Extra doses of the COVID-19 vaccine are being found in the vials sent by Pfizer BioNTech that, if used, would allow more people to get the vaccine than originally expected. The opportunity is a rarely granted FDA option to the common practice of overfilling, but not all medical providers in the Valley will be taking it.
The manufacturer sent 14,625 doses of the vaccine in 2,925 vials to the Rio Grande Valley this week. DHR Health and UTRGV were the first of the six providers to receive their allotted doses Tuesday.
Immediately that evening, UTRGV began using the 1,950 doses to vaccinate their staff. The extra supply was quickly noticed.
“‘Hey, there’s a lot left in here,’” Dr. John Krouse, dean of UTRGV School of Medicine, said the director of clinical operations remarked when they extracted the five doses from the vial.
The instructions from the manufacturer, Pfizer BioNTech, were only for five doses per vial. The FDA guidance was also clear. “We knew at that point that the FDA guidance was, ‘yea, we know there’s left some but don’t do it,’” Krouse said.
The next day, Wednesday, the FDA changed their guidance. The agency published a statement via Twitter:
“The FDA is aware that some vials of the Pfizer-BioNTech #COVID19 Vaccine have contained extra product after five doses are obtained. The agency is working with Pfizer to determine the best path forward, and will share additional updates as we have them.”
The FDA is aware that some vials of the Pfizer-BioNTech #COVID19 Vaccine have contained extra product after five doses are obtained. The agency is working with Pfizer to determine the best path forward, and will share additional updates as we have them. https://t.co/0jiiyEmug7
— U.S. FDA (@US_FDA) December 17, 2020
“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.”
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.
— U.S. FDA (@US_FDA) December 17, 2020
While the government is allowing the use of the sixth dose, Pfizer has not changed their directive leaving the healthcare provider with the burden of the decision.
DHR Health received the largest dose allotment in the Valley, 5,850 doses, on Tuesday. On Thursday morning, Valley Baptist Medical Center in Harlingen, the only provider in Cameron County receiving the vaccine this week, welcomed the delivery of 2,925 doses. South Texas Health System announced Thursday evening the arrival of their doses, 975.
Of the three largest providers in the Rio Grande Valley that received the Pfizer BioNTech vaccine, Valley Baptist and UTRGV will be using the sixth dose. DHR Health will not.
“This is very uncommon,” Gavino Garza, vice president of pharmacy services at DHR Health, said referring to the FDA’s decision to allow the use of the extra dose.
It’s common for vials that contain more than one dose — the Pfizer BioNTech vaccine comes with five each — to have a little more in case some may get lost during extraction or injection.
“In general, they’ll have a little bit more in the vial to allow you to give the full amount, knowing that there’s still some that’s going to remain in the syringe ever after the injection,” Krouse said.
“When you’re drawing up, you draw up with syringes, you draw up air. Sometimes you have small spills,” Garza said.
The vials contain the doses in concentrate form. Saline is then added.
DHR Health will continue adding the saline solution for the manufacturer’s instructions of five doses.
“We’re allotted 5,850 doses and I want to assure all the employees, and all the physicians and all the providers that we gave them the full dose of 3mls and nothing less,” Garza said speaking for DHR Health.
A sixth dose, Krouse counters, will have the same potency as the others.
“If the FDA felt that the sixth dose was any less potent, they would not say ‘go ahead and do it,’” he said.
The additional dose will have to be complete and in the same vial. It will not be allowed to collect the remains of multiple vials and combine them to make one vial. That would increase the chance of contamination from the multiple drawings.
“The material that’s in the vaccine, that mRNA that’s encapsulated, is very fragile. The more you manipulate it,” Krouse said, “the more you risk damaging the mRNA.”
The FDA is not allowing that haphazard collection, either. Their Twitter statement on Wednesday concluded stating:
“However, since the vials are preservative free, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.”
However, since the vials are preservative free, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.
— U.S. FDA (@US_FDA) December 17, 2020
The extra dose will be used by providers like UTRGV and Valley Baptist. A second dose will need to be administered in the coming weeks.
Krouse felt confident the extra doses found in the vials will remain consistent.
“I really don’t think there’ll be any difference in those shipments that’ll be coming in the future weeks,” Krouse said.
The drug manufacturer sent a statement that addressed the extra dose stating that every vial has at least five doses. The statement read:
“The amount of vaccine remaining in the multidose vial after removal of five doses can vary, depending on the type of needles and syringes used plus the amount of diluent added. If the amount of vaccine remaining in the vial cannot provide a full additional dose, the vial and any excess volume must be discarded. Excess vaccine from multiple vials must never be pooled. Pfizer continues to closely coordinate with FDA on further guidance for healthcare providers.”
