccine can't be relied upon to be effective, to work as designed," Vanderhoff said. "This is really an issue about taking every step that we can to ensure that whenever a person gets a vaccine, they're getting a vaccine that will work."
The Ohio officials said that not every person who received a vaccine in the nursing homes in question received one of the affected doses.
"The lot of this vaccine that was compromised was not the only shots that were administered. Somebody could have been in that nursing home and gotten it from a different lot," DeWine said. "We're assured by Walgreens that they know who got what lot."
The Star Beacon reported that 24 residents and staff at The Maples received doses of the affected vaccine.
Walgreens is part of the federal Pharmacy Partnership for Long-Term Care Program, which pairs long-term care facilities with either Walgreens or CVS for vaccine administration.
As of Wednesday, 3,299,953 people in long-term care facilities have received the first dose of a COVID-19 vaccine and 707,243 people have received the second dose, according to the CDC.
In Ohio, the first dose of a COVID-vaccine has been administered in all of the 920 skilled nursing facilities in the state, and the second dose has been given in 89% of facilities, according to the state and the second dose in 89% of snfs, the state said Tuesday. Ohio has administered first doses in 86% of its 645 assisted living facilities and second doses in 48% of those facilities.
A spokesperson for CVS said the company has not been asked to repeat any vaccinations in long-term care facilities.
The American Health Care Association/National Center for Assisted Living, which represents more than 14,000 long-term care providers, and LeadingAge, which represents more than 5,000 aging services providers, both said they have not heard of revaccination being necessary elsewhere.
"Overall, though, we've heard of very real variations on vaccine rollout and distribution, state-by-state. This confusion is the result of the current patchwork approach – no federal leadership and coordination; instead, we've got state-by-state, region-by-region and even clinic-by-clinic variation," said Lisa Sanders, a LeadingAge spokesperson.