AIR FORCE ACADEMY, Colorado — Across the country, health care providers began administering the Pfizer COVID-19 vaccine this week.
And commonly, the people preparing the doses found something they weren’t expecting inside the bottle: enough for a full, extra dose.
“We had a little heads up from Pfizer that there may be some overfill in the vials,” said Casey Dugan, Vice President of Pharmacy Services for Children’s Hospital Colorado. “Overfill in a sterile vial is common in pharmaceutical manufacturing. What we didn’t know is how much overfill there would actually be in within the vial.”
It was enough, Dugan said, to consistently give a full sixth dose.
“So it was pretty exciting at that time and just waiting for some guidance from the FDA on how on proceed forward,” he said.
As those responsible for administrating the vaccine waited for guidance from the U.S. Food and Drug Administration (FDA), they balanced excitement for the potential of more doses with concern over safety practices and rules when dealing with a vaccine under emergency use authorization. The Pfizer vaccine is sensitive to storage temperature and time limits.
“I think we’re all very anxious to get the vaccine in as many arms as possible,” said Holly Monatt, Division Director of Clinical Pharmacy for HCA/HealthOne in the Denver area. “We advised our clinics very closely to keep eye on that stopwatch time for when the vials would be expiring.”
Monatt said their teams capped and sealed the extra doses if they got a quick enough answer about what to do. She said at least one cycle had to be discarded before the guidance was clarified.
That guidance came Wednesday from the FDA, which tweeted:
“At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue.”
The FDA added vaccine administrators should not pool from multiple vials to create a full dose.
With so many people eager to receive the vaccine, some have wondered if the people who get the “extra” dose from the Pfizer vials will be guaranteed the second booster shot required later.
“We had considered that,” Monatt said. “What we’re operating under the assumption of is that the vials well get subsequent to this will contain at least a similar amount of overfill.”
After an especially challenging year, the pharmacists are excited for some good news and more doses of a vaccine that will hopefully protect their frontline colleagues treating COVID-19 patients.
“Actually, having the vaccination in hand and being able to start this process gives that glimmer of hope this may be beginning of end to this pandemic,” Dugan said.
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