FAIRFAX COUNTY, Va. — For people who are still struggling to get a COVID vaccine, this news may sound heartbreaking: hospital pharmacists are throwing away thousands of potential doses every day. Current FDA regulations ban pharmacists from pooling what's left in the bottom of a vial to be used again, thus contributing to vaccine waste.
The policy has left Melanie Massiah-White, the chief pharmacist at Inova Health System in tears.
Massiah-White said hospital workers could be vaccinating hundreds more people every day if the FDA would just let them use what they're leaving behind in the bottom of thousands of vials.
"It's like liquid gold," Massiah-White said, describing the vaccine.
She said Inova could use nearly every last drop, if it could implement a common pharmacy practice called pooling, which is sucking up the dribs and drabs from all the vials and mixing them together to create more doses. Massiah-White said hospital pharmacists do this all the time with chemotherapy drugs, intravenous antibiotics, and even flu vaccines.
The FDA said there are six doses in a Pfizer coronavirus vaccine vial. But Massiah-White said when they tested discarded bottles, they found there was half a dose or more left behind.
"With 100 vials, we were able to actually create between 87 and 92 new doses, in three different trials," she said.
Inova has a storage room filled with more than 20,000 spent vials.
"And if you do the math from that, it's literally thousands and thousands of doses that we're throwing away," Massiah-White said.
The FDA has banned pooling because neither Pfizer nor Moderna's vaccines contain preservatives.
"This is an infection control measure," the FDA said in a statement. "Since coronavirus vaccines are formulated without a preservative, it is critical to note that any further remaining product in a vaccine vial that does not constitute a full dose should not be pooled from multiple vials to create one. This is an infection control measure. 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, such as B. cepacia and Serratia liquefaciens, and Serratia marcescens. 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."
Pfizer, which seems to have more residual vaccine left in its vials, sent a statement echoing the FDA:
"On January 5, 2021, the FDA approved an update to the U.S. EUA label for the Pfizer-BioNTech COVID-19 vaccine," Pfizer's statement said. "The updated label states that after dilution, one vial contains six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle, if the amount of vaccine remaining in the vial cannot provide a full dose of 0.3mL, the vial and any excess volume must be discarded. Excess vaccine from multiple vials must never be pooled. Obtaining six doses from the current multi-dose vial by administering with LDS syringes and/or needles can help minimize vaccine wastage and enable the most efficient use of the vaccine.
But Inova's chief pharmacist said it's perfectly safe to use sterile measures to pool vaccine from the same lot.
"I have three kids at home," Massiah-White said. "I would gladly give them a pooled dose."
She's convinced the FDA ban on pooling what's left in the vial is costing American lives, and that allowing pharmacists to combine what's left behind would save lives.