USP’s New Tools with Practical Strategies to Help Detect Substandard & Falsified COVID-19 Vaccines and Ensure the Quality of COVID-19 Vaccines Along the Supply Chain

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Resources build on collaboration with vaccine manufacturers, global health organizations, and country partners to help address developing needs and challenges, and support public trust in COVID-19 vaccines

Rockville, MD, August 17, 2021 – The U.S. Pharmacopeia (USP) released two new resources that can help countries build foundational frameworks and broaden efforts to help ensure and maintain the quality of COVID-19 vaccines as they travel through the supply chain, identify substandard and falsified vaccines, and aid distribution efficiencies in geographies around the world.

“As efforts continue to immunize people everywhere against COVID-19, countries are facing common challenges in manufacturing, distribution and delivery processes,” said Anthony Lakavage, J.D., USP’s Senior Vice President of Global External Affairs. “USP’s best practices and strategies provide countries science-based tools and interventions to help ensure quality in both the manufacture and distribution of COVID-19 vaccines.”

The new USP tools include:

  • The Vaccine Quality Attributes Toolkit, which can help countries build a framework that adheres to quality standards for COVID-19 vaccines, ensures adequate resources and training, and strengthens surveillance systems and technology.
  • The International COVID-19 Vaccine Handling Guide, which can help healthcare practitioners create operational efficiencies to get more shots in arms quickly and safely.
    • This includes a Visual Inspection Guide on what to look for, with side-by-side comparisons for evaluating vaccine packaging and vials, to help frontline workers identify falsified COVID-19 vaccines.

High global demand and insufficient supply have resulted in an inequitable global distribution of COVID-19 vaccines, creating an economic incentive for fake vaccines to enter the market.  While ensuring authenticity of vaccines is fundamental, it is not sufficient to guarantee quality. Improper production, distribution, storage, and handling of COVID-19 vaccines can also create conditions that could result in substandard versions.

“The challenge of substandard and falsified COVID-19 vaccines will grow as vaccines are introduced globally, reducing the ability of immunization to save lives and hindering the public’s trust and the ability to control this pandemic,” said Jaap Venema, Ph.D., USP Chief Science Officer. “With these resources, USP hopes to help healthcare practitioners and vaccine handlers identify fake or substandard COVID-19 vaccines, prevent them from reaching patients, and build a foundation of vigilance, quality assurance, and trust for this and future health crises.”

An Oxford University report found 120 instances of diverted or substandard/falsified COVID-19 vaccines coming from 35 countries (as of May 2021). Even before COVID-19, substandard and falsified medicines posed a significant threat to global health. Poor-quality medicines reportedly cause more than one million deaths per year and are known to reduce the effectiveness of medical treatment, waste household and national resources, and contribute to antimicrobial resistance.

For over 200 years, USP has supported the development, manufacturing, and distribution of quality medicines through our rigorous science, the public quality standards we set, and related resources. USP is working with government organizations, other pharmacopeias, manufacturers of drugs and other health products, and healthcare professionals in the U.S. and around the world to help build the public’s trust and improve the supply of safe, trusted COVID-19 vaccines, treatments, and preventatives. For more information, go to

The USP resources provided are intended as informational resources only. Parties relying on these resources bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.

About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are legally recognized in the U.S. and elsewhere, and are used in more than 150 countries. These standards are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia. Learn more at