While millions of people across the country queue for coronavirus vaccines, health officials are struggling to meet the growing demand resulting from a lack of supplies.
“It’s more valuable than liquid gold, truth be told,” said Melanie Massiah-White, director of pharmacy at Inova Health System, a chain of non-profit hospitals based in North Virginia.
Some pharmacists say a simple solution could vaccinate thousands of people each week, but the Food and Drug Administration is getting in the way.
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 and antibiotics. It involves taking what’s left of a drug bottle and combining it with what’s left in another bottle 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 ultimately, in total, this adds up to many doses that end up being wasted, and we are not allowed to use this additional vaccine. But there are times when there is almost a full dose at the end of the bottle, which is painful let that go to waste. “
Pharmacists at Inova Health, one of the largest hospital systems in the Washington, DC area, say they have begun to notice significant amounts of leftover vaccine in almost all bottles, even after using the sixth additional doses in Pfizer bottles. But because of FDA regulations, they are being forced to discard any extra vaccines.
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“It is painful for us,” said Massiah-White. “We had several members of the team moving around here, and at least daily, someone says, ‘Why can’t we collect the trash?'”
Inova pharmacists did an experiment, taking 100 vials that contained residual vaccine. Eighty of them were left with significant amounts. Pharmacists found that with the vaccine left in the 80 vials, they could make an additional 40 full doses. This means that on a typical vaccination day, when the hospital normally delivers more than 4,000 injections, it could deliver another 400 vaccination injections with the same supply.
“If we can just start putting them together, using them immediately, we will increase the amount of vaccines available for free,” said Jones.
Experts say it is a simple process that pharmacists have been doing for years.
“This is a common practice that you see in vaccines,” said Stefanie Ferreri, president of the advance practice and clinical education division at the University of North Carolina’s Eshelman School of Pharmacy. She said that only vaccines from the same batch should be grouped together so that doctors can track where they came from if there were any problems, such as unusual side effects.
Although pooling is common, the FDA says that pharmacists and other doctors cannot collect the leftovers of the Covid-19 vaccine because neither Moderna nor Pfizer products contain preservatives, which help to stop microbial growth in case the vaccine is contaminated with bacteria or other germs.
“This is an infection control measure,” an FDA spokesman said in a statement. “Cross-contamination of multidose drugs using the same needle and syringe occurred with other drugs when this practice was used, causing serious bacterial infections. If a bottle 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 that the benefits of taking more doses far outweigh any risk.
“If that bottle is not used immediately, the risk of contamination is greater, because no preservatives are contained in the bottle,” said Ferreri. “If the bottle is used immediately, with a new bottle with the same batch number, the risk of contamination is extremely low.”
Inova health officials say that all doses are used almost immediately in large vaccination clinics like theirs and that they already have protocols for protection against any type of cross-contamination.
“We would use these doses in 60 minutes,” said Massiah-White. “They are not going to sit down. They are not going to get to room temperature. We could very quickly put these injections into the guns right here in our clinic.”
But for now, the vaccination process remains a waiting game, while Americans wait for injections and vaccine manufacturers to increase production to meet ever-increasing demand.
“Ultimately, when there are enough vaccines, wasting some at the bottom doesn’t matter,” said Jones. “But now, millions of doses are missing. So a few extra doses of each set of bottles will make a difference to literally hundreds of people a day.”