As millions of Americans across the country line up for their shot at getting the Covid-19 vaccine, health officials are still struggling to meet the surging demand, the result of short supplies.
“It’s more valuable than liquid gold, truth be told,” said Melanie Massiah-White, chief pharmacy officer for Inova Health System, a nonprofit hospital network based in Northern Virginia.
Some pharmacists say there’s a simple solution that could get thousands more people vaccinated each week, but the Food and Drug Administration is standing in the way.
It’s called “pooling” — and it’s not a new concept. Pharmacists have been doing it for years with everything from flu vaccine to some chemotherapy medications to antibiotics. It involves taking what’s leftover in a drug vial and combining it with what’s left in another vial to create a full dose.
“It doesn’t look like a lot at the bottom of the bottle,” said Dr. Stephen Jones, CEO of Inova Health System, based in Falls Church, Virginia. “But ultimately in aggregate, that ends up to a lot of doses that end up being wasted, and we’re not allowed to use that additional vaccine. But there are times where there’s almost a full dose at the end of the vial, which is heartbreaking to let that go to waste.”
Pharmacists at Inova Health, one of the largest hospital systems in the Washington, D.C., area, say they started noticing significant amounts of leftover vaccine in almost every vial, even after using the additional sixth dose in Pfizer’s vaccine. But because of the FDA’s regulations, they are now being forced to throw out any extra vaccine.
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“It’s heartbreaking for us,” said Massiah-White. “We’ve had multiple team members that rotate through here and at least daily somebody says, ‘Why can’t we pool the waste?’"
The Inova pharmacists did an experiment, taking 100 vials that had residual vaccine. Of those, 80 of them had significant amounts left over. The pharmacists found that with the vaccine left in those 80 vials, they could make 40 additional full doses. That meant on a typical vaccination day, when that hospital will typically give more than 4,000 shots, they could give an additional 400 vaccines with the same supply.
“If we can simply start putting them together, using them immediately, we’ll increase the amount of vaccines available for free,” Jones said.
Experts say that it’s a simple process that pharmacists have been doing for years.
If one vial becomes contaminated, this practice can spread contamination to the others, prolonging presence of the pathogen and increasing the potential for disease transmission.
“That is a common practice that you see in vaccines,” said Stefanie Ferreri, chair of the division of practice advancement and clinical education at the University of North Carolina’s Eshelman School of Pharmacy. She said only vaccines from the same lot number should be pooled, so that clinicians can track where it came from in the event there are any issues, like an unusual side effect.
Even though pooling is common practice, the FDA says pharmacists and other clinicians cannot pool leftover Covid-19 vaccine because neither Moderna nor Pfizer’s products contain preservatives, which help stop microbial growth in case the vaccine is contaminated with bacteria or other germs.
“This is an infection control measure,” an FDA spokeswoman told NBC News in a statement. “Cross-contamination of multidose medications through the use of the same needle and syringe has occurred with other medications when this practice was utilized, causing serious bacterial infections. If one vial becomes contaminated, this practice can spread contamination to the others, prolonging presence of the pathogen and increasing the potential for disease transmission.”
But pharmacy experts say that the danger of cross contamination is low and that the benefits of having more doses of the Covid vaccine far outweigh any risk.
“If that vial is not used right away, then the risk of contamination is higher because no preservative is contained in the vial,” Ferreri said. “If the vial is used right away, with a new vial with the same lot number, then the risk of contamination is extremely low.”
Inova health officials say that at large vaccination clinics like theirs, all doses are used almost immediately, and they already have protocols in place to protect against any type of cross contamination.
“We would use those doses within 60 minutes,” said Massiah-White. “They’re not going to sit. They’re not going to come to room temperature. We would be able to very quickly get those shots into arms right here in our clinic.”
But for now, the vaccination process remains a waiting game, as Americans wait their turn for the shot and for vaccine makers to step up production to meet the ever-growing demand.
“Ultimately, when there are enough vaccines, wasting some at the bottom won't matter,” Jones said. “But right now, we are millions of doses short. So a few extra doses from each set of vials will make a difference in literally hundreds of people a day.”
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