USP Expands Global COVID-19 Response to Tackle Substandard & Falsified Vaccines

The post below was originally published on the U.S. Pharmacopeia's website (see full blog post) and written by Jaap Venema, Ph.D., executive vice president and chief science officer for USP.

The challenges posed by COVID-19 transcend international borders and require global solutions. This includes addressing the potential for substandard and falsified (SSF) COVID-19 vaccines, particularly in low- and middle-income countries. At the U.S. Pharmacopeia (USP), we’ve produced a suite of resources to help the people who are responsible for managing the risks and ensuring trust in quality-assured COVID-19 vaccines.

Newly available USP resources address the risks of SSF COVID-19 vaccines by outlining practical steps and resource-efficient interventions that governments, regulators, manufacturers, healthcare practitioners and others can take to help identify SSF vaccines and ensure quality. Developed by leveraging the expertise of hundreds of independent expert volunteers and USP staff in collaboration with other stakeholders, the new resources expand on USP’s established role as an independent provider of science-based public quality standards – and as a trusted partner in building regulatory capacity in countries around the world – with the goal of helping stakeholders deliver quality-assured vaccines. In turn, this will help build and maintain trust, reduce vaccine hesitancy, get more shots in arms, and end the COVID-19 pandemic while helping to prepare for future pandemics. The new USP resources include:

  • USP’s white paper, entitled “Confronting Substandard and Falsified COVID-19 Vaccines: Strategies and Tools For Use In Global Settings.” It outlines reported instances of SSF COVID-19 vaccines, their public health implications and potential solutions. Solutions to help identify and combat SSF vaccines include the use of public quality standards, enhanced global cooperation against falsified medicines, and building and strengthening regulatory capacities. Regulatory measures include risk-based post-market surveillance, reporting and product traceability initiatives
  • USP’s COVID-19 Vaccine Quality Assessment Toolkits. This resource incorporates free access to select chapters of the U.S. Pharmacopeia-National Formulary (USP-NF) documentary standards and related information to support development and validation of processes for vaccine quality testing. Testing of a vaccine’s physical and chemical quality attributes can help stakeholders secure local authorization or approval of quality-assured COVID-19 vaccines, and address risks of SSF vaccines.
  • USP’s Falsified COVID Vaccine Visual Inspection Guide. It includes information to aid healthcare practitioners and vaccine handlers in identifying counterfeit COVID-19 vaccines – with guidelines on what to look for, side-by-side comparisons for evaluation of packaging and vials, and recommended actions – while helping to build a foundation of vigilance and quality assurance for future health crises.
  • USP’s International COVID-19 Vaccine Handling Guide. The guide, which is an international version of USP’s U.S.-focused vaccine handling toolkit, contains operational strategies in a single resource to address potential efficiency gaps – in vaccine preparation, storage and transportation, and waste minimization and ancillary supply disposal – to help vaccine administrators get more shots in arms quickly and safely while maintaining quality.

With these and other resources, USP aims to provide the organizations and people around the world who are focused on quality with the benefits of lessons learned by USP’s independent expert volunteers and vaccine administrators on the ground. The goal is to facilitate global adoption of best practices and availability of quality-assured vaccines that support public trust.

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