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Governors of Colorado, Oregon ask FDA to approve COVID-19 vaccine pooling

Pharmacists say pooling would allow them to mix vaccine leftovers from different vials. The FDA has not approved this practice for COVID-19 vaccines.

COLORADO, USA — Governor Jared Polis (D-Colorado) said there is a way to avoid COVID-19 vaccine waste and get a lot more out of the state's current supply.

But first, the Food and Drug Administration (FDA) has to sign off on it.

It's called vaccine pooling - basically combining leftovers from different vials of the same type of vaccine. State leaders and pharmacists say it is common practice with medications and they’d like to see the FDA approve the practice for COVID-19 vaccines.

On Tuesday, Polis and the Governor of Oregon, Kate Brown, sent a letter to FDA leadership asking for a short-term emergency waiver permitting experienced practitioners to pool COVID vaccines.

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In the letter, the governors argue the benefits outweigh potential risks and reduce waste. They wrote: “We could increase available vaccines by as much as 10% until additional vaccines can be produced.”

Currently, the FDA advises vaccine administrators not to pool vaccines, citing contamination and infection risks.

The Pfizer and Moderna vaccines do not contain preservatives, and the FDA said they are concerned about the risk of cross-contamination when using the same needle in multiple vials.

Wednesday evening, a spokesperson for Governor Polis said the FDA had not yet responded to his letter.

COVIDo19 vaccine pooling is a topic of conversation among pharmacists, who often draw vaccines from the vials to prepare the shots for distribution.

“Right now… we’re able to get the [extra] 6th dose in the Pfizer vial, sometimes able to get that [extra] 11th dose out of Moderna. But even after you get those doses, there’s still some medication left in the vials,” said Dr. Melissa Miller, Director of Pharmacy at North Suburban Medical Center in Thornton. “You’re looking at ‘liquid gold,’ essentially, something that is priceless. To say, well, I’m going to throw it out even though I know there is enough extra there to get additional doses is just so hard.”

Credit: KUSA
Dr. Melissa Miller, Director of Pharmacy at North Suburban Medical Center, draws up doses of the COVID19 vaccine

Miller said pooling is a pretty common practice already.

“When we’re making an IV for a patient in the hospital and we’re drawing up medication, we’re not only using one vial. Most medications require anywhere from one to three vials worth of medicine,” she explained. “So you’re using several different vials to make the dose you need.”

Governor Polis said the flu shot is another vaccine commonly pooled.

Miller said if pooling were approved for the COVID-19 vaccine, it would be safest to pool within the same lot or “batch” of the vaccine.

“Because if there should be an issue at any point with that vaccine, it’s important to be able to trace it back to a lot number," she explained. "And we can trace it to which patients got that vaccine and it’s important to be able to know, ok, this is the issue we’re looking at? And follow through the safety process with it."

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Miller said pharmacists are eager to avoid wasting the COVID-19 vaccine, but they’re also eager for data to prove pooling is a safe solution. While drawing COVID-19 vaccines for a clinic outsider at her hospital Wednesday, Miller demonstrated the multiple steps to preparing a shot.

Those steps include wiping the vial with an alcohol wipe to sanitize the top between each draw of a new dose using a new syringe.

Credit: KUSA
Dr. Melissa Miller, Director of Pharmacy at North Suburban Medical Center, draws up doses of the COVID19 vaccine

“It’s important to take the steps to make sure we’re doing it right, to make sure it safe, and to make sure we have a good answer," she said. "We don’t want to jump to any conclusions and have them be the wrong conclusion. And that’s where getting the FDA to weigh in, seeing – is there study data available? Can we get study data if there’s not? Let’s do it ourselves. And figure those questions out. Having that information is really important."

If the FDA did change its guidance to allow pooling of the COVID-19 vaccine, Miller said she is eager to give any extra doses possible.

“In a small clinic, where you’re maybe doing 350 doses in a day, you’re looking at between 30-50 additional doses that you’d be able to get,” she said. “When you compound that over multiple days a week and multiple clinics, I mean…  it adds up to thousands and thousands of extra doses.”

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