To extract more doses per vial, the vaccines are pushing the FDA to loosen up the advice on vaccine handling

President Joe Biden has promised enough covid vaccine to immunize any willing adult by June 1. Right now, however, the gap between supply and demand is so dramatic that vaccines are finding ways to suck the last few drops out of every vaccine bottle – if federal regulators let them do it.

Pharmacists involved in the Covid vaccination campaign say it is common to have half a dose in a Pfizer vial after five or even six doses – and have half a dose left after 10 doses are out taken from a Moderna vial. The combination of two half doses could add thousands to vaccinations if around 2 million doses are given daily in the country.

Therefore, they want to use a single needle to take the rest of the vaccine from two vials from which all full doses have already been taken. The American Society of Health-System Pharmacists asked the Food and Drug Administration to consider granting approval in a recently released letter. The governors of Colorado and Oregon have also asked for permission to allow their pharmacists to bundle Covid vaccine bottles.

However, federal health officials have long spoken out against the reuse of drug vials because of the risk of introducing a bacterial contaminant. From 1998 to 2014, more than 50 outbreaks of viral or bacterial disease were reported as a result of unsafe injection practices, including injecting a drug from the same vial into multiple patients.

The FDA did not want to comment on the pharmacists’ letter, but reiterated its current policy to KHN that “doses must not be pooled from different vaccine bottles, especially for coronavirus vaccines that are not formulated with a preservative.” On their website, the Centers for Disease Control and Prevention specifically urge vaccines to discard vials “when there is not enough vaccine to get a full dose. DO NOT combine the rest of the vaccine from multiple vials to make one dose. “

“It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association for Professionals in Infection Control and Epidemiology. There’s always a small chance that one of the two vials was previously contaminated, which would contaminate a shot that combines their contents, she said. Moderna and Pfizer spokespeople said excess portions of their vaccines should be discarded and never pooled. Johnson & Johnson had no comment on the matter.

Prior to the Covid vaccination program, public health officials generally deprecated the administration of multiple doses of medication from a single vial unless they contained an antibacterial preservative. For example, most childhood vaccines have been shipped and stored in syringes or single-dose vials since 2001 when pharmaceutical companies stopped using a preservative with traces of mercury on some admissions.

Rajesh Gupta, a biologics consultant who set up a sterility testing laboratory at the FDA’s Biologics Evaluation and Research Center from 2006 to 2013 sees little risk in the Covid vaccination process or even in using a single needle to get the Vaccine from two vials to combine.

The Covid vaccines are used so quickly after being removed from the cold store that there is no risk of contamination, he said. “I can safely say that it is scientifically based,” he said, when vaccines gently wipe the rubber stopper on the vial with disinfectant before each intrusion with a syringe.

While their plea for combining vial contents falls on deaf ears with the FDA, pharmacists are already taking many other steps to maximize the yield of mRNA vaccines, which have rather tricky shipping, handling and administration requirements.

Documents leaked through a cyberattack on the European Medicines Agency suggest that Pfizer struggled to ensure the quality of the mRNA in its vaccine. The company responded by saying that all vaccine doses placed on the market were “double-tested to ensure compliance with regulatory specifications”.

Michael Hogue, president of the American Pharmacists Association and dean of Loma Linda University School of Pharmacy in California, runs a clinic at a university high school that has been giving up to 10,000 vaccines a week since Jan 28, giving flu shots in a pharmacy, he said.

“The planning and procedures for these mRNA vaccines [made by Pfizer-BioNTech and Moderna] require tremendous concentration, ”said Hogue. “You have to pay close attention to what’s going on at the moment.”

The Pfizer vaccine, which until recently was always stored in dry ice, is particularly challenging. After the Pfizer vials are removed from a freezer and thawed, saline is injected into each vial. If the syringe preparer does not remove air from the vial after the saline solution is added, the vaccine will shoot out.

After adding the solution, “take the vial between your thumb and forefinger and gently make a rainbow motion ten times to mix the liquids together,” said Hogue. Shaking the vaccine can make it ineffective.

Each Pfizer vaccination contains only one bead of liquid – about 1/16 teaspoon – and pharmacists have to use tiny syringes that allow air bubbles to form. But they can’t tap the syringe to get the bladder out as that too could damage the vaccine, Hogue said.

In order to withdraw six doses from the Pfizer vials, a type of plunger is required that pushes the last trace of the vaccine out of the syringe. But about 15% of the syringes the federal government has shipped to Loma Linda have larger needles that leave a bit of vaccine in the syringe, making it impossible to extract all six doses, he said. That is why Loma Linda bought her own syringes to replace the insufficient ones.

US Pharmacopeia, a not-for-profit agency that publishes standards for the use of medical devices, has released an 11-page guide to the storage, handling, and administration of Covid vaccines. Among other things, it is highly recommended that vaccination sites set up cleanrooms – separate from the areas where vaccines will be administered – to prepare the syringes, said Farah Towfic, director of CEO Operations at USP.

“That way, we don’t have customers breathing on it,” let alone the distraction of greeting old acquaintances gushing with excitement about the vaccination, said Patricia Slattum, a retired professor at Virginia Commonwealth University School of Pharmacy, who said himself A mass vaccination center in Richmond, Virginia volunteered. “There’s a lot of love to walk around there.”

Another technique is to inject each needle in a different location on the rubber vial stopper. Keeping the syringe in the same place over and over can create a large hole that will leak. This tip is especially important as Moderna is currently in discussions with the FDA to hold up to 15 doses of vaccine in each vial, which is 15 punctures of the stopper, noted Anna Legreid Dopp, director of clinical guidelines and quality improvement for the American Society of Pharmacists Health system.

“To create the vaccine, put a needle through the rubber stopper and turn the vial upside down,” Slattum said. “If you put it in the same place, drops will run down the needle. So it is an art not to lose the vaccine. “

Slattum hopes the FDA will consider allowing vaccines to draw the leftover vaccine from two vials. “We who do this work all feel this pressure that our good work is one of the ways we can get out of this pandemic,” said Slattum. “You just don’t want to waste a vaccine!”

This story was produced by KHN publishing the California Healthline, an editorially independent service of the California Health Care Foundation.

Update: Farah Towfic’s job title at USP was incorrect in an earlier version.

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