U.S. Pharmacopeia Identifies and Addresses Operational Efficiency Gaps Across the U.S., Helping to Increase COVID-19 Vaccinations

Independent scientific organization and expert volunteers release latest version of the COVID-19 Vaccine Handling Toolkit

Rockville, Md., June 24, 2021 – U.S. Pharmacopeia (USP) has released the newest version of its COVID-19 Vaccine Handling Toolkit: Operational Considerations for Healthcare Practitioners (Toolkit). It includes expanded refrigerator storage time for Pfizer-BioNTech COVID-19 vaccine vials; considerations for maximizing doses from new, larger-size Moderna COVID-19 vials, similar to those in USP’s related Pfizer-BioNTech max dose guide; revised Moderna vaccine beyond-use date information; and additional strategies to help safely and efficiently prepare COVID-19 vaccines, and minimize waste, while supporting quality and trust.

For the Pfizer-BioNTech COVID-19 vaccine alone, the Toolkit strategies have helped vaccination sites consistently and efficiently maximize doses per vial, for an increase in the number of doses available estimated at about 20 percent – or approximately 16 million doses, enough to vaccinate 8 million people.

“Since its initial release in January 2021, USP’s COVID-19 Vaccine Handling Toolkit has supported the public health response to the coronavirus by helping healthcare professionals quickly and safely vaccinate more people, maximize every dose available, all while maintaining quality,” said Jaap Venema, Ph.D., executive vice president and chief science officer for USP. “The caliber of passion and talent of those who created and continue to contribute to the Toolkit in response to user feedback and new information is evident, and we are grateful to work with such dedicated experts as we help build the public’s trust in COVID-19 vaccines and treatments.”

USP’s COVID-19 Vaccine Handling Toolkit is organized into three sections: Preparation; Storage and Transportation; and Waste Minimization and Ancillary Supply Disposal. It provides strategies to support efforts to:

  • Prepare and administer vaccines at different locations by different individuals
  • Pre-draw the vaccine into syringes
  • Maximize doses withdrawn per vial
  • Ensure quality management systems are in place for vaccine handling
  • Transport the vaccine and ancillary supplies
  • Minimize vaccine waste
  • Safely dispose of ancillary supplies and dry ice
  • Re-distribute ancillary supplies, when applicable

The Toolkit, a free resource, was developed and continues to be updated 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 and Drug Administration (FDA). It is informed by USP’s public quality standards for compounding, microbiology, containers, distribution, stability, and storage.

“Identification of some of the efficiency gaps during the early stages of the COVID-19 vaccine rollout, specifically for consistently maximizing doses per vial of COVID-19 vaccines, as well as solutions to address those gaps, was done by pharmacists,” said Melody Ryan, PharmD, MPH, chair of the U.S. Pharmacopeia Healthcare Safety & Quality Expert Committee and director, International Professional Student Education with the University of Kentucky College of Pharmacy. “Chairing the Expert Committee that developed and continues to update the USP COVID-19 Vaccine Handling Toolkit is an honor, and our work reflects how critical it is to have a trusted tool with strategies to reduce confusion and enhance education for everyone involved with this historic vaccination effort.”

Related Toolkit resources from USP include the “Maximizing Doses of Moderna COVID-19 Vaccine” guide, “Maximizing Doses of Pfizer-BioNTech COVID-19 Vaccine” video and guide, “Beyond-Use Date in Vial or Syringe for COVID-19 Vaccines” factsheet, “Transporting COVID-19 Vaccines Off-Site” guide, and “FAQs for Optimizing COVID-19 Vaccine Preparation and Safety.” These resources can be accessed through the Toolkit at: https://www.usp.org/covid-19/vaccine-handling-toolkit.

A new international COVID-19 vaccine handling guide, tailored for use in geographies outside the U.S., is also under development and anticipated to be available in the coming weeks.

About USP

USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit www.usp.org.