As millions of Americans across the country line up to receive the Covid-19 vaccine, health officials are still struggling to meet growing demand, a result of shortages in supplies.
“It’s more valuable than liquid gold, to tell the truth,” said Melanie Massiah-White, director of pharmacy for Inova Health System, a nonprofit network of hospitals based in Northern Virginia.
Some pharmacists say there is a simple solution that could get thousands more people vaccinated each week, but the Food and Drug Administration is getting in the way.
It’s called “bundling” and it’s not a new concept. Pharmacists have been doing it for years with everything from the flu shot to some chemotherapy drugs and antibiotics. It involves taking what’s left in one bottle of medicine and combining it with what’s left in another bottle to create a full dose.
“It doesn’t seem like much at the bottom of the bottle,” said Dr. Stephen Jones, CEO of Inova Health System, based in Falls Church, Virginia. “But ultimately, put together, that ends up in a lot of wasted doses and we are not allowed to use that extra vaccine. But there are times when there’s almost a full dose at the end of the vial, which is heartbreaking to let it go to waste. “
Pharmacists at Inova Health, one of the largest hospital systems in the Washington, DC 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 due to FDA regulations, they are now forced to scrap any additional vaccines.
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“It’s heartbreaking for us,” Massiah-White said. “We’ve had several team members rotate around here and at least on a daily basis someone says, ‘Why can’t we collect the waste?'”
Inova pharmacists did an experiment, taking 100 vials that had residual vaccine. Of these, 80 of them had significant amounts left over. Pharmacists found that if the vaccine was left in those 80 vials, they could produce an additional 40 full doses. That meant that on a typical vaccination day, when that hospital will typically administer more than 4,000 injections, they could administer an additional 400 vaccines with the same supply.
“If we can just start putting them together, using them right away, we will increase the number of vaccines available for free,” Jones said.
Experts say it’s a simple process that pharmacists have been doing for years.
If one vial becomes contaminated, this practice can spread the contamination to others, prolonging the presence of the pathogen and increasing the potential for disease transmission.
“That’s a common practice seen in vaccines,” said Stefanie Ferreri, president of the Advancement of Clinical Practice and Education division at the University of North Carolina Eshelman College of Pharmacy. He said only vaccines from the same batch number should be combined, so doctors can track where they came from in case there are any problems, such as an unusual side effect.
Although combining is common practice, the FDA says that pharmacists and other physicians cannot combine the leftover Covid-19 vaccine because neither Moderna’s nor Pfizer’s products contain preservatives, which help stop microbial growth in the event that 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 using the same needle and syringe has occurred with other medications when this practice was used, leading to serious bacterial infections. If one vial becomes 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 danger of cross contamination is low and the benefits of having more doses of the Covid vaccine far outweigh any risks.
“If that vial is not used immediately, then the risk of contamination is higher because there is no preservative in the vial,” Ferreri said. “If the vial is used immediately, with a new vial with the same lot number, the risk of contamination is extremely low.”
Inova health officials say that in large vaccination clinics like theirs, all doses are used almost immediately and they already have protocols in place to protect against any kind of cross contamination.
“We would use those doses in 60 minutes,” Massiah-White said. “They are not going to sit. They will not reach room temperature. We could get our hands on those vaccines very quickly right here in our clinic. “
But for now, the vaccination process remains a waiting game, as Americans wait their turn to receive the injection and for vaccine manufacturers to ramp up production to meet ever-increasing demand.
“Ultimately, when there are enough vaccines, wasting some at the bottom will not matter,” Jones said. “But right now, we are missing millions of doses. So a few extra doses from each set of vials will make a difference for literally hundreds of people a day. “