Proper vaccine preparation, handling and storage are essential to help ensure quality from the minute a vaccine enters a vaccination site to the second it is injected into a patient’s arm. USP staff collaborated with pharmacy, medical and nursing associations, as well as Expert Volunteers and government agencies, to fill in the gaps associated with the “last 25 feet” of COVID-19 vaccines.
As the vaccine rollout began, inconsistency and uncertainty around COVID-19 vaccine supply, access and distribution arose throughout the U.S. In response to this public health need, USP quickly convened and worked with front-line practitioners to help ensure that vaccines got to patients by creating consistencies, enhancing provider confidence and building patient trust.
To address the gaps identified by front-line healthcare practitioners, USP’s Healthcare Safety & Quality Expert Committee (HSQ EC) led the development of the COVID-19 Vaccine Handling Toolkit, which contains operational considerations1 for COVID-19 vaccines authorized2 by the U.S. Food and Drug Administration (FDA). The Toolkit provides individuals preparing and administering vaccines with information about the following:
- Vaccine preparation and labeling
- Vaccine storing, handling and transporting
- Waste minimization and ancillary supply disposal
Nimble expert committees drive agile and rapid response
The HSQ EC developed the Toolkit quickly. Streamlined collaboration across five ECs created the agility needed for USP to convene interdisciplinary specialists and healthcare practitioners with expertise in compounding, packaging, labeling, nomenclature, distribution and storage. “Having all of these Experts Volunteers enabled a robust response to the problems facing individuals setting up vaccination services,” said the Chair of USP’s HSQ EC, Dr. Melody Ryan, Pharm.D., M.P.H.
“In the beginning, it was very common to see the vaccine rollout differ across counties and states. USP’s operational considerations drive consistency, which is essential when different individuals are preparing and administering the same vaccines.”
Dr. Farah Towfic, Pharm.D., M.B.A., Director of CEO Operations at USP and lead for the Toolkit.
Informed by real-world experience, the Toolkit addresses critical gaps
The real-world experience of frontline healthcare practitioners helped ensure that the operational considerations addressed critical gaps.
Dr. Ryan said field personnel identified the need for clear guidance on the best way to transport vaccines to vaccination sites in all the various forms—frozen vials, thawed vials and pre-drawn syringes. As individuals acquired additional field experience, they began asking for information about maximizing the doses from vials and maintaining the integrity of vial stoppers.
Given the limited supply of COVID-19 vaccines, practitioners utilized strategies to minimize vial leakage and optimize vial pressure using reconstituted vaccine vials across several practice settings to ensure personnel could consistently obtain the optimum number of doses per vial.
Preparing vaccines and increasing administration rates
Frontline healthcare practitioners are working across the country to administer scarce COVID-19 vaccines quickly to hundreds of millions of people while ensuring vaccine quality and patient safety.
“When designing the Toolkit, it was prudent to recognize the myriad of settings where the vaccines are stored, transported, prepared and administered, and to provide specific guidance on protecting vaccine integrity, and ultimately patient safety, by including strategies to effectively use the beyond-use dates offered by the manufacturers,” said Dr. Kevin Hansen, Pharm.D., M.S., Compounding EC member. “This provided the flexibility needed to maximize vaccine administration capacity.”
Implementing the operational considerations contained in USP’s Vaccine Handling Toolkit has led to increases in daily shots at vaccination sites of 50%–150%.
A future- ready collaborative framework
The value of COVID-19 vaccines as public health tools depends on their successful administration. However, across the U.S., poor vaccine handling and storage has led to vaccine waste and diminished supply. USP staff continue to engage and convene experts to help ensure vaccines are safely and properly handled, stored and administered.
1 - The Vaccine Handling Toolkit is for informational purposes only and is intended to address operational considerations for COVID-19 vaccine preparation during the COVID-19 pandemic. This does not reflect the USP Healthcare Safety and Quality Expert Committee’s opinions on future revisions to official text of the USP–NF. Parties relying on the information in this document bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements. USP is actively monitoring the evolving situation and will update this document accordingly.
2 - FDA has not approved a COVID-19 vaccine. In response to the pandemic, however, FDA has issued three Emergency Use Authorizations for COVID-19 vaccines.