WASHINGTON — The FDA updated the Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine to allow physicians and pharmacists to extract an additional dose from each vial.
The original EUA for Pfizer’s Covid vaccine approved vials that were supposed to contain five doses; however, pharmacists found that the vials often contained enough vaccine for up to six shots — particularly when using low dead-volume syringe, which are designed to limit the “dead” space between the syringe hub and needle and prevent inaccurate dosing.
“After dilution, vials of Pfizer-BioNTech Covid-19 Vaccine contain six doses of 0.3mL of vaccine,” the FDA wrote in the EUA Fact Sheet. “Low dead-volume syringes and/or needles can be used to extract six 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.”
The agency clarified that, irrespective of the type of syringe and needle being used, each dose must contain 0.3 mL of the vaccine. If the amount that is left over in the vial is not enough to provide a full sixth dose, discard the vial and any excess vaccine, the FDA added. The updated EUA also directs physicians and pharmacists not to pool excess vaccine from multiple vials to create more doses.
Pfizer jumped at the news of the surprise six vaccine doses and insisted that these extra doses be counted towards its previous commitment to provide the U.S. with 200 million doses by the end of July, according to The New York Times. However, pharmacists noted that some vaccination sites are struggling to make use of these extra vaccine doses. “Now there’s more pressure to make sure that you get that sixth dose out,” Michael Ganio, PharmD, MS, BCPS, FASHP, senior director for pharmacy practice and quality at the American Society of Health-System Pharmacists, told the Times.
And not every location has access to the supplies needed to mete out these doses, Sanjay Gupta, MD, CNN’s chief medical correspondent told CNN. “Many places have [low dead-volume syringes],” he said, “but not every place.”
As of Jan. 24, the CDC reported that approximately 18.5 million people have received at least one vaccine dose so far, and 3.2 million are now fully vaccinated.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 31
Topic ID: 79,31,730,933,31,926,192,561,927,151,725,928,925,934
