Vaccine Verification in the COVID-19 World.

As the coronavirus disease-2019 (COVID-19) pandemic evolves, strategies to keep businesses and schools open in the United States (U.S.) while sustaining the economy and maintaining public health safety remain paramount. Vaccine verification (also termed vaccine or immunity passport), a document in either paper or digital format that provides proof of a person's vaccination status against a particular infectious disease, is a strategy to facilitate such goals. Routinely used in many parts of the U.S. and internationally prior to the COVID-19 pandemic, vaccine verification creates safer environments in schools and workplaces, including healthcare settings. Nevertheless, for COVID-19 vaccination, verification has generated substantial controversy, with concerns raised about forgery and the prospects that adopting such passports will lead to discrimination and/or exacerbate existing social and economic inequities. To help address these concerns, we explore the issue of vaccine verification broadly and conclude by offering recommendations for designing, implementing, and maintaining COVID-19 verification systems.

Who historically has verified vaccination?

Every U.S. state requires vaccination to attend primary and secondary school, and many states have requirements for day care and colleges. Many healthcare systems require vaccination of their employees. In these situations, the entity requiring vaccination (e.g., school, university, and health system) establishes the method for verification.

How have institutions historically verified vaccination?

Verifying vaccination often requires a form that an individual's primary care provider (or historically, a parent) completes. Many states or regions allow schools to access immunization information systems, thereby permitting direct access to records by the school officials responsible for ensuring vaccine compliance. Colleges and health systems that require vaccinations also have similar verification processes.

Beyond the U.S., the International Certificate of Vaccination or Prophylaxis (ICVP) or the Yellow Card is a well-established travel document created by the World Health Organization and required by some countries for entry. Notably, several countries, including Nigeria, Zambia, and Zimbabwe, are developing digital certificates that can authenticate an ICVP. As of July 2019, Nigeria requires its citizens to have its digital “e-Yellow Card” for travel outside the country. Like many verification systems in other nations, the card has a quick response (QR) code that can be scanned to verify its validity.

What are the responsibilities of vaccine providers?

Everyone who chooses to be vaccinated has a right to have that vaccine documented in a manner that is accurate, includes pertinent information (e.g., name of person vaccinated, vaccine type and manufacturer, date[s] of vaccination), and can reasonably be used for vaccine verification. The primary responsibility for providing individuals with this documentation lies with the entity that provided the vaccine. This may include healthcare providers, pharmacies, mass vaccination sites, or any other entity authorized to deliver the vaccine.

COVID-19 vaccine verification

COVID-19 vaccine verification systems are most justifiable in countries in which vaccines have been approved and recommended by appropriate regulatory bodies as safe and effective and are widely available and equitably distributed. In the U.S., states and regions use immunization information systems (IIS), confidential and population-based digital databases that track and record individuals’ vaccination status, but the U.S. does not have a national IIS. For this reason, many states, including California, New York, and Colorado, and private companies have developed a digital platform to show proof of COVID-19 vaccine status and test results for domestic and international travel, while European nations have adopted similar systems (Table 1 ).5, 6, 7, 8, 9 However, these applications vary in quality. Likewise, the existence of different public and private, domestic and international platforms present challenges to ensuring that individuals do not need to sign up for multiple databases for different activities.

Table 1

Examples of U.S. and Global COVID-19 Vaccine Verifications.

Name	Developer(s)	Location	Purpose
Excelsior Pass5	New York Government and International Business Machines Corporation	New York, U.S.	Proof of COVID-19 vaccination and COVID-19 test results for domestic travel
Travel-Ready Center5	United Airlines	U.S.	Proof of COVID-19 vaccination and COVID-19 test results
Digital COVID-19 Vaccine Record6	California Government	California, U.S.	Proof of COVID-19 vaccination for domestic travel
Hawaii Safe Travels6	Hawaii Government	Hawaii, U.S.	Proof of COVID-19 vaccination for domestic and international travel
MyIRMobile6	MyIRMobile	Arizona, Louisiana, Maryland, Mississippi, North Dakota, Tennessee, Washington, West Virginia, and Washington DC	Proof of COVID-19 vaccination for domestic travel
myColorado App6	Colorado Government and myColorado	Colorado	Proof of COVID-19 vaccination and COVID-19 test results.
LA Wallet6	Louisiana Government and Envoc	Louisiana	Proof of COVID-19 vaccination.
Green Pass7	Government	Israel	Proof of COVID-19 vaccination, and recovery from COVID-19 for domestic travel
My COVID Pass7	Africa's Centers for Disease Control and Prevention, PanaBIOS Consortium, and Econet Group	Africa	Proof of COVID-19 vaccination and COVID-19 test results
Digital Green Certificate5	European Union Council	European Union Member States	Proof of COVID-19 vaccination, COVID-19 test results, and COVID-19 recovery for international travel
COVID-19 Passport “Coronapas”8	Government	Denmark	Proof of COVID-19 vaccination and COVID-19 test results for domestic travel
VaccineGuard9	Guardtime	Estonia, Iceland, and Hungary	Proof of COVID-19 vaccination for domestic and international travel
ArriveCan6	Government	Canada	Proof of COVID-19 vaccination and COVID-19 test results for international travel
Travel Pass6	International Air Transport Association	Global	Proof of COVID-19 vaccination and COVID-19 test results
VeriFLY6	VeriFLY	Global	Proof of COVID-19 vaccination and COVID-19 test results
Smart Vaccination Certificate7	World Health Organization	Global	Proof of COVID-19 vaccination for domestic (e.g., sporting events or college campuses) or international travel

Considering existing verification systems and the parameters specific to COVID-19 vaccines, we recommend the following steps to implement effective COVID-19 vaccine verification programs:

The U.S. Department of Health and Human Services (HHS) should use its powers to create a national vaccine registry, which should include all vaccines. Under section 361 of the Public Health Service Act (42 U.S. Code § 264), the U.S. Secretary of HHS is authorized to take measures to prevent the entry and spread of infectious diseases from foreign countries into the United States and between states.

The Centers for Disease Control and Prevention (CDC) or the HHS Office of the National Coordinator for Health Information Technology should establish standards for certifying COVID-19 vaccination, which states and private companies can then use to develop and maintain reliable, accurate proof of COVID-19 vaccination and eventually boosters.

State and regional health departments should validate vaccination status for third parties, at the request of the vaccinee, and develop digital platforms, with a print option (to reduce the potential of exacerbating existing social and economic inequities), to show proof of vaccination.

Existing state laws prohibiting fraudulent documentation (e.g., driver's license) should be applied to vaccine verification to reduce fraud and abuse.

Overall, given the importance of vaccine verification programs, especially during the COVID-19 pandemic, clearly formulated protocols offer economic and public health benefits and should be implemented to create safer environments in school, work, and healthcare settings.

Declaration of interests

The Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA is co-hosted by the Yale Institute for Global Health and the Baylor College of Medicine. DAS reports grants from Merck and personal fees from Pfizer, outside the submitted work, and also serves as a paid consultant on Janssen's advisory board. NTB reports personal fees from WHO, CDC, and Merck outside the submitted work. RMC reports receiving research grant funding from Novo Nordisk Foundation (Denmark), outside the submitted work. YAM is a member of a Data Safety Monitoring Board for Pfizer and a site PI for a Pfizer vaccine trial, outside the submitted work. The other authors declare no competing interests.