Photo By EJ Hersom | Ms. Marion Whicker, a member of the Senior Executive Service, explains the components...... read more read more
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Operation Warp Speed is updating processes and boosting supply kits to accommodate more doses of COVID-19 vaccine than originally planned.
All indications during the vaccine planning effort, including guidance of the initial Food and Drug Administration-authorized label for the Pfizer-BioNtech COVID-19 vaccine, confirmed each Pfizer vaccine vial would yield five doses.
After the product rolled out and reports from the field indicated many locations were drawing a sixth dose, the FDA updated the Pfizer fact sheet. The FDA’s revised guidance and instructions to healthcare workers recognized that after dilution, vials of the Pfizer-BioNTech COVID-19 vaccine contain six – rather than five – doses with the use of a specialty low dead-volume needle and syringe.
The syringes, needles and other supplies needed to administer vaccines are packaged and delivered to the jurisdictions as part of Operation Warps Speed’s distribution efforts. As vaccines arrive at their final destination, so do the ancillary kits that contain all the necessary supplies to get shots in arms. Along with needles and syringes, the kits include alcohol swabs, face masks and face shields for administrators and shot card reminders for a second dose.
In response to the additional doses, new, larger kits will begin shipping this week.
“In the months preceding vaccine rollout, we configured more than 56,000 kits to support the Pfizer vaccine, ready to be shipped alongside the vaccine,” explained Operation Warp Speed Deputy Chief of Supply, Production and Distribution Marion Whicker. “Each ancillary kit was built to support 975 Pfizer doses, with a 5% overage for contingencies.”
The ancillary kits were assembled based on the Pfizer vaccine packaging trays that resemble small pizza boxes, each containing 195 vials. Planning indicated that each vial would yield five doses, or 975 doses per tray. A consistent sixth dose in each vial equates to 195 extra doses – or a total of 1,170 doses per tray.
Whicker said obtaining six doses from each vial presents an unanticipated challenge, but it’s a great challenge to face.
“We are sourcing additional supplies, and our partner, McKesson, is inserting the additional materials into the pre-packaged kits and preparing them for immediate delivery,” Whicker said. Each supplemented kit will contain enough supplies to support 1,170 doses per tray.
The FDA also indicated that use of low dead-volume syringes and/or needles were a factor in the ability to extract six doses.
“If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial,” according to the FDA’s revised fact sheet for healthcare providers administering the vaccine.
Different brands and types of needles and syringes contain varying amounts of dead space - an area that retains some fluid after fully depressing the plunger. This dead space, while small, results in some discarded product. The smaller – or lower volume – of the dead space, the less wastage.
“We are pulling from across the world-wide supply chain ecosystem for the right type of needles and syringes to meet this new requirement,” she said. “We are augmenting thousands of the kits we had prepared to support the Pfizer vaccine. We are expanding both the amount of equipment and the variety of low dead-volume syringes and needles, which are specialty items.”
The updated FDA fact sheet expanding to six doses will impact the allocations provided to jurisdictions, as well. In the coming weeks, after systems and processes are updated, allocations will reflect 1,170 doses per Pfizer tray.
“The requirements shifted, and we are adjusting,” Whicker said. “While we adapt to changes, our mission to deliver vaccines to Americans continues, and we remain focused on that.”
| Date Taken: | 01.19.2021 |
| Date Posted: | 01.19.2021 15:11 |
| Story ID: | 387143 |
| Location: | US |
| Web Views: | 619 |
| Downloads: | 2 |
This work, Supplies added for extra Pfizer doses, by Lisa Simunaci, identified by DVIDS, must comply with the restrictions shown on https://www.dvidshub.net/about/copyright.
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