President Joe Biden has promised enough covid vaccine to give all willing adults the vaccine by June 1. But right now, the gap between supply and demand is so staggering that vaccines are getting -out ways to remove the final levels from each vaccine vial – if federal regulators allow them.
Pharmacists involved in the covid vaccine campaign say it is common for half a dose to be left in a Pfizer vial after five or even six doses – and for half a dose to be left after 10 doses. pulled out of Moderna’s vial. Combining two half-doses could increase vaccination by thousands at a time when two million or so doses are being given daily in the country.
Therefore, they want to use one hypodermic needle to withdraw a leftover vaccine from two vaccines since the whole doses have already been removed. The American Association of Health System Pharmacists asked Food and Drug Administration to consider granting permission to do so in a recent letter. The regulators of Colorado and Oregon have also sought permission to allow their pharmacists to combine covid vaccine filters.
Federal health regulators, however, have long opposed the reuse of drug filters because of the risk of introducing bacterial contamination. From 1998 to 2014 more than 50 outbreaks of viral or bacterial infection were reported as a result of unsafe injection practices, including injecting several patients with a drug from the same vial.
The FDA would not comment on the pharmacists’ letter but told KHN the current policy “that doses of various vaccine viruses, especially for coronavirus vaccines, which are not compounded, should not be combined. -keeping. “On their website, the Centers for Disease Control and Prevention clearly tells vaccines to eradicate viruses” when there is not enough vaccine to get a full dose. DO NOT put the remaining vaccine from multiple filters to get a dose. “
“It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association of Professionals in Disease Control and Epidemiology. There is always a small chance that one of the two teeth has been previously contaminated, which would contaminate a bullet that would bring their contents together, she said. Spokespeople for both Moderna and Pfizer said too many doses of their vaccines must be discontinued and not taken together. Johnson & Johnson had no opinion on the matter.
Prior to the covid vaccination program, public health officials generally complained that they took several doses of patients from a single vial, if there was no antibacterial protective agent. Most childhood vaccines, for example, have been administered and stored in single – dose filters or filters since 2001, when drug companies stopped using preservatives that contain mercury traces in some cases. of pictures.
Rajesh Gupta, a biology consultant who set up a sterility laboratory while attending the FDA’s Center for Biology Assessment and Research from 2006 to 2013, sees little risk in the covid vaccination process, or even in it. using one needle to combine vaccines from two. vials.
The covid vaccines are used so soon after their removal from cold storage that there is no risk of contamination, he said. “I can say with a degree of confidence that it is scientifically strong,” if vaccines carefully wipe the rubber stopper at the top of the vial with a disinfectant before each syringe entry, he said.
While the FDA’s claim to combine vial content may fall on deaf ears, pharmacists are already taking many more steps to get the most out of the mRNA vaccines, which have behavioral, treatment requirements. and very finicky administration.
Documents released via cyberattack on the European drug regulatory body suggest that Pfizer had difficulty determining the quality of the mRNA in its vaccine. The company said in response that every vaccine dose it placed on the market was “double-tested to ensure compliance” with regulatory specifications.
Michael Hogue, president of the Association of American Pharmacists and dean of the Loma Linda University School of Pharmacy in California, will run a clinic at a university gym that has been administering up to 10,000 vaccines per week since Jan. 28 Mr Shortridge: It ‘s not nearly as simple as managing pictures of the flu at a pharmacy, he said.
“Design and procedures for these mRNA vaccines [made by Pfizer-BioNTech and Moderna] needs a terrible focus, “Hogue said. You just have to be more discriminating with the help you render toward other people. “
The Pfizer vaccine, which until recently was always stored in dry ice, is particularly challenging. After freezing and melting Pfizer vials, saline solution is introduced into each vial. If the syringe preparer does not remove air from the vial after adding the saline, the vaccine will evaporate.
After adding the solution, “you take the vial between thumb and forefinger and gently make a rainbow sweep 10 times to mix the lifts together,” Hogue said. Vaccination may be ineffective.
Each Pfizer vaccine contains just a bead of liquid – about 1/16 of a teaspoon – and pharmacists must use tiny syringes in which air bubbles tend to form. But they can’t tap on the syringe to get the blister out, because that could also damage the vaccine, Hogue said.
To get six doses out of the Pfizer filters you need a type of plunger that pushes the last trace of the vaccine out of the syringe. But about 15% of the filters the federal government has delivered to Loma Linda with larger needles that leave little vaccine in the syringe, making it impossible to extract all six doses, he said. So Loma Linda has been buying her own syringes instead of the inappropriate ones.
The US Pharmacopeia, a non-profit organization that sets standards for the use of medical products, has issued an 11-page guide on how you can store, handle and administer the covid vaccines. Among other things, he urges vaccination sites to set up clean rooms – separate from the areas where vaccines are being given – to prepare the filters, said Farah Towfic, Head of operations for USP.
“That way our clients don’t breathe,” not to mention welcoming old acquaintances who are overwhelmed with enthusiasm about getting their vaccine, said Patricia Slattum, a professor of pharmacy school at Commonwealth University in Virginia who has volunteered at a large vaccine site in Richmond, Virginia. “There’s a lot of love in going around there.”
Another way is to insert each needle into a different place on the rubber vial stopper. If the syringe enters the same area over and over again, it can create a large hole that causes leakage. This crop is especially important now that Moderna is in talks with the FDA to introduce up to 15 doses of vaccine in each vial, resulting in 15 punctures of the stopper, Anna Legreid Dopp noted, director of clinical leadership and quality improvement at the American Association of Health-System Archers.
“To pull the vaccine up, you stick a needle through the rubber stopper, and then turn the vial upside down,” Slattum said. “If you keep it in the same place, drones will drop the needle. So there’s an art not to miss a vaccine.”
Slattum hopes the FDA will consider allowing vaccines to drain the remaining vaccine from two vials. “All of us who are doing this work feel this pressure, that doing it well is one of the ways we can get out of this pandemic,” said Slattum. “You just don’t want to have any vaccines!”
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