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.

Addressing the Risks Head-On

The risks of SSF COVID-19 vaccines stem in part from uneven global access to vaccines and regional demand that outstrips supply. This can create economic incentives for deliberate falsification of vaccines by bad actors as the world struggles to deliver timely shots to billions of people. Examples of SSF COVID-19 vaccines around the world include a falsified version discovered in a Poland apartment in April 2021¹, scores of falsified COVID-19 vaccine doses in Mexico², and thousands in India³. The unique handling requirements of COVID-19 vaccines – such as ultracold supply chains for some versions, as well as evolving stability and expiry data – also can create conditions for vaccines to become substandard through improper handling, distribution and storage. Without action the incidence and prevalence of SSF COVID-19 vaccines, and related news reports that can undermine trust in the vaccines, are only poised to increase. At USP, we’re addressing these risks head-on.

Building Capacity to Respond

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.

Supporting Quality Treatments

Beyond vaccines, USP has assembled resources to help manufacturers, regulators and quality control laboratories ensure quality and trust in COVID-19 treatments. Related USP resources released earlier this year include Methods to Assist in Detecting Falsified Remdesivir, an antiviral medicine; and USP’s white paper on Substandard and Falsified Health Products. USP also worked with the Global Pharma Health Fund to develop a Minilab screening tool for dexamethasone, a corticosteroid treatment; and with the World Health Organization’s International Meeting of World Pharmacopeias to develop draft monographs for favipiravir, an antiviral treatment, to help combat SSF COVID-19 treatments.

Building Trust Every Step of the Way

Ensuring global availability of quality-assured vaccines and treatments is essential to addressing pandemics like COVID-19. Quality is the foundation upon which trust is built to facilitate delivery of the medicines people rely on to maintain health. That’s why USP is proud to work with stakeholders around the world to provide standards and other resources that help ensure quality and trust every step of the way, for the benefit of those in need all over the world.

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^{1 Taylor P. More fake Pfizer/BioNTech COVID shots found, this time in Poland. April 21, 2021. Securing Industry. https://www.securingindustry.com/pharmaceuticals/fake-pfizer-biontech-c…. Accessed July 30, 2021.}

^{2 BBC. Coronavirus: Pfizer confirms fake versions of vaccine in Poland and Mexico. April 22, 2021. BBC News. https://www.bbc.com/news/world-56844149. Accessed July 30, 2021.}

^{3 Healthworld.com. Over 2,000 in Mumbai duped in fake vaccine drives, says govt. June 25, 2021. The Economic Times. https://health.economictimes.indiatimes.com/news/industry/over-2000-in-…. Accessed July 30, 2021.}