As millions of people across the country line up for their coronavirus vaccines, health officials are struggling to meet growing demand, a result of the supply shortage.
“It’s more valuable than liquid gold, actually,” said Melanie Massiah-White, director of pharmacy at Inova Health System, a nonprofit hospital network based in Northern Virginia.
Some pharmacists say a simple fix could vaccinate thousands more people every week, but the Food and Drug Administration is blocking it.
It’s called “pooling” – and it’s not a new concept. Pharmacists have been doing this for years with everything from flu shots to some chemotherapy drugs to antibiotics. This involves taking what’s left in one vial of medicine and combining it with what’s left in another vial to create a full dose.
“It doesn’t look like much at the bottom of the bottle,” said Dr. Stephen Jones, CEO of Inova Health System, based in Falls Church, Virginia. “But at the end of the day, all in all, that’s a lot of doses that end up wasted, and we’re not allowed to use that extra vaccine. But there are times when there’s almost a full dose to go to. the end of the bottle, which is heartbreaking to let that go to waste. “
Pharmacists in Inova Health, one of the largest hospital systems in the Washington, DC area, say they began to notice significant amounts of vaccine remaining in almost every vial, even after using the additional sixth doses in Pfizer vials. But due to FDA regulations, they are forced to throw away any additional vaccine.
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“It’s heartbreaking for us,” Massiah-White said. “We’ve had several crew members touring here, and at least every day someone says, ‘Why can’t we pool the trash? “”
Inova pharmacists made an experiment by taking 100 vials with residual vaccine. Eighty of them had large sums. Pharmacists found that with the vaccine left in the 80 vials, they could prepare 40 additional full doses. This meant that on a typical immunization day, when the hospital typically gives more than 4,000 vaccines, it could give an additional 400 vaccines with the same supply.
“If we can just start putting them together, using them right away, we’ll increase the amount of vaccine available for free,” Jones said.
Experts say it’s a simple process that pharmacists have been doing for years.
“It’s a common practice that you see in vaccines,” said Stefanie Ferreri, chair of the Practice Advancement and Clinical Education division at the Eshelman School of Pharmacy at the University of North Carolina. . She said only vaccines with the same lot number should be grouped together so clinicians can know where they came from if there are any issues, such as unusual side effects.
Even though pooling is common, 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 the spread. microbial growth in case the vaccine is contaminated with bacteria or other germs.
“This is an infection control measure,” an FDA spokesperson said in a statement. “Cross-contamination of multidose drugs by using the same needle and syringe has occurred with other drugs when this practice was used, causing severe bacterial infections.” If one vial is contaminated, this practice can spread the contamination to others, prolonging the presence of the pathogen and increasing the potential for disease transmission. “
But pharmacy experts say the risk of cross-contamination is low, and the benefits of having more doses far outweigh any risk.
“If this vial is not used right away, the risk of contamination is higher, as there is no preservative in the vial,” Ferreri said. “If the vial is used straight away, with a new vial with the same lot number, then the risk of contamination is extremely low.”
Inova health officials say all doses are used almost immediately in large vaccination clinics like theirs and they already have protocols in place to protect against any kind of cross-contamination.
“We would use these doses within 60 minutes,” Massiah-White said. “They are not going to sit down. They will not reach room temperature. We would be able to get those arm injections very quickly right here in our clinic.
But for now, the vaccination process remains a waiting game as Americans wait for vaccines and vaccine makers ramp up production to meet ever-growing demand.
“At the end of the day, when there are enough vaccines, it doesn’t matter how much wasted,” Jones said. “But right now we are millions of doses missing. So a few more doses from each set of vials will make a difference for hundreds of people a day.”