The rollout of COVID-19 vaccines has received national and international attention. As part of our ongoing COVID-19 response, the U.S Pharmacopeia (USP) rapidly engaged stakeholders and convened experts to identify and help address operational efficiency gaps across U.S. states and territories to help increase COVID-19 vaccinations.
The COVID-19 Vaccine Handling Toolkit is developed by over 30 independent expert volunteers led by USP’s Healthcare Safety and Quality Expert Committee with representation from several other Expert Committees including U.S. government representatives from the Centers for Disease Control and Prevention (CDC) and the U.S. Food & Drug Administration (FDA). It is informed by USP’s public quality standards for compounding, microbiology, containers, distribution, stability and storage.
The COVID-19 Vaccine Handling Toolkit provides strategies that can support healthcare practitioners to:
- Prepare and administer vaccines at different locations by different individuals
- Pre-draw the vaccine into syringes for efficient administration
- Maximize doses per vial
- Ensure quality management systems are in place for vaccine handling
- Transport the vaccine and ancillary supplies
- Minimize vaccine waste and safely dispose of ancillary supplies
- Safely dispose of dry ice
Version 3.0, released on March 12, features updates related to:
- Preparation, storage and transportation considerations including beyond-use date information for the newly authorized Johnson & Johnson (J&J) Janssen COVID-19 Vaccine
- Updated transportation and storage information for the Pfizer-BioNTech COVID-19 Vaccine
- Ancillary supply re-distribution considerations, when applicable
The COVID-19 Vaccine Handling Toolkit is an informational resource and is intended to complement the following resources as well as those provided by the CDC, U.S. FDA, vaccine manufacturers, and state and local departments of health:
- CDC Vaccine Storage and Handling Official toolkit (February 5, 2021)
- CDC COVID-19 Vaccination Program Interim Playbook by Jurisdiction Operations (October 29, 2020)
- FDA COVID-19 Vaccine Information
- Pfizer vaccine resources for healthcare providers
- Moderna vaccine resources for healthcare providers
For more information, please contact HealthcareQuality@usp.org.
For over 200 years, USP has worked to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP helps protect patient safety and improve the health of people around the world. Excerpted USP-NF Standards referenced in the USP COVID-19 Vaccine Handling Toolkit are available here.